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類別 法規性質 法規名稱 條文內容 發佈日期 附件檔案
1420459 化學製造管制類,藥物製造/委託製造,生物藥品檢驗封緘作業辦法 法規命令 〈生物藥品檢驗封緘作業辦法〉附件一：生物藥品檢驗封緘申請書 <pre><span style="font-family: &quot;times new roman&quot;,&quot;serif&quot;; font-size: 14pt; mso-fareast-font-family: 標楷體; mso-font-kerning: 1.0pt; mso-bidi-font-family: 'courier new'; mso-bidi-font-size: 10.0pt;" lang="EN-US"><o:O:P><span style="font-family: 新細明體; font-size: 16px;"></span> <table style="border-collapse: collapse; mso-table-layout-alt: fixed; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 480; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;" class="MsoTableGrid" border="1" cellspacing="0" cellpadding="0" width="622"><span style="font-family: 新細明體;"></span><tbody><tr style="mso-yfti-irow: 0; mso-yfti-firstrow: yes;"><span style="font-family: 新細明體;"></span><td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; padding-top: 0cm; mso-border-alt: solid windowtext .5pt;border: windowtext 1pt solid;" valign="top" colspan="7"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">附件一、生物藥品檢驗封緘申請書<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 33.4pt; mso-yfti-irow: 1;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top" rowspan="3"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">申請廠商<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">（蓋印）<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">負責人<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">（簽章）<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 18.75pt; mso-yfti-irow: 2;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">地址<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">電話<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 18.75pt; mso-yfti-irow: 3;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px; text-decoration: underline;">申請<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px; text-decoration: underline;">封緘證明書：<span style="mso-spacerun: yes;" lang="EN-US">&nbsp; </span>份<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; text-decoration: underline;">放行證明（外銷用）：<span style="mso-spacerun: yes;" lang="EN-US">&nbsp; </span>份</span><span style="font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 4;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top" rowspan="7"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: 0.05pt; margin: 0cm 0cm 0pt -1.55pt; mso-para-margin-left: -.13gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">申請檢驗封緘藥品<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">中文名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">藥品許可證字號<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 5;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">外文名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">批號<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 6;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">成分及單位含量<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">有效日期<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 7;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">包裝<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">貯存方法<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 8;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 54pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">原製造廠<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">名稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">進口日期<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">民國<span style="mso-spacerun: yes;" lang="EN-US">&nbsp; </span>年<span style="mso-spacerun: yes;" lang="EN-US">&nbsp; </span>月<span style="mso-spacerun: yes;" lang="EN-US">&nbsp; </span>日<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 9;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">地址<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 352.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="4"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 10;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 54pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: rgb(0,0,0) 0px; padding-top: 0cm; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-bottom-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">進口<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">製造<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-top-alt: solid windowtext .5pt; mso-border-bottom-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt;"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">數量<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 60pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm; mso-border-left-alt: solid windowtext .5pt;border: rgb(0,0,0) 0px;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">封緘<span style="text-decoration: underline;"><span lang="EN-US">/</span>外銷<span lang="EN-US"><o:O:P></o:O:P></span></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -11pt; margin: 0cm 0cm 0pt 5pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; font-size: 11pt; text-decoration: underline;">藥物檢查證</span><span style="font-family: 標楷體; font-size: 11pt;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: rgb(0,0,0) 0px; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 30pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-right-alt: solid windowtext .5pt;"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">數量<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 11; mso-yfti-lastrow: yes;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -5.15pt; margin: 0cm 0cm 0pt -0.85pt; mso-char-indent-count: -.43; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; mso-spacerun: yes;" lang="EN-US">&nbsp;</span><span style="font-family: 標楷體;">應附資料文件<span lang="EN-US"><o:O:P></o:O:P></span></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 442.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="6"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(1)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">輸入包裝清單</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">(Packing list)<span style="mso-spacerun: yes;">&nbsp; </span>(</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">國產製品得免附</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(2)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">生物藥品原產國國家檢驗機關之檢定合格證明</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><span style="mso-spacerun: yes;">&nbsp; </span>(</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">國產製品得免附</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(3)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">衛生署核發藥品許可證或核可文件之影本。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(4)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">生物藥品之製程、檢驗方法、規格及有關文獻。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">□</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：各項原廠證明資料與查驗登記資料相符，請准免送。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(5)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">動物原料來源管制之標準操作程序</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">(SOP)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">及原料來源證明。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">□</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：各項原廠證明資料與前次申請檢驗封緘資料相符，請准免送。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(6)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">本批生物藥品製程之分裝數量紀錄與檢定紀錄及成品之檢定紀錄與成績書。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">□</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">因應防疫或外銷用生物藥品，</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">請准後補資料。（檢附同意函）</span><span style="mso-fareast-font-family: 標楷體; mso-hansi-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;">&nbsp;</span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 31px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 72px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 48px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 168px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 80px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 40px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 182px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span></tbody></table></o:O:P></span><span style="font-family: &quot;times new roman&quot;,&quot;serif&quot;; font-size: 14pt; mso-fareast-font-family: 標楷體; mso-font-kerning: 1.0pt; mso-bidi-font-family: 'courier new'; mso-bidi-font-size: 10.0pt;" lang="EN-US"><o:O:P></o:O:P></span></pre> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4487&type=0
1420460 化學製造管制類,藥物製造/委託製造,生物藥品檢驗封緘作業辦法 法規命令 〈生物藥品檢驗封緘作業辦法〉附件二：生物藥品封緘證明書 <p style="margin: 0cm 0cm 0pt;" class="MsoNormal"><span lang="EN-US"><o:O:P><span style="font-family: arial unicode ms;"><table style="border-collapse: collapse;" border="1" cellspacing="0" cellpadding="0" width="622"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" colspan="2"> <p><span style="font-family: 標楷體; font-size: 18px;">附件二、生物藥品封緘證明書 </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px;border: rgb(0,0,0) 0px;"> <p><span style="font-size: 18px;">&nbsp;</span></p> </td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" rowspan="2" colspan="2"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"><span style="font-family: arial unicode ms; text-decoration: none;">&nbsp;</span><span style="font-family: 標楷體; text-decoration: underline;">行政院衛生署食品藥物管理局&nbsp;</span> </span></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 18px;">生物藥品封緘證明書 </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <span style="font-family: 標楷體; text-decoration: underline;">FDA</span><span style="font-family: 標楷體; text-decoration: underline;">研字第OOOOOOOOOO號 </span></span></p> <span style="font-size: 18px;"></span> <p><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;">&nbsp;</span></p> <span style="font-size: 18px;"></span> <p><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;">&nbsp;</span></p> <span style="font-size: 18px;"></span> <div style="text-align: center;"><span style="font-size: 18px;"></span> <table style="border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <span style="font-size: 18px;"></span> <tbody> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">申請廠商</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p class="a"><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">製劑名稱</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">製造廠名</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">批號</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">有效日期</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">包裝</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">封緘數量</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">封緘劑量</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> </tbody> </table> <span style="font-size: 18px;"></span></div> <span style="font-size: 18px;"></span> <p style="margin-left: 6pt;"><span style="font-size: 18px;"><span style="font-family: 標楷體; text-decoration: underline;">上述生物藥品之封緘檢驗案，符合生物藥品檢驗封緘作業之規定，予以封緘，此證。</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;">&nbsp;</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"><span style="font-family: 標楷體; text-decoration: underline;">局長&nbsp; </span><span style="font-family: 標楷體; text-decoration: underline;">○○○</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;">&nbsp;</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" colspan="2"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;">&nbsp;</span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;">&nbsp;</span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 18px;">中華民國&nbsp; 年&nbsp; 月&nbsp; 日 </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;">&nbsp;</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> </tbody></table><p style="margin: 0cm 0cm 0pt;" class="MsoNormal">&nbsp;</p></span><p style="margin: 0cm 0cm 0pt;" class="MsoNormal">&nbsp;</p></o:O:P></span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4486&type=0
1420461 化學製造管制類,藥物製造/委託製造,生物藥品檢驗封緘作業辦法 法規命令 〈生物藥品檢驗封緘作業辦法〉附件三：外銷用生物藥品批次放行證明書 <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="622"> <tbody> <tr style="height: 31.25pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 31.25pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="12"> <p><span style="font-family: 標楷體;">附件三、外銷用生物藥品批次放行證明書 </span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: left; line-height: 12pt; margin: 0cm 7.1pt 0pt 0cm;" class="a"><span style="font-size: 10pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 209.7pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: left; margin: 0cm 7.1pt 0pt 0cm;" class="a"><span style="color: #414141; font-size: 10pt; font-weight: normal;" class="panelti21">No.161-2, Kunyang St., Nangang District, <br /> Taipei 115-61, Taiwan (R.O.C)</span></p> <p><span style="color: #414141;"><span style="font-size: 10pt; font-weight: normal;" class="panelti21">&nbsp;TEL</span><span style="font-family: 新細明體,serif; font-size: 10pt; font-weight: normal;" class="panelti21">：</span><span style="font-size: 10pt; font-weight: normal;" class="panelti21">886-2-27878000</span> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="8"> <p style="text-align: center;"><span style="font-size: 14pt; font-weight: normal;" class="panelti21"><img width="726" height="255" alt="" style="width: 256px; height: 77px;" src="../Files/NewsUpload/1.png" /></span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="12"> <p style="text-align: center;" class="a"><span style="font-family: harlow solid italic; color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Food and Drug Administration</span></p> <p style="text-align: center;" class="a"><span style="color: #414141;"><span style="font-family: harlow solid italic; font-size: 12pt; font-weight: normal;" class="panelti21">Department of Health, Executive Yuan, Republic of China</span><span class="panelti21"> </span></span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="12"> <p style="text-align: center; line-height: 150%;" class="a"><span style="color: #414141;"><span style="line-height: 150%; font-size: 12pt; font-weight: normal;" class="panelti21">LOT</span><span style="line-height: 150%; font-size: 12pt; font-weight: normal;" class="panelti21">&nbsp; RELEASE&nbsp; CERTIFICATE</span><span class="panelti21"> </span></span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 311.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="8"> <p style="text-align: right;" class="a"><span style="color: #414141;"><span style="font-family: harlow solid italic; font-size: 12pt; font-weight: normal;" class="panelti21">No.</span><span class="panelti21"> </span></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 154.8pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;" class="panelti21">TFDA-RA-XXXXXXXXXX</span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 221.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 201.6pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: right;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;" class="panelti21">MMM. DD, YYYY</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 19.8pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;" class="panelti21">&nbsp;</span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 442.8pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="10"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 14.4pt 9pt -5.25pt;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;">The lot referenced below meets the national requirements for lot release and conforms to the approved specifications. The lot has been tested on the basis of critical evaluation of the manufacture&rsquo;s production and control protocols and on the basis of the evaluation of samples at the Food and Drug Administration. </span></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Product trade name</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Common name</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141;"><span style="font-size: 12pt; font-weight: normal;" class="panelti21">Lot</span><span style="font-size: 12pt; font-weight: normal;" class="panelti21"> number</span></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Expiry date</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Number of containers</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Number of doses per container</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Type of container</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Dosage form</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Strength of the product</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Name and address of manufacturer</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 9.5pt;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;">&nbsp;Signed by </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" rowspan="2" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p><span style="font-family: 標楷體;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 12pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;">Director, Division of Research and Analysis </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 12pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;">Under the delegated authority of </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 12pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 13pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Director-General</span></p> <p style="text-align: left; line-height: 13pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Food and Drug Administration</span></p> <p style="text-align: left; line-height: 13pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Department of Health, Executive Yuan, Republic of China</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;">&nbsp;</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 13pt;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;">&nbsp;</span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;">&nbsp;</p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;">&nbsp;</p> </td> </tr> <tr> <td style="background-color: transparent; width: 18px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 10px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 22px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 220px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 16px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 5px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 12px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 66px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 63px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 118px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 30px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 43px;border-color: #f0f0f0;"></td> </tr> </tbody></table> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4488&type=0
1420462 藥政管理類,成藥及固有成方製劑管理辦法 法規命令 〈成藥及固有成方製劑管理辦法〉附件一 <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 18pt;">成藥及固有成方製劑管理辦法第二條附件一修正規定</span></b><b> </b></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="727"> <tbody> <tr style="height: 403.45pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 545.4pt; padding-right: 5.4pt; height: 403.45pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <table style="margin: auto auto auto 1.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="717"> <tbody> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">劑別 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">主要成分 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">主要效能 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="letter-spacing: 15pt; font-family: 標楷體; font-size: 12pt; text-fit: 139.5pt;">其他規定</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">一)解熱鎮痛劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乙醯水楊酸(Acetylsalicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">咖啡鹼(Caffeine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯芬尼拉明(Chlorpheniramine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">汎司(Acetaminophen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸胺(Salicylamide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">乙氧基苯醯胺</span><span style="font-family: 標楷體; font-size: 12pt;">(Ethoxybenzamide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">溴滑利尿素(Bromvalerylurea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">葛根(Pueraria)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻黃(Ephedra)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">升麻(Cimicifugae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">柴胡(Bupleurum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">芍藥(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大棗(Zizyphus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">生薑(Zingiber)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘草(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桔梗</span><span style="font-family: 標楷體; font-size: 12pt;">(Platycodon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白芷</span><span style="font-family: 標楷體; font-size: 12pt;">(Angelica Glaurao)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">感冒、頭痛、解熱、鎮痛、風濕病、神經痛、齒痛、咽喉病、肩痛、鼻塞、流鼻水。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">二)鎮咳袪痰劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化銨(Ammonium Chloride)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻黃鹼(Ephedrine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">咖啡鹼(Caffeine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">安息香酸鈉(Sodium Benzoate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">東莨菪浸膏(Extract Scopilia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">癒創木酚(Guaiacol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">諾司卡賓(Noscapine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">燐酸可待因(Codeine Phosphate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">美遠志(Senega)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯芬尼拉明(Chlorpheniramine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">松節油(Oleum Terebinthine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">杏仁(苦杏仁Armeniaca Amara、 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甜杏仁Armeniaca Dulcis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">遠志(Polygala)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">小茴香(Foeniculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桔梗(Platycodon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">野櫻皮(Prunus Serotina)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">車前子(Plantaginis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻黃(Ephedra)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麥門冬(Ophiopogon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桑白皮(Morus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">半廈(Pinellia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">紫蘇(Perilla)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">厚朴(Magnolia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茯苓(Hoelen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">柴胡(Bupleurum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">陳皮(Citri Nobilis Cortex)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石膏(Cypsum Fibrosum)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">咳嗽、感冒支氣管炎引起之咳嗽、喀痰、咽喉炎引起之咳嗽。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">三)胃腸藥劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">酵母(Yeast)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化鋁(Aluminum Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">矽酸鋁(Aluminium Silicate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鎂(Magnesium Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鉍或硝酸鉍(Bismuth Carbonate or Nitxrate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鈣(Calcium Carbonate)</span></p> <p style="margin: 0cm 1cm 0pt 11.8pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">縮水蘋果酸氯芬尼拉明(Chlorpheniraamine Maleate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">二苯胺明(Diphenhydramine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸氫鈉(Sodium Bicarbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澱粉酵素(Amylase)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">東莨菪浸膏(Extract Scopoliae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">木溜油</span><span style="font-family: 標楷體; font-size: 12pt;">(Creosote)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">苦木</span><span style="font-family: 標楷體; font-size: 12pt;">(Picrasma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當藥</span><span style="font-family: 標楷體; font-size: 12pt;">(Swertiae Herba)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷腦</span><span style="font-family: 標楷體; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃連鹼</span><span style="font-family: 標楷體; font-size: 12pt;">(Coptisine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乳酸菌製劑</span><span style="font-family: 標楷體; font-size: 12pt;">(Lactic Acid Preparation)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">顛茄葉</span><span style="font-family: 標楷體; font-size: 12pt;">(Belladonna)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃柏</span><span style="font-family: 標楷體; font-size: 12pt;">(Phellodendra)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白朮</span><span style="font-family: 標楷體; font-size: 12pt;">(Atractylodes Ovata)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蒼朮</span><span style="font-family: 標楷體; font-size: 12pt;">(Atractylodes Lancea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">龍膽</span><span style="font-family: 標楷體; font-size: 12pt;">(Gentiana)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">砂仁</span><span style="font-family: 標楷體; font-size: 12pt;">(Amomum Zanthioides)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃連</span><span style="font-family: 標楷體; font-size: 12pt;">(Coptis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘草</span><span style="font-family: 標楷體; font-size: 12pt;">(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">吳茱萸</span><span style="font-family: 標楷體; font-size: 12pt;">(Evodia Rutacecarps)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蘆薈</span><span style="font-family: 標楷體; font-size: 12pt;">(Aloe)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大黃</span><span style="font-family: 標楷體; font-size: 12pt;">(Rheum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">丁香</span><span style="font-family: 標楷體; font-size: 12pt;">(Caryophyllum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">陳皮</span><span style="font-family: 標楷體; font-size: 12pt;">(Citri Nobilis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人參</span><span style="font-family: 標楷體; font-size: 12pt;">(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">藿香</span><span style="font-family: 標楷體; font-size: 12pt;">(Agastache Rugosa)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茯苓</span><span style="font-family: 標楷體; font-size: 12pt;">(Hoelen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">半夏</span><span style="font-family: 標楷體; font-size: 12pt;">(Pinellia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">小茴香</span><span style="font-family: 標楷體; font-size: 12pt;">(Foeniculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澤瀉</span><span style="font-family: 標楷體; font-size: 12pt;">(Alisma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">牡蠣</span><span style="font-family: 標楷體; font-size: 12pt;">(Ostreae Testa)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">延胡索</span><span style="font-family: 標楷體; font-size: 12pt;">(Corydalis Tuber)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸鎂</span><span style="font-family: 標楷體; font-size: 12pt;">(Magnesium Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻子油</span><span style="font-family: 標楷體; font-size: 12pt;">(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鎂(Magnesium Oxide)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">胃痛、胃腸炎、胃內異常醱酵、消化不良、胃酸過多、食慾不振、嘔吐、瀉痢、胃部膨滿。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">四)緩下劑(瀉藥)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大黃(Rheum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蘆薈(Aloe)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻子仁(Linum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">杏仁(苦Armeniaca Amara、甜Armeniaca Dulcis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">番瀉葉(Senna)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">便秘、習慣性便秘、慢性便秘。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">五)驅蟲劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">海人酸(Kainic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">山道年</span><span style="font-family: 標楷體; font-size: 12pt;">(Santonin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">二乙烯二胺</span><span style="font-family: 標楷體; font-size: 12pt;">(Piperazine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">海人草</span><span style="font-family: 標楷體; font-size: 12pt;">(Digenea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">使君子</span><span style="font-family: 標楷體; font-size: 12pt;">(Combretaceae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石榴皮(Cranatum)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蛔蟲、蟯蟲、十二脂腸蟲、絛蟲之驅除。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">六)營養劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">檸檬酸鐵銨(Ferric Ammonium Citrate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">礦物質(Mineral)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氨基酸製劑(Amino Acid Prep.)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">魚肝油(Cod Liver Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人參(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當歸(Angelica)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">川芎(Cnidii Rhizoma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">五加皮(Acanthopanacis Cortex)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">山藥(Dioscorea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大棗(Zizyphus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">女魚子(Ligustrum Lucidum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">維生素B1, B2, B6類 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">鐵劑(Iron Prep.)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蛋白質之補給、食慾增進、營養補給、貧血。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">七)眼藥液劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸鋅(Zinc Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿克利諾兒(Acrinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼砂(Borax)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">結膜炎、眼瞼緣炎、淚囊炎。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">八)漱口劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿克利諾兒(Acrinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸氫鈉(Sodium Bicarbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">漱口：口內消毒。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">九)浣腸劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">緩解便祕。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">1.</span><span style="font-family: 標楷體; font-size: 12pt;">適用範圍：所稱浣腸劑係指</span><span style="font-family: 標楷體; font-size: 12pt;">凡經由肛門投與，以緩解便祕為目的之製劑，均適用本基準</span><span style="font-family: 標楷體; font-size: 12pt;">。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.</span><span style="font-family: 標楷體; font-size: 12pt;">有效成分之種類含量： </span></p> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="346"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 79.35pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">有</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">效</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">成</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">單方濃度範圍</span> </p> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 新細明體; font-size: 12pt;">(w/v) </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">複方濃度範圍</span> </p> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 新細明體; font-size: 12pt;">(w/v) </span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 79.35pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><b>12% ~ 50%</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><b>12% ~ 30%</b></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 79.35pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><b>0.9% ~ 15%</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><b>0.9% ~ 15%</b></p> </td> </tr> </tbody> </table> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">※所規範之浣腸劑為單一劑量之使用，成人</span><span style="font-family: 標楷體; font-size: 12pt;">每單一劑量（顆、粒、丸&hellip;</span><span style="font-family: 新細明體; font-size: 12pt;">..</span><span style="font-family: 標楷體; font-size: 12pt;">）不可大於三十毫升。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 新細明體; font-size: 12pt;">3. </span><span style="font-family: 標楷體; font-size: 12pt;">劑型：</span><span style="font-family: 標楷體; font-size: 12pt;">浣腸劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">4.</span><span style="font-family: 標楷體; font-size: 12pt;">用法及用量：</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">1</span><span style="font-family: 標楷體; font-size: 12pt;">）將一劑注入直腸內，若未見效果時可再注入一劑，一天最多二劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">2</span><span style="font-family: 標楷體; font-size: 12pt;">）</span><span style="font-family: 標楷體; font-size: 12pt;">十二歲以上，適用成人劑量。三歲以上未滿十二歲，適用成人劑量之二分之一。三歲以下之嬰幼兒，請洽醫師診治。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">3</span><span style="font-family: 標楷體; font-size: 12pt;">）使用後之剩餘液需丟棄，不宜留存。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">5.</span> <span style="font-family: 標楷體; font-size: 12pt;">注意事項：</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（1）為防止兒童誤食請妥善保管。 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（2）避免陽光直射，宜保存於陰涼之處。 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（3）除非有醫師藥師藥劑生指示，孕婦及授乳婦不建議自行使用。 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（4）勿超過建議劑量，若有不適情況產生，應立即停藥就醫。 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（5）</span><span style="font-family: 標楷體; font-size: 12pt;">浣腸劑不應長期使用，一旦排便正常，即應停藥。除非<b>有醫師藥師藥劑生</b>指示，不得使用連續一星期以上，應儘量以含纖維飲食，充分攝取水分及運動來改善便祕。 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">6.</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">警語</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">1</span><span style="font-family: 標楷體; font-size: 12pt;">）使用本藥時不得併用其他瀉劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（2）</span><span style="font-family: 標楷體; font-size: 12pt;">禁止用於胃腸阻塞、腹痛、嘔吐、噁心之患者。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">3</span><span style="font-family: 標楷體; font-size: 12pt;">）若發生下列情況，應停藥立即就醫：</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（i）</span><span style="font-family: 標楷體; font-size: 12pt;">腹瀉持續不止或加劇。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">ii</span><span style="font-family: 標楷體; font-size: 12pt;">）有血便及自發性直腸出血狀況。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">iii</span><span style="font-family: 標楷體; font-size: 12pt;">）使用一星期後無效者。</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十)外用皮膚藥 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鋅(Zinc Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿克利諾兒(Acrinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">苯甲酸鈉(Sodium Benzoate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">魚肝油(Cod Liver Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">苯甲酸(Benzoic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫黃(Sulfur)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼砂(Borax)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">紅汞(Mercurochrome)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">植物油(Vegetable Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">抗組織胺(Antihistamine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">龍膽紫(Gentiana Violet)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷油(Menthol Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">對氨基苯甲酸乙酯(Ethyl-P-Aminobenzoate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">冬綠油(Methyl Salicylate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">紫草(Lithospermum Erythrorhizon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當歸(Angelica)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">丁香油(Oleum Caryophylli)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮油(Oleum Cinnamomi)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">雷鎖辛(Resorcinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻油(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甲烯藍(Methylene Blue)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碘溶液(Iodine Solution)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碘化鉀(Pot Iodide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">濕疹、癩皮、膿、凍傷、創傷、汗疹、止痒。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十一)外用殺菌劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫黃(Sulfur)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">明礬(Alum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">3% </span><span style="font-family: 標楷體; font-size: 12pt;">雙氧水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2% </span><span style="font-family: 標楷體; font-size: 12pt;">紅汞水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">1% </span><span style="font-family: 標楷體; font-size: 12pt;">紫藥水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.5% </span><span style="font-family: 標楷體; font-size: 12pt;">稀碘酒 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">1% </span><span style="font-family: 標楷體; font-size: 12pt;">黃藥水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">以上包裝都60ml以下。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">外用殺菌、消毒。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十二)外用制汗劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">福馬林(Formalin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">明礬(Alum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鋅(Zinc Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷腦(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">醋酸鋁(Aluminum Acetate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">制汗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十三)硬膏劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸銅(Cup. Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">東莨菪浸膏(Ext Scopoliae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鉛(Lead Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">松脂(Resina Pini)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">疔、水泡、腫傷。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十四)脫毛劑 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">脫毛為目的之外用劑，劑型原則上軟膏劑)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫化鋇(Barium Sulfide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫化鈉(Sodium Sulfide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化鍶(Strontium Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化鉀(Potassium Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化鈉(Sodium Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫醇基乙酸鈉(Thioglycolate Sodium)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫化鈣(Calcium Sulfide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鋅(Zinc Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃軟石蠟(Petrolatum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白陶土(Kaolin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滑石粉(Talc)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澱粉(Starch), etc.</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">除毛 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十五)婦人科藥劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">鞣酸(Tannic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當歸(Angelica)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">芍藥(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">川芎(Cnidii Rhizoma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">地黃(Rehmanniae Rhizoma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白朮(Atractylodes Ovata)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澤瀉(Alisma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人參(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘草(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茯苓(Hoelen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">牡丹皮(Paeonia Moutan)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桃仁(Prunus Persica)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">貧血、赤白帶、月經不順、產前產後調養、頭痛、頭暈、下腹痛、安胎、月經困難、腰部塞冷、瘀血、更年期障害。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr style="height: 212.6pt;"> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; height: 212.6pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">十六)小兒科藥劑 </span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; height: 212.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茴香(Foeniculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大黃(Rheum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸鎂(Mag Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">牛黃(Benzoar Oriental)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蟾酥</span><span style="font-family: 標楷體; font-size: 12pt;">(Bufo Bufo)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">沉香</span><span style="font-family: 標楷體; font-size: 12pt;">(Aquilaria Agallocha)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人參(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乳酸菌(Lactobacteria)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滋養糖(Saccharum Amyl)</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 212.6pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">消化不良、綠便、小兒夜哭。 </span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; height: 212.6pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> </tbody> </table> </td> </tr> </tbody></table> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4489&type=0
1420463 藥政管理類,成藥及固有成方製劑管理辦法 法規命令 〈成藥及固有成方製劑管理辦法〉附件二 <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 18pt;">成藥及固有成方製劑管理辦法第二條附件二修正規定</span></b> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="727"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 545.4pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">劑別</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">主要成分</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">主要效能</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="text-fit: 139.5pt;"><b><span style="letter-spacing: 15.25pt; font-family: 標楷體;">其他規定</span></b></span><b> </b></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">一</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">清涼劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乙醚</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Ether)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯丁醇</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Chlorobutanol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蜂蜜</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Mel)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">葉綠素</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Chlorophyll)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿仙草</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">砂仁</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Amomum Xanthioides)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">豆蔻</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Elettaria Cardamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘草</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">小茴香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Foenlculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人參</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">木香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Inula Helenium)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">丁香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Caryophyllus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">龍腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Borneal)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">芍藥</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">山椒</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Xanthoxylum Piperitum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">生薑</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Zingiber)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">胃痛、嘔吐、口臭、清涼、中暑、吐瀉、暈車、暈船、腹痛。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">二</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">外用軟油膏類</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">多綠油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Methyl Salicylate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">丁香油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Eugenol)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">切傷、刀傷、創傷、火傷、蟲咬傷、頭暈。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">三</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">外用撒布劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Oleum Cassiae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白陶土</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Kaolin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鋅</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Zinc Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鎂</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Magnesium Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滑石粉</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Talc)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澱粉</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Starch)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Boric Acid)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">防止體臭、止癢、吸著、收歛。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">四</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">養毛髮劑</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">脫毛之防止、育毛為目的之外用劑，劑型原則上液劑為準</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">雷鎖辛</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Resorcinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">醇</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Alcohol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石炭酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Phenol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">薄荷腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">抗組織胺</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Antihistamine)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">育毛、薄毛、圓形脫毛症、止癢、預防脫毛、促進發毛、養毛、脂漏治療（皮脂漏）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">五</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">含藥酒類</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">&nbsp;</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（六）漱口水劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #111111; font-size: 12pt;">氯己定葡糖酸鹽氯己定葡糖酸鹽</span><span style="font-family: 新細明體; font-size: 12pt;">（</span><span style="font-family: times new roman,serif; font-size: 12pt;">Chlorhexidine Gluconate</span><span style="font-family: 新細明體; font-size: 12pt;">） </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">十六烷基氯化砒啶</span><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">（</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium Chloride</span><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">口腔內之殺菌、消毒、清潔、去除口臭。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">1.</span><span style="font-family: 標楷體; font-size: 12pt;">適用範圍：凡以口腔內之清潔殺菌等為目的，且成分含量符合本基準範圍而製成之漱口水劑均適用本基準。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.</span><span style="font-family: 標楷體; font-size: 12pt;">有效成分之種類含量及配合規則： </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 12pt;">（1）<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 12pt;">有效成分之種類含量： </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="328"> <tbody> <tr style="page-break-inside: avoid; height: 24.05pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 24.05pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center;"><span style="font-family: 標楷體;">有 效 成 分 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 24.05pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體;">含量範圍 (% w/v)</span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.55pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 26.55pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: 標楷體; color: #111111;">氯己定葡糖酸鹽氯己定葡糖酸鹽 </span></p> <p><span style="font-family: 新細明體,serif;">（</span>Chlorhexidine Gluconate<span style="font-family: 新細明體,serif;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 26.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">0.1 <span style="font-family: 新細明體,serif;">＜</span> <span style="font-family: 新細明體,serif;">≦</span> 0.2</p> </td> </tr> <tr style="page-break-inside: avoid; height: 27.8pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 27.8pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: 標楷體; color: #000000;">十六烷基氯化砒啶</span><span style="font-family: 標楷體; color: #000000;">（</span>Cetylpyridinium Chloride<span style="font-family: 標楷體; color: #000000;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 27.8pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">0.045 <span style="font-family: 新細明體,serif;">≦</span> <span style="font-family: 新細明體,serif;">≦</span> 0.1</p> </td> </tr> </tbody> </table> <p style="layout-grid-mode: char; punctuation-wrap: simple;">&nbsp;</p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 12pt;">（2）<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 12pt;">配合規則：限單方製劑。 </span></p> <ol> <li><span style="font-family: 標楷體; font-size: 12pt;">劑型：外用液劑。 </span></li> <li><span style="font-family: 標楷體; font-size: 12pt;">適應症：口腔內之殺菌、消毒、清潔、去除口臭。</span> </li> <li><span style="font-family: 標楷體; font-size: 12pt;">用法及用量：每次以適量之漱口水劑於口腔內漱洗並停留三十秒至六十秒後吐出，可於早晚或需要時使用。本類製劑須刊載具體使用方法及用量。</span> </li> <li><span style="font-family: 標楷體; font-size: 12pt;">注意事項：</span> </li> </ol> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（1） </span><span style="font-family: 標楷體; font-size: 12pt;">為防止兒童誤食請妥善保管。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（2） </span><span style="font-family: 標楷體; font-size: 12pt;">避免陽光直射，宜保存於陰涼之處。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（3） </span><span style="font-family: 標楷體; font-size: 12pt;">未滿六歲兒童不得使用，</span> <span style="font-family: 標楷體; font-size: 12pt;">六歲以上十二歲以下兒童需在大人指導下使用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（4） </span><span style="font-family: 標楷體; font-size: 12pt;">僅供漱洗，請勿吞服。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（5） </span><span style="font-family: 標楷體; font-size: 12pt;">本產品在正常使用下是安全的，但如有副作用的情形發生時（如灼熱感及刺痛感等），請立即停用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（6） </span><span style="font-family: 標楷體; font-size: 12pt;">含酒精之本類製劑，增列下述注意事項：本品含酒精</span><span style="font-family: times new roman,serif; font-size: 12pt;">○○%</span><span style="font-family: 標楷體; font-size: 12pt;">，宜審慎使用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（7） </span><span style="font-family: 標楷體; font-size: 12pt;">口腔潰瘍者，請勿使用含酒精成分之本類製劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（8） </span><span style="font-family: 標楷體; font-size: 12pt;">如不慎過量使用及吞服後，感覺不適者，請立即就醫。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（9） </span><span style="font-family: 標楷體; font-size: 12pt;">使用後三十分鐘內請勿進食、吸煙或服用飲料。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體;"><span style="font-size: 18px;">（10）</span><span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-family: 標楷體; font-size: 12pt;">含</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium chloride</span><span style="font-family: 標楷體; font-size: 12pt;">之本類製劑，增列下述注意事項：過度使用含</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium chloride</span><span style="font-family: 標楷體; font-size: 12pt;">漱口水劑可能使牙齒染色。</span> </p> </td> </tr> </tbody> </table> <p><span style="font-family: 標楷體;">備註：其他成份視其藥品安全性之程度由衛生署審定加減。</span> </p> </td> </tr> </tbody></table> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4490&type=0
1420464 化學製造管制類,藥物製造/委託製造,藥物委託製造及檢驗作業準則 法規命令 「藥物委託製造及檢驗作業準則」第八條、第十二條修正條文 詳如附件 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4491&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6070&type=0
1420465 臨床試驗類,藥品生體可用率及生體相等性試驗準則 法規命令 「藥品生體可用率及生體相等性試驗準則」附件+溶離相似性（f+2值）之計算方式及結果認定 <p class="null" style="margin: auto 0cm auto 33pt;"><span style="font-family: 新細明體;"><b><span style="font-size: 10pt; color: #333333;">附件　溶離相似性（</span></b><b><span style="font-size: 10pt; color: #333333;">f <sub>2</sub></span></b><b><span style="font-size: 10pt; color: #333333;">值）之計算方式及結果認定</span></b> </span></p><p class="null" style="text-align: center; margin: auto 0cm auto 33pt;"><span style="font-family: times new roman,serif; position: relative; color: #333333; top: 48pt;"></span></p><p class="null" style="margin: auto 0cm;"><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;"><br /><img alt="" src="../Files/NewsUpload/2.png" /><br /><br />上列公式</span><span style="font-size: 10pt; color: #333333;">f <sub>2</sub></span><span style="font-size: 10pt; color: #333333;">溶離相似值，</span><span style="font-size: 10pt; color: #333333;">n</span><span style="font-size: 10pt; color: #333333;">為溶出之採樣點數，</span></span><span style="font-size: 10pt; font-family: 標楷體; position: relative; color: #333333; top: 5pt;"> </span><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;">係對照藥品於</span><span style="font-size: 10pt; color: #333333;">t</span><span style="font-size: 10pt; color: #333333;">時間點之平均溶出百分比，</span></span><span style="font-size: 10pt; font-family: 標楷體; position: relative; color: #333333; top: 5pt;"> </span><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;">係受試藥品於</span><span style="font-size: 10pt; color: #333333;">t</span><span style="font-size: 10pt; color: #333333;">時間點之平均溶出百分比。</span> </span></p><p class="null" style="margin: auto 0cm;"><span style="font-size: 10pt; font-family: 新細明體; color: #333333;">In this equation <i>f</i> <sub>2</sub> is the similarity factor, n is the number of time points,</span><span style="font-size: 10pt; font-family: 標楷體; color: #333333;"> &nbsp;</span><span style="font-size: 10pt; color: #333333;"><span style="font-family: 新細明體;">is the mean percent drug dissolved of e.g. a reference product, and </span><span style="position: relative; top: 5pt;"></span><span style="font-family: 新細明體;">&nbsp;is the mean percent drug dissolved of e.g. a test product.</span></span> </p><p class="null" style="margin: auto 0cm;"><span style="font-size: 10pt; font-family: 新細明體; color: #333333;">&nbsp; </span></p><p class="null" style="margin: auto 0cm;"><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;">f <sub>2</sub></span><span style="font-size: 10pt; color: #333333;">值≧</span><span style="font-size: 10pt; color: #333333;">50</span><span style="font-size: 10pt; color: #333333;">，為認定受試藥品及對照藥品溶離曲線比對相似之必要條件。</span> </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6090&type=0
1420466 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件一藥品製劑包裝限量表 <p><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">附件一</span></b> </p><p><b><span style="font-size: 10pt; color: #333333;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></b><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">藥品製劑包裝限量表</span></b> </p><table width="607" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">劑型</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">類別</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">單位包裝最大限量</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">錠劑、丸劑、膠囊劑、口含錠、舌下錠</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥品</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一千錠以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">五百錠以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">口服液</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師藥師藥劑生指示藥品或成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">均以一次用完為限且不得超過一百毫升</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">注射劑</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">限由醫師使用</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">注射瓶裝或安瓿（</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">Vial or Ampoule</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">）均以每盒一百支以下（溶劑不在內）</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">滴眼、鼻、耳劑、噴鼻、耳、喉劑</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方、醫師藥師藥劑生指示藥品、成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百毫升以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="3"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">軟膏劑</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥品</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">不含抗生素</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一千公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">含抗生素</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">栓劑</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方、醫師藥師藥劑生指示藥品、成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百顆以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">粉、顆粒劑（原料藥不在此限）</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥品</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一千公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">五百公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="3"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">液劑、酊劑、酏劑、醑劑、擦劑、糖漿劑、懸液劑、乳劑（原料藥不在此限）</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥品</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">不含抗生素</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">四千毫升以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">含抗生素</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一千毫升以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">成藥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">五百毫升以下</span> </p> </td> </tr> </tbody></table><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">註１、</span><span style="font-size: 10pt; color: #333333;">&nbsp; </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">藥品許可證包裝欄所載數量，如超過藥品製劑包裝限量標準，惟曾經中央衛生主管機關核定有案者，得繼續使用，無需更改。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">２、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">藥品包裝凡符合限量規定者，廠商得配合市場上需要，自行調整，免申請變更登記。但超過限量規定之包裝，仍應依規定檢附醫療機構或學術團體訂購證明，申請變更登記。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">３、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一般製劑之最小包裝，以成人二日最小用量為準。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">４、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">液體製劑，不得以易開罐瓶裝。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">５、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">口服液劑以成人一次劑量不須量取即供患者一次服用，並其單位包裝劑量限一百毫升以下。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">６、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">腹膜透析液之單位包裝最大限量為五千毫升以下。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">７、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">懸液劑及凝膠劑之鋁箔或塑膠袋裝，以一次量包裝為原則。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">８、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">注射劑如附有輸液套或輸注器，應於包裝欄填明，並依規定檢送輸液套或輸注器四十份及其檢驗規格備驗，如該輸注套輸注器已領有許可證者，得註明許可證字號，免予檢驗。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">９、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">全靜脈營養劑之單位包裝最大限量為一千四百毫升以下。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１０、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">製劑原料最小包裝為零點五公斤。但用量甚微者，以製造一批十萬粒，注射劑一萬支，軟膏一萬支，或十萬公克之用量為其最小包裝。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１１、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">洗眼劑之單位包裝最大限量為五百毫升以下。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１２、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">含可待因（磷酸鹽）糖漿劑指示藥品最大單位包裝不得超過三日用量。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１３、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">含麻黃素或假麻黃素之錠劑及膠囊劑，其包裝材質以鋁箔盒裝為限，如類別屬指示藥品者，其最大包裝量並以成人七日用量為限，且不適用本表註１及註２之規定。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１４、</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">感冒、解熱鎮痛、咳嗽液劑，其包裝限量為成人一次量至四千毫升。</span> </p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6100&type=0
1420467 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件二新藥及新劑型、新使用劑量、新單位含量製劑查驗登記應檢附資料表 <p style="layout-grid-mode: char; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">附件二</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體; color: #000000;">新藥及新劑型、新使用劑量、新單位含量製劑查驗登記應檢附資料表</span> </p><table width="99%" style="border-collapse: collapse; margin: auto auto auto 1.4pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 182.1pt; page-break-inside: avoid;"> <td valign="top" style="height: 182.1pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent;border: windowtext 1pt solid;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">應檢送資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">規費 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">藥品查驗登記申請書正 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">副本 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">切結書甲 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">乙 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">標籤仿單黏貼表二份 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">證照黏貼表 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">委託書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">出產國許可製售證明 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; color: #000000;">*1</span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">處方依據或處方設計研究</span><span style="font-size: 10pt; color: #000000;">*2</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">符合藥品優良製造規範之證明文件影本</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">有效成分檢驗規格 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、方法及檢驗成績書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">賦形劑檢驗規格、 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">方法及檢驗成績書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">成品檢驗規格 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、方 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">法及檢驗成績書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">製造管制標準書或批次製造紀錄 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">分析方法確效資料二份 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">關鍵性製程確效資料二份 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; color: #000000;">*3</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">採用證明 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">送 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">驗 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; color: #000000;">*4</span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">技 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">術 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">性 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">資 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">料 </span></p> </td> </tr> <tr style="height: 15.3pt; page-break-inside: avoid;"> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 4.1%; background-color: transparent;" rowspan="12"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新</span> </p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">藥</span> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新成分 </span></p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.42%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="21"> <p style="margin: 0cm -1.3pt 0pt 0cm; line-height: 13pt;"><span style="font-size: 24px; font-family: 標楷體;">&nbsp;</span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">依 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">附 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">件 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">三 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">之 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">規 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">定 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">檢 </span></p> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">附 </span></p> </td> </tr> <tr style="height: 9.85pt; page-break-inside: avoid;"> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 7.2pt; page-break-inside: avoid;"> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新使用途徑 </span></p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新療效 </span></p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新複方 </span></p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 4.1%; background-color: transparent;" rowspan="9"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">劑</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">型</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">使</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">用</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">劑</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">量</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">單</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">位</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">含</span> </p> <p style="layout-grid-mode: char; text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">量</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新劑型 </span></p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新使用劑量 </span></p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新單位含量 </span></p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;">&nbsp;</p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> </tbody></table><p style="layout-grid-mode: char; text-align: justify; margin: 9pt 0cm 0pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註：○ 表示須檢附該項目之資料。 　╳ 表示不須檢附該項目之資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*1</span><span style="font-size: 10pt; font-family: 標楷體;">如出產國許可製售證明中未刊載完整之製造廠址者，應另檢送最近一次GMP查廠報告憑核。（如僅未刊載郵遞區號或區者，得以原廠函說明） </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*2</span><span style="font-size: 10pt; font-family: 標楷體;">由國內自行研發之新藥、新劑型、新使用劑量、新單位含量製劑，免附處方依據。但應另附處方設計研究。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*3</span><span style="font-size: 10pt; font-family: 標楷體;">申請輸入藥品查驗登記，如係無菌製劑產品者，其關鍵性製程確效應含滅菌確效資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*4</span><span style="font-size: 10pt; font-family: 標楷體;">依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品。</span> </p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6099&type=0
1420468 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件三新藥及新劑型、新使用劑量、新單位含量製劑查驗登記應檢附之技術性資料表 <p><span style="font-size: 10pt; font-family: 標楷體;">附件三</span> </p><p style="text-align: center;"><span style="font-family: 標楷體;">新藥及新劑型、新使用劑量、新單位含量製劑查驗登記應檢附之技術性資料表</span> </p><table width="100%" style="border-collapse: collapse; width: 100%;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: center; margin: 3.6pt 0cm; line-height: 13pt;">&nbsp;</p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;">&nbsp;</p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.38%; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">起源、發現經過、 國外使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.1%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">物化 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">性質 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 31.36%; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">安 全 性 試 驗 報 告 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.6%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">藥理作用 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 11.58%; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">吸收、分佈 </span></p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">、代謝、排泄</span><span style="font-size: 10pt; font-family: 標楷體;">試驗報</span> </p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">告（動物</span><span style="font-size: 10pt;">/</span><span style="font-size: 10pt; font-family: 標楷體;">人）</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 13.16%; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">&nbsp;</span><span style="font-size: 10pt; font-family: 標楷體;">臨床試驗 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">報告 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;">&nbsp;</p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">起源發現經過 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">國外使用情形 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">性質比較 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">構造式 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">物理化學性質 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">急性毒性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">亞急性毒性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">慢性毒性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">胚胎試驗 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">依賴性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">抗原性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">致突變性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">致癌性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">局部刺激性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">有效性證明 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">一般藥理 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">吸收 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">分佈 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">代謝 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">排泄 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">生體可用率 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">生體相等性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">其他</span><span style="font-size: 10pt; font-family: 標楷體;">臨床試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">醫藥期刊 </span></p> </td> </tr> <tr style="height: 15.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 3.32%; background-color: transparent;" rowspan="12"> <p style="margin: 3.6pt 0cm; line-height: 13pt;">&nbsp;</p> <p style="margin: 3.6pt 0cm; line-height: 13pt;">&nbsp;</p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新 </span></p> <p style="margin: 3.6pt 0cm; line-height: 13pt;">&nbsp;</p> <p style="margin: 3.6pt 0cm; line-height: 13pt;">&nbsp;</p> <p style="margin: 3.6pt 0cm; line-height: 13pt;">&nbsp;</p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">藥 </span></p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新成分 </span></p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="height: 19.8pt; page-break-inside: avoid;"> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="height: 7.2pt; page-break-inside: avoid;"> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新使用途徑 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新療效 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> </tr> <tr style="height: 3.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新複方 </span></p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 3.32%; background-color: transparent;" rowspan="10"> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">新 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">劑 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">型 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">、 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">新 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">使 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">用 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">劑 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">量 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">、 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">新 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">單 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">位 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">含 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm 3.6pt -1.2pt; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">量 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新劑型 </span></p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">(</span><span style="font-size: 10pt; font-family: 標楷體;">控釋)</span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新劑型 </span></p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">(</span><span style="font-size: 10pt; font-family: 標楷體;">速放)</span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新使用劑量 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新單位含量 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮吸收劑型</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">◎ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> </tr> </tbody></table><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">註：○ 表示須檢附該項目之資料。&nbsp;&nbsp; ╳ 表示不須檢附該項目之資料。&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">△ </span><span style="font-size: 10pt; font-family: 標楷體;">表示視個案而定。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">◎表示依下述方法擇一辦理：（1）生體相等性試驗。（2）生體可用率及臨床試驗。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">一、申請之藥品如有療效或安全之顧慮者，應依中央衛生主管機關要求，另檢送相關資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">二、其他臨床試驗報告應依中央衛生主管機關公告事項規定辦理。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">三、新單位含量如屬非監視新藥成分者，得免附生體相等性試驗，或生體可用率及臨床試驗資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">四、醫藥期刊係指臨床文獻報告。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">五、「國外使用情形」乙項，如係國內自行研發者，免附。 </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6098&type=0
1420469 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件四學名藥查驗登記應檢附資料表 - 複製 <p style="layout-grid-mode: char; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">附件四</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">學名<span style="color: #000000;">藥查驗登記應檢附資料表</span></span> </p><div style="text-align: center;"><table width="624" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 11.4pt; page-break-inside: avoid;"> <td style="border-top: windowtext 1pt solid; height: 11.4pt; border-right: black 1pt solid; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;" rowspan="3"> <p style="layout-grid-mode: char; text-align: justify; text-justify: distribute-all-lines; -11: ;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">應檢送資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 11.4pt; border-right: windowtext 1pt solid; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 261.8pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="8"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">學　　　　　　　　名　　　　　　　　　　藥 </span></p> </td> </tr> <tr style="height: 6.15pt; page-break-inside: avoid;"> <td style="height: 6.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">監視藥品(含監視期間及監視期滿藥品)</span></p> </td> <td style="height: 6.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">一般學名藥 </span></p> </td> <td style="height: 6.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81.8pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">醫用氣體</span> </p> </td> </tr> <tr style="height: 10.15pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">規費 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">藥品查驗登記申請書正、副本 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">切結書（甲） </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">切結書（乙） </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">仿單標籤黏貼表二份 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">證照黏貼表 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 7.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">製造管制標準書（包括批次紀錄中之下料量）或批次製造紀錄 </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">有效成分檢驗規格與方法及成績書 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">賦形劑檢驗規格與方法及成績書 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">成品檢驗規格與方法及成績書 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 8.95pt; page-break-inside: avoid;"> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△ </span></p> </td> </tr> <tr style="height: 10.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">符合藥品優良製造規範之證明文件影本 </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">出產國許可製售證明 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 10.6pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">委託書 </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> </tr> <tr style="height: 5.65pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">分析方法確效資料 </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> </tr> <tr style="height: 8.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">關鍵性製程確效資料 </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">○<sup>＊1</sup> </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">臨床試驗、生體可用率試驗、生體相等性試驗 </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋＋ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋＋ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">送驗＊2</span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> </tr> <tr> <td style="width: 275px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 16px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 43px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 7px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 51px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> </tr> </tbody></table></div><p style="layout-grid-mode: char; text-align: justify; margin: 9pt 0cm 0pt 20pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">註：○：表示須檢附該項目之資料。　╳：表示不須檢附該項目之資料。　</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△：</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">表示視個案而定。　 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 43.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt;">*1</span><span style="font-size: 10pt; font-family: 標楷體;">：表示應另依中央衛生主管機關相關公告規定辦理。</span> </p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 43.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt;">*2</span><span style="font-size: 10pt; font-family: 標楷體;">：</span><span style="font-size: 10pt; font-family: 標楷體;">依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品。</span> </p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 40.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＋：監視藥品之學名藥，監視期間內應檢附與以新藥提出查驗登記申請且取得許可證之廠商相同標準之國內臨床試驗報告</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">（含銜接性試驗）；如前述新藥於查驗登記核准時未檢送國內臨床試驗報告（含銜接性試驗）者，則其學名藥應檢送（1）生體相等</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">性試驗報告，或（2）生體可用率及臨床試驗報告。</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">監視期滿藥品，應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">＋＋：一般學名藥如係控釋劑型製劑或屬中央衛生主管機關公告須執行生體相等性試驗之品目者，應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">一、國產管制藥品查驗登記應另檢附管制藥品原料申請核准證明或挪用證明。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 41.3pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">二、安定性試驗資料包括書面作業程序、試驗報告、指標之定量分析方法及其方法之驗證等各一份。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">三、申請輸入藥品查驗登記，如係無菌製劑產品者，其關鍵性製程確效應含滅菌確效資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">四、委託製造或檢驗者，應附委託製造或檢驗契約書。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 41.3pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">五、醫用氣體係指供醫療用且含量各為百分之九十九．○v/v以上之二氧化碳（CO<sub>2</sub>）、氧氣（O<sub>2</sub>）及氧化亞氮（N<sub>2</sub>O）等三品項，其中二氧化碳（CO<sub>2</sub>）及氧氣（O<sub>2</sub>）之製造方法係源自大氣分離者，得免附安定性試驗資料，惟須留廠備查。 </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6097&type=0
1420470 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件五微脂粒（Liposome）及經皮吸收劑型學名藥查驗登記應檢附之技術性資料表 <p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: #000000;">附件五</span><span style="color: #000000;">&nbsp; </span><span style="font-family: 新細明體,serif; color: #000000;">微脂粒（</span><span style="color: #000000;">Liposome</span><span style="font-family: 新細明體,serif; color: #000000;">）</span><span style="font-family: 新細明體,serif; color: #000000; letter-spacing: -0.2pt;">及經皮吸收劑型學名藥查驗登記應檢附之技術性資料表</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;"> </span></p><table style="border-collapse: collapse; margin: auto auto auto 0.7pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent;border: windowtext 1pt solid;"> <p>&nbsp; </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p class="null" style="text-align: center;"><span style="font-family: 新細明體;">起源、發現、經過、國外使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">物化</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">性質</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">安</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">全</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">性</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">試</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">驗</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">報</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">告</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">藥理</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">作用</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">吸收、分佈、代謝、排泄</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">試驗報告</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">（動物</span><span style="font-size: 11pt;">/</span><span style="font-size: 11pt; font-family: 新細明體,serif;">人）</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">臨床試驗</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">報告</span> </p> </td> </tr> <tr> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p>&nbsp; </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">起源發現經過</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">國外使用情形</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">性質比較</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">構造式</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">物理化學性質</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">急性</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">亞急性毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">慢性毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">胚胎試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">依賴性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">抗原性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">致突變性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">致癌性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">局部刺激性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">有效性證明</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">一般藥理</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">吸收</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">分佈</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">代謝</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">排泄</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">生體可用率</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">生體相等性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">其他臨床試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">醫藥期刊</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">Liposome </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">學名藥(i) </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">學名藥(ii) </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">經皮吸收劑型</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;">&nbsp; </p> </td> </tr> <tr style="height: 7.2pt;"> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">學名藥</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> </tbody></table><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">註：○表示須檢附該項目之資料。╳表示不須檢附該項目之資料。△表示視個案而定。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">◎表示依下述方法擇一辦理：</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(1)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">生體相等性試驗。</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(2)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">生體可用率及臨床試驗。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">學名藥</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(i)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">：主成分相同，但賦形劑成分及其比例不同之學名藥。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">學名藥</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(ii)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">：主成分、賦形劑成分及其比例皆相同之學名藥。 </span></p><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">一、所申請藥品如有療效或安全之顧慮者，應依中央衛生主管機關要求，另檢送相關資料。 </span></p><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">二、其他臨床試驗報告應依中央衛生主管機關公告之規定辦理。 </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6096&type=0
1420471 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件六生物藥品查驗登記應檢附資料表 <p style="layout-grid-mode: char; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">附件六</span> </p><p style="layout-grid-mode: char; text-align: center; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">生物藥品查驗登記應檢附資料表</span> </p><table width="722" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 10.85pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.85pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">應檢送資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">基因工程藥品（含生物相似性藥品）</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊3</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">疫苗類藥品 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">人用血漿藥品 </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">過敏原藥品 </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 0cm -41.75pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">其他類 </span></p> </td> </tr> <tr style="height: 6.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">規費 </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">藥品查驗登記申請書正、副本 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 6.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">切結書（甲） </span></p> </td> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 10.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">切結書（乙） </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">仿單標籤黏貼表二份 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; 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border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">批次製造紀錄 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">有效成分檢驗規格與方法及成績書二份 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">賦形劑檢驗規格與方法及成績書二份 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">成品檢驗規格與方法及成績書二份 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">安定性試驗書面作業程序及其檢驗報告 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">採用證明＊1</span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">出產國許可製售證明（輸入）、處方依據（國產） </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 10.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">委託書（輸入藥品） </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 5.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">符合藥品優良製造規範之證明文件影本 </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 9.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">分析方法確效資料二份 </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 5.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">關鍵性製程確效資料二份＊2</span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○<b> </b></span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 19.15pt; page-break-inside: avoid;"> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">製程中所使用動物原料之原廠動物原料來源管制之標準作業程序及原料來源證明，或原廠出具於製程中未使用動物成分來源之證明 </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 10.55pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">送驗</span><span style="font-size: 10pt; layout-grid-mode: line;">＊4</span> </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line;">╳ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> </tr> <tr style="height: 6.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">技術性資料 </span></p> </td> <td valign="top" style="height: 6.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 324pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="5"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">依　　附　　 件　　七　　之　　規　　定　　檢　　附 </span></p> </td> </tr> </tbody></table><p style="margin: 9pt -1.3pt 0pt 0cm; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">註：○表示須檢附該項目之資料。　　　△表示視個案而定。　　　Ｘ表示不須檢附。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊1採用證明之相關規定如下： </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 39.2pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">屬基因工程藥品（含生物相似性藥品）、疫苗類藥品、人用血漿藥品與過敏原藥品等四類生物藥品： </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">一、如出產國屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，且已有類似（同來源、同成分）產品上市，則其出產國許可製售證明得替代採用證明。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">二、如出產國屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，但無類似（同來源、同成分）產品上市，則領證前除應有出產國許可製售證明外，應有另一十大醫藥先進國之採用證明。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">三、如出產國非屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，但已有類似（同來源、同成分）產品上市，則領證前除應有出產國許可製售證明外，應有另一十大醫藥先進國之採用證明。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">四、如出產國非屬美、日、加拿大、澳洲、英國（第一組）及德、法、瑞典、瑞士、比利時（第二組）等十國中之一國，且無類似（同來源、同成分）產品上市，則領證前除應有出產國許可製售證明外，應依現行規定補齊三國採用證明（即二組中各一國之採用證明或十國中之三國採用證明）。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊2申請輸入藥品查驗登記，如係無菌製劑產品者，其關鍵性製程確效應含滅菌確效資料。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊3生物相似性藥品：指以生物技術衍生之生物藥品，於品質、安全及功效上，與原本作為參考並已獲得我國上市許可之生物藥品相似。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊4過敏原藥品，依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品。 </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6095&type=0
1420472 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件七生物藥品查驗登記應檢附之技術性資料表 <p style="layout-grid-mode: char; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">附件七</span> </p><p style="layout-grid-mode: char; text-align: center; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">生物藥品查驗登記應檢附之技術性資料表</span> </p><table width="100%" style="border-collapse: collapse; width: 100%;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6%; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="margin: 1pt 0cm;">&nbsp;</p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 10.1%; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">起源、發現經過、國外使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 10.44%; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">物化性質、檢驗方法、規格 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">安定性試驗報告 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 37.28%; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">非 臨 床 之 安 全 性 試 驗 報 告 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.78%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">藥理 </span></p> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">作用 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 17.36%; background-color: transparent; border-left-color: #f0f0f0;" colspan="6"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">吸收、分佈、代謝、排泄、生體可用率／生體相等性試驗報告 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.78%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">臨床試驗報告 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">其 他 資 料 </span></p> </td> </tr> <tr style="height: 73.55pt; page-break-inside: avoid;"> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">起源發現經過 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國外使用情形 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">性質比較 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">構造式 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">物理化學性質 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">檢驗規格方法 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;">&nbsp;</p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">單一劑量毒性 </span></p> </td> <td valign="top" style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">﹙三個月﹚ </span></p> <p style="layout-grid-mode: char; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">重覆劑量毒性 </span></p> </td> <td valign="top" style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">﹙六個月﹚ </span></p> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">重覆劑量毒性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">生殖毒性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">依賴性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">抗原性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">基因毒性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">致癌性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">局部刺激性 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">有效性證明 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">一般藥理 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">吸收 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">分佈 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">代謝 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">排泄 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">生體可用率 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">生體相等性 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">臨床試驗 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">醫學期刊 </span></p> </td> </tr> <tr style="height: 8.15pt;"> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">基因工程藥品 </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註1</span></p> </td> </tr> <tr style="height: 12.15pt;"> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">生物相似性藥品 </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註1</span></p> </td> </tr> <tr style="height: 8.45pt;"> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">疫苗類藥品 </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註2</span></p> </td> </tr> <tr style="height: 11.55pt;"> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">人用血漿藥品 </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註3</span></p> </td> </tr> <tr style="height: 7.55pt;"> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">過敏原藥品 </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">---</span></p> </td> </tr> <tr style="height: 12.85pt;"> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">其他類 </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">△ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">○ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">---</span></p> </td> </tr> </tbody></table><p><span style="font-size: 10pt; font-family: 標楷體;">○表示須檢附該項目之資料。 &nbsp;&nbsp;&nbsp;△表示視個案而定。&nbsp;&nbsp; Ｘ表示不須檢附該項目之資料。 </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">註１：基因工程藥品（含生物相似性藥品）應檢附攜帶表現基因之載體構造與特性，宿主之特性，MCB（Master Cell Bank</span></p><p><span style="font-size: 10pt; font-family: 標楷體;">）與MWCB（Manufacture Working Cell Bank）之敘述及載體之安定性，產品收穫及純化過程。 </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">註２：疫苗類藥品之製造管制，應符合種源批次系統（Seed Lot System），並包括在分裝前之製造過程各階段均適時取樣， </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">完成分裝前之各項試驗，含種菌（seed strain）、Master Seed Lot, Manufacturing Working Cell Bank（MWCB）、培養基（Cell Culture Medium）、醱酵（培養）產物、純化後產物、分裝前溶液及最終產品等各階段之試驗項目，另純化之方法亦應詳述。 </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">註３：人用血漿藥品應檢具血漿原料來源清單、血漿原料規格（每一血袋須作Ｂ型肝炎表面抗原、Ｃ型肝炎抗體及人類免疫缺乏病毒第Ⅰ型及第Ⅱ型抗體篩檢），並檢附病毒去活化或去除步驟之確效資料。血漿混合液（Plasma pool）應有以核酸擴增技術（Nucleic acid amplification technology; NAT）檢測，至少應有對HCV、HIV及HBV之病毒核酸之NAT檢驗為陰性之結果報告，若NAT檢測方法尚未於我國取得許可證，申請廠商應將其檢驗規格、方法及靈敏度等，依其他類查驗登記之要求，檢附相關資料供審查評估，且中央衛生主管機關將參考其他國家之規定，公告新增之篩檢項目及要求。另製造管制資料，應包括分裝前之製造過程各階段適時取樣，完成分裝前之各項試驗，包括單一血袋血漿、混合血漿、純化後產物、分裝前溶液及最終產品等各階段之試驗項目。 </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6094&type=0
1420473 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件八原料藥查驗登記應檢附資料表 - 複製 <p style="layout-grid-mode: char; text-align: justify; margin: 0cm 0cm 12.5pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">附件八</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 12.5pt; line-height: 12pt;"><span style="font-family: 標楷體;">原料藥查驗登記應檢附資料表</span> </p><div style="text-align: center;"><table width="582" style="border-collapse: collapse; margin: auto auto auto -65.75pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 33.15pt; page-break-inside: avoid;"> <td style="height: 33.15pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 8cm; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: justify; text-justify: inter-ideograph; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">應檢附資料</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 33.15pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; line-height: 14pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">一般原料藥</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 33.15pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 139.7pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 14pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用原料藥</span> </p> </td> </tr> <tr style="height: 33.2pt; page-break-inside: avoid;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">非臨櫃 </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">臨櫃<sup>*3</sup> </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">規費</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">藥品查驗登記申請書正本、副本</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">切結書（甲）、切結書（乙）</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用切結書</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用原料藥臨櫃查驗登記申請切結書</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">仿單標籤黏貼表二份</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">證照黏貼表</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">△<sup>*4</sup> </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">近二年內查核符合原料藥</span><span style="font-size: 10pt;">GMP</span><span style="font-size: 10pt; font-family: 標楷體;">之證明影本</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">△ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">委託書（輸入藥品）</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">出產國許可製售證明（輸入藥品）</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">技術性資料</span><sup><span style="font-size: 10pt;">*1</span></sup><sup> </sup></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○<sup>*2</sup> </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○<sup>*2</sup> </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">○<sup>*2</sup> </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">送驗</span><sup><span style="font-size: 10pt;">*5</span></sup> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> </tbody></table></div><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 18pt;">&nbsp;</p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">○ 表示須檢附該項目之資料。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">△ 表示視個案而定。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">╳：表示不須檢附該項目之資料。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*1 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">參見「原料藥查驗登記應檢附之技術性資料表」。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*2 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">應檢附技術性資料之份數，原則上，一般原料藥為十四份、外銷專用者為二份。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*3 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">限申請日前二年內，經查核符合原料藥廠GMP者。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*4 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">如已領有原料藥許可證，且許可證尚在有效期限內者，得免附。 </span></p><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*5 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品</span> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6093&type=0
1420474 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件九原料藥查驗登記應檢附之技術性資料表 <p><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">附件九</span></b> </p><p><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">　　　　　　　　　　　　　原料藥查驗登記應檢附之技術性資料表</span></b> </p><table width="607" style="border-collapse: collapse; width: 454.95pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 225pt; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp; </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一般原料藥</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 148.95pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">外銷專用原料藥</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">非臨櫃</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">臨櫃</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">外銷專用原料藥查驗登記臨櫃申請資料查檢表</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">技術資料工廠相關組織及人員</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">△</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp;</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">成品背景資料及製造方法依據</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">△</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp;</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">製造管制資料</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">△</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp;</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">規格、檢驗設備、檢驗方法與檢驗紀錄</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp;</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">△</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*3</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">安定性試驗資料</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">△</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp;</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">○</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*1</span></sup> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">&nbsp;</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> </tbody></table><p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">註：○表示須檢附該項目之資料。△表示視個案而定。╳：表示不須檢附該項目之資料。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">同意於領證後三個月內，補齊三個月</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">40℃</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">之加速安定性試驗資料，其餘安定性試驗資料，留廠備查。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">送件申請時，得免檢附，但相關資料應留廠備查。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">送件申請時，除應檢送檢驗規格與方法及成績書外，其餘資料得免檢附，但應留廠備查。</span> </p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6092&type=0
1420475 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件十核醫放射性藥品查驗登記應檢附資料表 <p style="layout-grid-mode: char; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: #000000;">附件十</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: #000000;">核醫放射性藥品查驗登記應檢附資料表</span> </p><table width="99%" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.86%; background-color: transparent;border: windowtext 1pt solid;" colspan="2"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">應檢送資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">規費 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">藥品查驗登記申請書正 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">副 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">本 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">切結書甲 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">乙 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">標籤仿單黏貼表二份 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">證照黏貼表 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">委託書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">出產國許可製售證明</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">1</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">處方依據</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">2</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">符合藥品優良製造規範之證明文件影本</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">有效成分檢驗規格 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、方法及檢驗成績書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">賦形劑檢驗規格、 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">方法及檢驗成績書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">成品檢驗規格 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、方法及檢驗成績書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">製造管制標準書或批次製造紀錄 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">分析方法確效資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">關鍵性製程確效資料</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">3</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">採用證明</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">4</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">送驗</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">5</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">技 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">術 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">性 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">資 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">料 </span></p> </td> </tr> <tr style="height: 19.45pt; page-break-inside: avoid;"> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">新藥</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.34%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="6"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">依 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">附 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">件 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">十 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">一 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">之 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">規 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">定 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">檢 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">附</span> </p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">新劑型</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.45pt; page-break-inside: avoid;"> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">新劑量</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">學名藥</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.34%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; line-height: 12pt;">&nbsp;</p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">6</span> </p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">○</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> </tbody></table><p style="layout-grid-mode: char; margin: 9pt 0cm 0pt; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註：○ 表示須檢附該項目之資料。&nbsp; ╳ 表示不須檢附該項目之資料。&nbsp; </span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*1 </span><span style="font-size: 10pt;">如出產國許可製售證明中未刊載完整之製造廠址者，應另附最近一次GMP查廠報告憑核</span><span style="font-size: 10pt;">。（如僅未刊載郵遞區號或區者，得以原廠函說明） </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*2 </span><span style="font-size: 10pt;">由國內自行研發之核醫放射性藥品新藥、新劑型、新劑量，免附處方依據。但應另附處方設計研究及該藥品之技術性資料。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*3 </span><span style="font-size: 10pt;">申請輸入藥品查驗登記，如係無菌製劑產品者，其關鍵性製程確效應含滅菌確效資料。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*4 </span><span style="font-size: 10pt;">國產之核醫放射性藥品新藥、新劑型、新使用劑量、新單位含量製劑，均應檢附處方設計研究。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*5 </span><span style="font-size: 10pt;">依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*6</span><span style="font-size: 10pt;">監視藥品之學名藥，監視期間內應檢附與以新藥提出查驗登記申請且取得許可證之廠商相同標準之國內臨床試驗報告（含銜接性試驗）；如前述新藥於查驗登記核准時未檢送國內臨床試驗報告（含銜接性試驗）者，則其學名藥應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。監視期滿藥品，應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。 </span></span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6091&type=0
1420476 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 法規命令 「藥品查驗登記審查準則」附件十一核醫放射性藥品新藥、新劑型、新劑量查驗登記應檢附之技術性資料表 <p style="margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: black;">附件十一 </span></p><p style="text-align: center; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: black;">核醫放射性藥品新藥、新劑型、新劑量查驗登記應檢附之技術性資料表 </span></p><table style="width: 100%; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 4.12%; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="7"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">申請核醫新藥查驗登記應檢附資料 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">文件 </span></p> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">類別 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">起源發現之經過及使用情形 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 23.36%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2" colspan="4"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">物理性質及化學性質之檢驗方法及檢驗規格 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 44.02%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="9"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">非臨床動物試驗報告 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 7.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">臨床試驗報告(應裝訂成冊並附摘要乙份)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">輻射劑量學報告 </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 23.64%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">安全性試驗報告 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 7.68%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">藥效試驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 12.68%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">藥動試驗 </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 102.95pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">藥品資料/新藥類別 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 9.06%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">性質及與其他藥品比較 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">外國使用情形 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">起源發現經過 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">構造式 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">物理化學性質 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">檢 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">規 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">格 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">及 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">方 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">法 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">含量均一度試驗 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">溶離試驗 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">或提供對照標準品 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">提供新成份之原料藥品 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">單 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">一 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">量 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">毒 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">性 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">重 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">覆 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">量 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">毒 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">性 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">抗原性試驗 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 9.06%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">局部刺激性試驗 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">致突變性、致癌性試驗 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">胚胎試驗、依賴性試驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">輻 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">射 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">生 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">物 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">證 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">明 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">有 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">效 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">之 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">一 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">般 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">藥 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">理 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">代謝、排泄、 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">吸收、分佈、 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">生體相等性試驗 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">生體可用率試驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; margin: 0cm 0.85pt 0pt 0cm; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">臨床試驗之設計及結果 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; margin: 0cm 0.85pt 0pt 0cm; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">研究文獻之回顧及出處 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;">&nbsp;</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.1%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新成分 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">診斷用 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">治療用 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新使用途徑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 15.75pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新適應症 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 105.15pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.12%; padding-right: 1.4pt; height: 105.15pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">核 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">醫 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">新 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">型 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">、 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">新 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">量 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">查 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">驗 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">登 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">記 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">應 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">檢 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">附 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">資 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">料</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新劑型 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 105.2pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新劑量 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">△ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">○ </span></p> </td> </tr> </tbody></table><p style="margin: 9pt 0cm 0pt;"><span style="font-family: 標楷體; color: black; font-size: 10pt;">○：表示須檢附該項目之資料。&nbsp; ╳：表示不須檢附該項目之資料。 △：表示視個案而檢附該項目之資料。 </span></p> 2013-12-03
1420477 化學製造管制類,藥品優良製造,藥物優良製造證明書申請辦法 法規命令 藥物優良製造證明書申請辦法 <p style="layout-grid-mode: char; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體;">第一條　　本辦法依藥事法第五十七條第五項規定訂定之。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第二條　　藥物優良製造證明書之申請程序、發給條件及應遵行事項， </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">依本辦法之規定；本辦法未規定者，依其他有關法令之規定。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第三條　　依藥物製造工廠設廠標準第三條第二項或第三項規定而</span><span style="font-size: 14pt; font-family: 標楷體;">取得 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">符合藥品優良製造規範或醫療器材優良製造規範證明文件之藥商 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">，得繳納費用並填具申請書表及相關資料，向中央衛生主管機關 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">申領證明書。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第四條　　前條證明書核發後</span><span style="font-size: 14pt; font-family: 標楷體;">，如經主管機關後續檢查發現有不符合藥 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">品優良製造規範或醫療器材優良製造規範之情形而未於期限內改 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">善</span><span style="font-size: 14pt; font-family: 標楷體;">，或經發現有重大危害或違規情節重大者，中央衛生主管機關 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">得廢止該證明書。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第五條　　證明書核發後</span><span style="font-size: 14pt; font-family: 標楷體;">，如其登記事項有變更者，持有證明書之藥商 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">應繳納費用並填具申請書表及相關資料，向中央衛生主管機關申 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">請變更</span><span style="font-size: 14pt; font-family: 標楷體;">。未依規定申請變更或未獲核准變更者</span><span style="font-size: 14pt; font-family: 標楷體;">，</span><span style="font-size: 14pt; font-family: 標楷體;">中央衛生主管機 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">關得廢止該證明書。<b> </b></span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第六條　　本辦法之各項申請書表，由中央衛生主管機關定之。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">　　　　　申請人填寫申請書表及檢附之資料，限用繁體中文及英文； </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">如非繁體中文或英文者，應另附繁體中文或英文譯本。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第七條　　</span><span style="font-size: 14pt; font-family: 標楷體;">本辦法自發布日施行。</span> </p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6079&type=0
1420478 查驗登記類,原料藥主檔案(DMF)核備及國產原料藥查驗登記精實送審文件資料 法規命令 DMF核備及原料藥精實送審 詳如附件 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4492&type=0
1420479 臨床試驗類,人類胚胎及胚胎幹細胞研究倫理政策指引 行政解釋 人類胚胎及胚胎幹細胞研究倫理政策指引 詳如附件<br /> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4493&type=0
1420480 其他類,人體研究法 法律 人體研究法 詳如附件 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4494&type=0
1420481 其他類,人體研究倫理審查委員會組織及運作管理辦法 法規命令 人體研究倫理審查委員會組織及運作管理辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依人體研究法（以下簡稱本法）第七條第三項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第三條第二項所定研究機構，得設一個以上倫理審查委員會（以下簡稱審查會）。</span> </p><p><span style="font-family: 新細明體,serif;">前項研究機構，包括學校、醫院、公務機關（構）、法人、團體。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">研究機構應訂定審查會委員遴聘條件、程序、任期、任務、開會程序、議決方式、運作及其他相關事項等規定。</span> </p><p><span style="font-family: 新細明體,serif;">審查會委員之姓名、職業及與研究機構之關係，應予公開。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會審查研究計畫，應先綜合評估研究目的、研究性質、蒐集資料、資訊或檢體之適當性及侵害程度等事項，判斷其為本法第五條第一項所定得免審查、本法第八條所定簡易程序審查或一般程序審查案件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會應訂定並公開審查研究計畫時之各項標準作業程序，包括接觸或擷取使用各種文件、檔案與資料庫之權限及程序，並定期查核、檢討。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會召開一般程序審查會議時，其出席委員應包括機構外之非具生物醫學科學背景委員一人以上。</span> </p><p><span style="font-family: 新細明體,serif;">五人以上，不足七人之審查會，應有三分之二以上之委員出席；七人以上之審查會，應有半數以上之委員出席，始得開會。</span> </p><p><span style="font-family: 新細明體,serif;">出席委員均為單一性別時，不得進行會議。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會應符合下列事項：</span> </p><p><span style="font-family: 新細明體,serif;">一、審查委員及行政事務人員，應簽署保密協定。</span> </p><p><span style="font-family: 新細明體,serif;">二、審查委員及行政事務人員，應定期接受教育訓練課程。</span> </p><p><span style="font-family: 新細明體,serif;">三、具有適當之行政事務人員，並定明其工作職掌。</span> </p><p><span style="font-family: 新細明體,serif;">四、具備處理行政事務之處所及適當之檔案儲存空間。</span> </p><p><span style="font-family: 新細明體,serif;">前項第二款教育訓練課程證明文件，應經審查會審查，並妥善保存。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查委員遇有下列情形之一者，應即迴避，不得參加審查：</span> </p><p><span style="font-family: 新細明體,serif;">一、為受審研究計畫或其子計畫之主持人、協同主持人或委託人。</span> </p><p><span style="font-family: 新細明體,serif;">二、與受審研究計畫主持人有配偶、四親等內之血親或三親等內之姻親或曾有此關係。</span> </p><p><span style="font-family: 新細明體,serif;">三、與受審研究計畫委託廠商具有聘僱關係。</span> </p><p><span style="font-family: 新細明體,serif;">四、有具體事實，足認有偏頗之虞。</span> </p><p><span style="font-family: 新細明體,serif;">五、其他經審查會決議應予迴避者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">研究計畫之審查，應至少包括下列事項：</span> </p><p><span style="font-family: 新細明體,serif;">一、主持人資格。</span> </p><p><span style="font-family: 新細明體,serif;">二、研究對象之條件及召募方式。</span> </p><p><span style="font-family: 新細明體,serif;">三、計畫之內容及其執行方式與場所。</span> </p><p><span style="font-family: 新細明體,serif;">四、本法第十四條所定告知同意事項、告知對象、同意方式及程序。</span> </p><p><span style="font-family: 新細明體,serif;">五、研究對象之保護，包括諮詢及投訴管道等。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">前條審查會會議之議決方式，以多數決為原則；以投票方式表決時，應記錄其正、反等表決情形。未出席會議之委員，不得參與表決。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第八條所定簡易程序審查，應由委員一人以上為之。</span> </p><p><span style="font-family: 新細明體,serif;">前項簡易程序審查案件，委員得代表審查會行使核准之決定，並將結果提審查會報告。</span> </p><p><span style="font-family: 新細明體,serif;">前項審查案件，委員未為核准之決定時，應經一般程序審查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會之會議紀錄，應予公開。</span> </p><p><span style="font-family: 新細明體,serif;">前項公開之內容，應至少包括會議日期、出席與缺席委員姓名、研究計畫名稱、討論內容摘要及決議事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會應依本法第十七條第一項規定，每年至少一次定期查核研究計畫之執行情形；研究計畫有下列情形之一者，審查會應即查核：</span> </p><p><span style="font-family: 新細明體,serif;">一、足以影響研究對象權益、安全或褔祉之情事。</span> </p><p><span style="font-family: 新細明體,serif;">二、研究對象發生嚴重不良事件或反應。</span> </p><p><span style="font-family: 新細明體,serif;">三、出現影響計畫風險利益評估之重要事件或資訊。</span> </p><p><span style="font-family: 新細明體,serif;">前項查核，得以書面或實地查證方式為之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會依前條規定查核結果，應以書面通知計畫主持人；其有變更原審查決定者，並應載明。</span> </p><p><span style="font-family: 新細明體,serif;">審查會查核結果有本法第十七條第二項、第三項所定應通報情形者，應於作成決定後十四日內，通報研究機構及中央目的事業主管機關。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會應要求計畫主持人於計畫完成後，提報執行情形及結果。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">審查會應保存計畫審查、查核、期中及期末報告等相關資料至計畫結束後三年，並供中央目的事業主管機關隨時調閱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6049&type=0
1420482 臨床試驗類,人體細胞組織優良操作規範 法規命令 人體細胞組織優良操作規範 <p style="margin-bottom: 12pt; text-align: center;"><span><strong>91.12.13<span style="font-family: 新細明體;">衛署醫字第</span>0910078677<span style="font-family: 新細明體;">號公告</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">壹、</span> <span style="font-family: 新細明體;">總則</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">一、</span> <span style="font-family: 新細明體;">為預防因使用人體細胞組織物而導入、傳播及擴散傳染病，特訂定本規範。<br /><br />本規範協助機構確保其人體細胞組織物未含有傳染病病原，在製造過程中未受污染，且不致因製造不當而影響人體細胞組織物效用與完整性</span> <span style="font-family: 新細明體;">。<br /><br />人體細胞組織優良操作規範（以下簡稱本規範）適用於人體細胞組織物，其製造所使用之方法、設施及管制措施，包括人體細胞組織提供者之篩檢與檢驗、人體細胞組織物之採集、處理、貯存、標示、包裝及配送等過程。<br /><br />有關人體細胞組織提供者合適性（</span>donor suitability<span style="font-family: 新細明體;">）之規範，另定之。</span>&nbsp;</strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二、</span> <span style="font-family: 新細明體;">人體細胞組織物屬於藥事法令規定之生物藥品或醫療器材者，依其規定，並以規範做為補充規定。<br /><br />人體細胞組織物屬於人體器官移植條例</span> <span style="font-family: 新細明體;">、醫療法</span> <span style="font-family: 新細明體;">或其他法令所規範者，依其規定，並以本規範做為補充規定。<br /><br />人體細胞組織物非屬於現行法令所規範者，或應適用之法令不明確，於釐清法令適用疑義之前，適用本規範。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三、</span> <span style="font-family: 新細明體;">本規範專用名詞定義如下：<br /><br />（一）</span> <span style="font-family: 新細明體;">人體細胞組織物：指用於植入</span>(implanted)<span style="font-family: 新細明體;">、移植</span>(transplanted)<span style="font-family: 新細明體;">、輸注</span>(infused)<span style="font-family: 新細明體;">或轉植</span>(transferred)<span style="font-family: 新細明體;">於人體之人體細胞、組織、或以人體細胞或組織所構成之產品（</span>human cell, tissue, or cellular or tissue-based product<span style="font-family: 新細明體;">）。如骨骼、韌帶、皮膚、心瓣膜、眼角膜、取自臍帶血或周邊血液之造血幹細胞、自體移植使用之軟骨、合成基質上之上皮細胞、精液或其他生殖組織等項目</span> <span style="font-family: 新細明體;">。但下列項目，不在此限：<br /><br /></span>1. <span style="font-family: 新細明體;">使用於移植，帶有血管之人體器官。<br /><br /></span>2. <span style="font-family: 新細明體;">全血、血液成分血或血液衍生產品（</span>blood derivative product<span style="font-family: 新細明體;">）。<br /><br /></span>3. <span style="font-family: 新細明體;">人體分泌物或抽取物，如乳汁、膠原及細胞因子（</span>cell factors<span style="font-family: 新細明體;">）等，但精液屬於本規範所稱人體細胞組織物。<br /><br /></span>4. <span style="font-family: 新細明體;">人體細胞組織物製造過程之輔助物。<br /><br /></span>5. <span style="font-family: 新細明體;">人類以外動物之細胞、組織或器官。<br /><br /></span>6. <span style="font-family: 新細明體;">體外使用之診斷用產品。<br /><br />（二）</span> <span style="font-family: 新細明體;">機構（</span>establishment<span style="font-family: 新細明體;">）：指於一個管理階層之控制下，位於一處所，而從事人體細胞組織物製造之事業，如下列機構：<br /><br /></span>1<span style="font-family: 新細明體;">、從事製造人體細胞組織物之個人、合夥、公司、法人及其他團體。<br /><br /></span>2<span style="font-family: 新細明體;">、接受製造者委託，提供人員或設施從事人體細胞組織物製造之單位或部門。<br /><br />（三）</span> <span style="font-family: 新細明體;">製造（</span>manufacture<span style="font-family: 新細明體;">）：指人體細胞組織物之採集、製程、貯存、標示、包裝、配送、對提供者之篩檢與檢驗等過程之一部或全部。<br /><br />（四）</span> <span style="font-family: 新細明體;">捐贈者（</span>donor<span style="font-family: 新細明體;">）：指提供細胞或組織，供製造人體細胞組織物之人或屍體。<br /><br />（五）</span> <span style="font-family: 新細明體;">接受者（</span>recipient<span style="font-family: 新細明體;">）：指接受人體細胞組織物植入、移植、輸注或轉植之人。<br /><br />（六）</span> <span style="font-family: 新細明體;">受貨人（</span>consignee<span style="font-family: 新細明體;">）：指於配送過程中，收受人體細胞組織物之人。<br /><br />（七）</span> <span style="font-family: 新細明體;">採集（</span>recovery<span style="font-family: 新細明體;">）：指從捐贈者獲得細胞或組織之過程。<br /><br />（八）</span> <span style="font-family: 新細明體;">處理（</span>processing<span style="font-family: 新細明體;">）：指任何作用於產品上之行為，包括製備（</span>preparation<span style="font-family: 新細明體;">）、滅菌（</span>sterilization<span style="font-family: 新細明體;">）、外來病原之去活性化及移除（</span>steps to inactivate and remove adventitious agents<span style="font-family: 新細明體;">）、防腐以備貯存（</span>preservation for storage<span style="font-family: 新細明體;">）、自貯存中取出（</span>removal from storage<span style="font-family: 新細明體;">）等，但不包括採集、貯存、標示、包裝、配送、對捐贈者之篩檢與檢驗等行為。<br /><br />（九）</span> <span style="font-family: 新細明體;">貯存（</span>storage<span style="font-family: 新細明體;">）：指保存產品以供未來之製程或配送。<br /><br />（十）</span> <span style="font-family: 新細明體;">配送（</span>distribution<span style="font-family: 新細明體;">）：指產品之運送（包括進口及出口），但不以持有該產品者為限。<br /><br />（十一）</span> <span style="font-family: 新細明體;">產品偏差（</span>product deviation<span style="font-family: 新細明體;">）：指產品表現出偏離本規範、現行標準或規格，發生不良事件等情形。發生不良事件，指該事件可能使產品傳播傳染病原或傳染病至接受者、使產品污染或使產品之效用或完整性受到負面影響者。<br /><br />（十二）</span> <span style="font-family: 新細明體;">客戶怨訴（</span>complaint<span style="font-family: 新細明體;">）：指客戶以書面、口頭或電子通訊方式提出之下列申訴：<br /><br /></span>1. <span style="font-family: 新細明體;">產品傳播或可能傳播傳染病予接受者。<br /><br /></span>2. <span style="font-family: 新細明體;">產品之效用或完整性受損。<br /><br /></span>3. <span style="font-family: 新細明體;">其他任何可能違反本規範之產品相關問題。<br /><br /><br /><br />四、</span> <span style="font-family: 新細明體;">本規範條款之適用原則<br /><br />（一）</span> <span style="font-family: 新細明體;">機構僅從事部分製造行為者，得僅遵守該部分製造行為之相關規定。但機構如以契約、協議或其他方式，利用他機構從事製造者，仍應確保該製造行為符合本規範之規定。<br /><br />（二）</span> <span style="font-family: 新細明體;">核定產品符合放行標準並將其備妥供配送之機構，不論其是否自為配送，應確保該產品符合本規範及相關法令之規定。<br /><br />（三）</span> <span style="font-family: 新細明體;">本規範條款稱「視情況」（</span>where appropriate<span style="font-family: 新細明體;">）時，推定其為強制規定，但機構得證明有其他適當之代替方法。惟本規範條款之規定於下列情形視為強制規定，即機構若違反該規定時，可合理預期其產品將無法符合有關防止傳染病及其病原之導入、傳播及擴散之規定，或預期該機構將不能執行必要補救措施（</span>corrective actions<span style="font-family: 新細明體;">）。<br /><br /><br /><br /><br /></span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">貳、品質計畫之建立與維持</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五、機構應依其所製造人體細胞組織物之性質及製造過程，建立並維持符合本規範規定之品質計畫（</span>quality program<span style="font-family: 新細明體;">）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六、品質計畫係為確保下列事項之實施：<br /><br />（一）建立並維持適當的作業程序，且遵守本規範第肆章有關程序之規定。<br /><br />（二）設置下列作業程序：<br /><br /></span>1. <span style="font-family: 新細明體;">接收、調查、評估及紀錄相關資訊。<br /><br /></span>2. <span style="font-family: 新細明體;">將任何有關產品效用與完整性、產品可能受污染或有傳染疾病潛在危險之資訊，通知收件者或曾自同一提供者採集細胞或組織之機構。<br /><br /></span>3. <span style="font-family: 新細明體;">對於產品配送後才獲得之資訊，評估其對產品之影響並通知該產品之配送對象，必要時實施檢疫、回收產品或通報中央衛生主管機關。<br /><br />（三）採取必要補救措施（</span>corrective actions<span style="font-family: 新細明體;">）（包括產品缺失（</span>deficiency<span style="font-family: 新細明體;">）之再稽核（</span>reaudits<span style="font-family: 新細明體;">））並製作紀錄。補救措施應為有效，且不會對產品有不良影響。補救措施應視情況包含處理該問題之立即措施及預防缺失再發生之長期措施。<br /><br />前項紀錄，應視情況記載下列事項：<br /><br /></span>1. <span style="font-family: 新細明體;">受影響產品之辨識及處置。<br /><br /></span>2. <span style="font-family: 新細明體;">問題之性質。<br /><br /></span>3. <span style="font-family: 新細明體;">採取之補救措施。<br /><br /></span>4. <span style="font-family: 新細明體;">採取補救措施之日期。<br /><br />（四）人員受到適當之教育訓練。<br /><br />（五）依本規範規定建立並維持必要的品質監控機制。<br /><br />（六）依本規範規定建立並維持紀錄保存機制。<br /><br />（七）依本規範或其他法令之規定，調查、紀錄及通報產品偏差。上開調查，應包括產品偏差的審查、評估、原因之判斷、採取之補救措施。機構應每年至少一次定期回顧及分析所有產品偏差，以辨明產品偏差之趨勢，並採取適當預防措施。機構應中央衛生主管機關之通知，提出分析報告。<br /><br />（八）實施評估、調查、稽核及其他必要措施，以確保遵守本規範之規定。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">七、品質計畫之專責人員<br /><br />機構應指派專責人員，並授權其負責確保品質計畫之有效建立與維持。該人員應向機構管理者報告品質計畫之執行情形，每年至少一次。若該人員於機構中兼任其他工作，則對該工作不得自為最後之監督。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">八、稽核<br /><br />（一）本規範所規定之品質稽核，應每年至少執行一次。必要時，並應執行特別稽核。稽核應依一定程序為之，以確保品質計畫之有效執行，辨認產品偏差之趨向及重複發生之問題。<br /><br />（二）品質稽核人員須具備相關知識、訓練與經驗。被稽核事項之直接負責人員，不得自為稽核人員。<br /><br />（三）稽核或再稽核之報告應妥為保存，交由機構管理者審閱，並製作審閱紀錄。</span>&nbsp;<br /><br /><br /><br /><span style="font-family: 新細明體;">九、使用電腦或自動化資料處理設備，從事有關品質計畫、製造或追蹤產品、資料紀錄等工作者，機構應依計畫（</span>protocol<span style="font-family: 新細明體;">）對電腦軟體之預期功能執行確效（</span>validate<span style="font-family: 新細明體;">）檢查。如有變更軟體，在批准與發布之前也應執行確效檢查。執行確效檢查與其結果，應製作紀錄。<br /><br /><br /><br />十、應建立並維持執行品質計畫（含品質稽核）之作業程序。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">參、組織與人員</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十一、機構應設置適當之組織架構及充足之工作人員。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十二、工作人員應具備相關教育與經驗，並僅執行其可勝任之職務。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十三、工作人員應接受訓練或繼續教育，並明瞭執行職務不當所可能造成的後果，如，散布傳染病或其病原之危險、與傳染病或其病原有關之危害、產品效用與完整性受損所造成之危險。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十四、工作人員之教育、經歷、訓練與繼續教育之紀錄，應予保存。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">肆、作業程序</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十五、機構應就製造人體細胞組織物之所有重要步驟，建立並維持相關作業程序。<br /><br />前項程序應注意確保產品不含相關的傳染病病原、產品於製程中未受污染、產品之效用與完整性未因不當製程而受損，以避免因使用產品而增加導入、傳播及散布傳染病之風險。<br /><br />第一項之程序應確保符合本規範之規定。<br /><br />所有程序於實施前，應經負責人員審查並核准。所有程序，並應每年定期審查至少一次，必要時，應予修正。上開審查結果，並應製作紀錄。<br /><br />第一項之程序，原則上應提供相關工作人員於工作地點查閱。<br /><br />任何偏離作業程序之行為應有正當理由，且應經負責人員指示，並製作紀錄。<br /><br />現行之標準作業程序（例如，其他機構所製作之技術手冊等），如符合本規範之規定，機構得予採行。<br /><br />作廢的程序亦應保存十年以上。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">伍、設施或場所</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十六、製造設施或場所應有適當之空間、結構及地點，以便於清潔、維修及操作：並應有良好保養，充足之照明、通風、給水、排水、清洗及衛生設備。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十七、製造設施或場所應劃分成各獨立工作區域或設置管制機制，以避免產品之不當標示、混雜、污染、交叉污染或意外暴露於傳染病原。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十八、清潔與衛生<br /><br />（一）製造設施或場所應保持清潔、衛生及秩序。<br /><br />（二）污水、垃圾或其他廢棄物之清理，應注意時效、安全及衛生。<br /><br />（三）機構應建立清潔衛生工作之作業程序，該程序應分派相關工作，並描述具體工作方法與時間表。<br /><br />（四）主要的清潔及衛生工作，均應製作並保存相關紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">陸、環境管制與監控</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">十九、當環境可能對產品之功能與完整性發生不良影響，或引起產品、設備之污染或交叉污染，或使產品意外曝露於傳染病病原，則應建立並維持有關環境管制、監控及提供適當操作環境之作業程序。該程序應視情況提供下列管制及監控機制：<br /><br />（一）溫度與濕度控制。<br /><br />（二）通風與空氣濾淨。<br /><br />（三）工作房與設備之清潔、消毒，以確保無菌操作。<br /><br />（四）無菌操作環境控制設備之維護保養。<br /><br />（五）環境中生物（</span>organisms<span style="font-family: 新細明體;">）之監控。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十、環境管制機制應定期檢查，評核其妥適性及功能。必要時，應採取適當補救措施。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十一、執行環境管制及監控，應製作並保存相關紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">柒、設備</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十二、供製造使用之設備，應依其預定功能妥為設計、安裝，並置於適當地點以便操作（含清潔與維護），且應不致對產品產生不良影響。供檢查、測量或測試使用之自動化、機械式、電子式、電腦或其他設備，應能產生有效結果。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十三、為避免故障、污染、交叉污染、發生使產品暴露於傳染病病原之意外事件或其他對產品效用與完整性有不良影響之事件，就設備之清潔、消毒及保養工作，應建立並維持其作業程序。設備之清潔、消毒及保養，應依既定時間表實施。<br /><br />二十四、供檢查、測量或測試使用之自動化、機械式、電子式、電腦或其他設備，應依既定作業程序及時間表實施校準。校準作業程序，應包括明確之說明，及有無可供適用之準確度與精密度限值。當校準未達到準確度與精密度之限值時，應採取補救措施重新設定限值，並評估其對產品之不良影響。<br /><br />二十五、應定期檢查設備之潔淨度、衛生與校準，以確保設備保養工作按表落實。<br /><br />二十六、本章規定之保養、清潔、衛生、校準等工作，均應製作並保存相關紀錄。最近期間之紀錄應置於各該設備處供查閱。設備之使用紀錄（包括該設備所製造產品之辨識碼），應予保存。<br /><br /><br /><br />捌、物料與試劑</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十七、機構就受領供製造人體細胞組織物使用之物料與試劑，應建立及維持其進貨作業程序，並查核其是否符合規格，且於查核完成前，不得使用。<br /><br />前項規格係指與避免因產品污染、產品效用與完整性受損所致導入、傳播、散布傳染病之風險增加有關之規格。<br /><br />第一項之查核得由製造機構或供應商實施。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十八、處理或保存人體細胞組織物所使用之試劑，應具有與使用目相當之品質等級；必要時，並應為無菌。機構自製試劑者，其製造程序應經確效檢查且（或）經查核。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二十九、下列紀錄應予保存：<br /><br />（一）進貨紀錄，包括類型、製造商、批號（</span>lot number<span style="font-family: 新細明體;">）、進貨日期及有效期限。<br /><br />（二）查核紀錄（包括查核結果），如由供應商查核，則為供應商出具之查核證明。<br /><br />（三）使用紀錄，包括使用該物料或試劑所製造人體細胞組織物之辨識碼。<br /><br />玖、製程管制</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十、開發、實施、管制及監控製造程序時，應注意確保其人體細胞組織物符合規格，未受污染，具有其效用與完整性，且避免散布傳染病。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十一、當製程中使用之材料，可能對人體細胞組織物之效用或完整性有不良影響時，機構應就該材料之使用與移除工作，建立並維持其作業程序，以確保該材料已被移除或控制在不會對產品效用或完整性有不良影響之濃度內。該材料之移除或控制，並應製作紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十二、採集自不同提供者之細胞組織，不應在製造過程中混雜（</span>pooling<span style="font-family: 新細明體;">）（指物理上之接觸或在同一容器內混合）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十三、機構應視情況建立並維持一定之作業程序，以確保其製程中之中間產品是否符合特定規格。該程序應確保中間產品，於完成檢查、測試或其他查核前，或於取得批准及其記錄前，受到適當管制。中間產品之檢查取樣，應足以代表擬被評估之材料。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾、製程變更</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十四、製程之變更，應建立並維持一定之作業程序。<br /><br />製程之變更應接受查核（</span>verify<span style="font-family: 新細明體;">）或確效（</span>validate<span style="font-family: 新細明體;">）檢查，以確保其不致造成不良影響，並應經具備相關專業知識之負責人員核准後，始得實施。<br /><br />三十五、製程之變更應製作紀錄，包括變更之理由、實施日期、變更之內容、併同修正之相關文件類目、核准者之簽名、核准日期及生效日期。經核准之製程變更應及時通知相關人員。<br /><br /><br /><br />拾壹、製程之確效（</span>validation<span style="font-family: 新細明體;">）檢查</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十六、當某一製程之結果，無法藉由後續的檢查與測試，澈底查核，則該製程應依一定作業程序執行確效檢查，並經核准。執行確效檢查之內容及結果應製作紀錄，由負責核准人員簽名並加註日期。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十七、人體細胞組織物標示或宣傳資料涉及製程時，例如滅菌或病毒去活性化等，該製程應經確效檢查。機構並應保存上開確效證明文件，供主管機關查廠時審閱。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十八、處理硬腦膜（</span>dura matter<span style="font-family: 新細明體;">）應採用經確效檢查之製程。上開製程應於保持產品臨床效用同時，設法降低傳染性海棉狀腦病變（</span>transmissible spongiform encephalopathy<span style="font-family: 新細明體;">）之機率。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三十九、對於經確效之製程，應設置監測及管制之作業程序，以確保其持續遵守相關要求。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十、對於經確效之製程，如有變更原製程或偏離原作業程序之行為時，機構應予審查及評估，視情況執行再確效（</span>revalidation<span style="font-family: 新細明體;">）檢查，並製作紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾貳、標示管制</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十一、人體細胞組織物之標示，應有管制作業程序（如標示正確性、易讀性及完整性之查核），以確保產品之辨識並防止產品混雜。上開程序應確保產品之標示符合本規範及相關法令規定，並確保產品於配送時，附有核定提供者合適性（</span>donor suitability<span style="font-family: 新細明體;">）之文件。<br /><br />拾參、貯存</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十二、機構應管制貯存與倉儲區域，以防止人體細胞組織物或物料之混雜、混淆、變質、污染、交叉污染及任何對產品效用與完整性之不良影響，並防止不當之放行（</span>release for distribution<span style="font-family: 新細明體;">）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十三、溫度<br /><br />（一）</span> <span style="font-family: 新細明體;">人體細胞組織物應貯存於適當之溫度，且不得逾越貯存期限。<br /><br />（二）</span> <span style="font-family: 新細明體;">各項製程中之貯存溫度範圍，應予確立，以確保產品效用與完整性，防止產品變質，並抑制傳染病病原之生長。<br /><br />（三）</span> <span style="font-family: 新細明體;">貯存之溫度應妥為維持，並製作紀錄。上開紀錄應定期檢查，以確保溫度未逾越範圍。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十四、人體細胞組織物應視情況依下列因素訂定其有效期間：<br /><br />（一）</span> <span style="font-family: 新細明體;">產品種類。<br /><br />（二）</span> <span style="font-family: 新細明體;">製造程序（含保存方法）。<br /><br />（三）</span> <span style="font-family: 新細明體;">貯存條件。<br /><br />（四）</span> <span style="font-family: 新細明體;">包裝。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十五、因故無法符合貯存條件時，應採取矯正措施並製作紀錄。<br /><br /><br /><br />拾肆、收受與配送</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十六、機構應就人體細胞組織物之收受</span>/<span style="font-family: 新細明體;">進料（</span>receipt<span style="font-family: 新細明體;">）、驗收或退回</span>(acceptance or rejection)<span style="font-family: 新細明體;">、配送、及銷毀或廢棄（</span>destruction or other disposition<span style="font-family: 新細明體;">），建立並維持作業程序，且製作紀錄。<br /><br />前項紀錄應記載下列事項：<br /><br />（一）人體細胞組織物之辨識碼。<br /><br />（二）作業內容與結果。<br /><br />（三）作業日期。<br /><br />（四）人體細胞組織物數量。<br /><br />（五）人體細胞組織物之廢棄處置，如受貨人資料（</span>identity of consignee<span style="font-family: 新細明體;">）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十七、為處理、配送或其他製造作業，而收受（進料）、驗收或退回人體細胞組織物，應建立並維持一定之作業程序。收受人體細胞組織物（進料）後，應立刻查核其當時狀況（如有關檢疫、捐贈者篩檢與檢驗、產品處理之狀況），並依產品狀況妥為處置。收受人體細胞組織物（進料）後，應依一定程序檢查產品有無損害、污染、變質、或完整性受損之現象。驗收或退回應製作紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十八、人體細胞組織物之配送，應建立並維持一定作業程序（如產品放行標準），對於檢疫中、受到污染、已變質、違反本規範所製造、來自不合適之捐贈者、或未完成捐贈者合適性評定之產品，應不予放行。人體細胞組織物配送前，機構應查核並記錄其是否符合放行標準，且審閱該人體細胞組織物所有相關記錄。配送之核准應由負責人員製作記錄並加註日期。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">四十九、產品包裝與運送容器之設計、確效檢查、製作，應確保產品效用與完整性，並防止產品在通常之處理、貯存、作業或配送過程中，發生損害、變質、污染或其他不良影響。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十、應訂定運送各類人體細胞組織物應遵守之運送條件。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十一、應建立並維持的程序，當產品被退回機構，據以決定該產品是否合適歸入盤存。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾伍、紀錄</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十二、依本規範要求，執行重要步驟，應同步維持施行成效之紀錄。此規範中述及之行動，須有文件化之證明紀錄據以顯示守法性。所有紀錄應屬準確、不得銷毀與易讀。凡涉及特定人體細胞組織物相關聯之人（部門、執事者）、事（執行經歷）、地、物、時（日期、時間）詳細紀錄足供鑑別。紀錄之保全系統，應足以保證人體細胞組織物的提供者與接受者資料的機密性。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十三、應建立及維持紀錄管理系統。在此系統之下，有關製造特定人體細胞組織物的紀錄，應予保存於歷史檔案，有助於產品經銷前、或必要時對產品釋出後之審查，以作為追蹤評估或調查資料之一部分。附屬於生產每種型式人體細胞組織物的紀錄（例如：程序、規格、標示及包裝程序、設備日誌）應在紀錄管理系統下運作與維護之。倘紀錄分散多處保管，則紀錄管理系統應經設計以保證能迅速辨認、儲位及檢索所有紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十四、應建立並維持程序，以保證遵守本規範規定保管紀錄要求，並應保存有關傳染病測試結果與詮釋文件，其中包括測試實驗室的名稱與地址。應建立篩檢提供者相關傳染病之結果與詮釋文件並維持之。應維持核決提供者適切性文件，包括權責者姓名及核決日期。有關提供者身分及相關醫療紀錄等資訊，應使用中文；倘文件使用其他語言，則應翻譯成中文，並附上該特定翻譯文件之翻譯者有關正確無訛的實筆聲明。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十五、紀錄得以電子形式、原始書面紀錄或照片寫真、顯微底片版、或微膠片保存，在此情況下，合適的閱讀機或複製設備應能便易地獲得。儲存於自動資料處理系統之紀錄應有備份。電子文件與電子簽章，應遵照電子簽章法及其他相關規定辦理。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十六、紀錄應保存十年，然而，凡有關人體細胞組織物的紀錄，於產品植入手術、產品移植手術、或注入與機轉成產品之日期以後，應還增長保存時間至少十年；倘產品植入手術、產品移植手術、或注入與機轉成產品之日期並不確定時，於產品配送、廢棄或過期之日期以後，至少再保存十年。腦膜樣本經適當拋棄處置後，該腦膜樣本檔案應該要保存十年。機構應預備萬一歇業之後，所有紀錄仍能依照規定要求之期限保存之。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十七、契約、委託由其他機構製造加工之協議、或是合議均應建立並維持。該等紀錄應包含對方機構名稱、地址及合約、以及協議關係人之權責或其他合議。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾陸、追蹤</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十八、機構製造人體細胞組織物，應根據本規範追蹤製程中任何步驟之每個產品。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五十九、產品追蹤方法<br /><br />（一）機構應建立並維持產品追蹤方法，據以追蹤人體細胞組織物：<br /><br /></span>1<span style="font-family: 新細明體;">、從提供者到接受者、以至最終處置。<br /><br /></span>2<span style="font-family: 新細明體;">、接受者或提供者的最終處置。<br /><br />（二）機構非完全獨自執行人體細胞組織物製程，部分步驟係責成其他分包商執行，機構僅須符合此節追蹤方法之規定，得由收託分包商就其製程部分，建立及維持轄下產品追蹤方法。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十、機構應保證所生產每個人體細胞組織物，均受分派與標示明確之辨識碼，作為追蹤方法之一部分，例如，採行字母數字順序、關聯產品與提供者以及交付產品之全部紀錄。除非自自體捐贈或指定捐贈之情況下，這類號碼必須特定製作以利追蹤，而且得不包含個人的姓名、健康保險或病歷號碼，機構得採納其他參與製造過程之分包商所分派之編碼、或自行再另新分派代碼。機構應該要建立並維持程序，據以關連新舊代碼。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十一、機構應保證經植入、移植、輸入、轉移至接受者之人體細胞組織物辨識件及型式，都記載於接受者之病歷、或相關聯之紀錄，作為追蹤方法之一部分，使能夠自接受者追蹤至提供者。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十二、機構應登載並維持每件人體細胞組織物的最終處置紀錄，作為追蹤方法之一部分，使能夠自提供者追蹤至接受者或最終處置。必要時，應維護資訊，使能夠立刻鑑別產品之接受者。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十三、機構將人體細胞組織物配送予收件者時或之前，應以書面方式告知收件者此節之規定要求，及該收受機構須遵守規定建立並維持追蹤方法。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十四、硬腦膜捐贈者特別要求<br /><br />每位硬腦膜捐贈者應保管適當之樣本存檔，貯存在適當之條件範圍，於貯存適當之期間，使能夠測試存檔物質是否具有傳染海綿性腦病變之的證據，以及必要時，對受影響之硬腦膜作適當的棄置。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾柒、怨訴檔案</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十五、機構應建立並維持程序，據以立即進行所有怨訴之審查、評估，並予以文件化證明；必要時，包含調查活動。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十六、機構應維持所收到每件怨訴檔案之紀錄，怨訴檔案，應包含足夠之怨訴資訊，以便適合的審查與評估怨訴，包括怨訴提及人體細胞組織物的辨識件，經中央衛生主管機關授權之人員要求下，怨訴檔案應能提供審查及影印。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">六十七、每件怨訴應予審查及評估，以判別該怨訴是否與人體細胞組織物的偏差或不良反應（</span>adverse reaction<span style="font-family: 新細明體;">）有關，依藥物不良通報作業系統或其他適用規則決定是否須作通報。每件怨訴涉及須通報中央衛生主管機關事件者，應及時審查、評估及調查。倘怨訴不須通報中央衛生主管機關事件者，應予審查、評估以決定是否需要調查；調查活動得包含轉送怨訴案副本至其他涉及怨訴有關製程步驟之機構。倘不執行任何研究調查，則機構應維持紀錄，包含為何研究調查未執行之理由及權責者之姓名。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾捌、附則</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong>&nbsp;</strong></span></p><p><span><strong><span style="font-family: 新細明體;">六十八、本規範實施日期另公告之</span></strong></span></p><p><strong><span style="font-size: 13px; font-family: arial;"><span style="font-family: 新細明體,serif;">衛生署公告網址</span>:</span></strong></p><p><span><strong><span style="font-size: 13px; font-family: arial;">http://www.doh.gov.tw/newverprog/proclaim/content.asp?class_no=0&amp;now_fod_list_no=&amp;array_fod_list_no=&amp;level_no=1&amp;doc_no=19364</span></strong></span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6086&type=0
1420483 臨床試驗類,人體試驗管理辦法 法規命令 人體試驗管理辦法 <p style="text-align: center;"><b>&nbsp;</b></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第一條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">本辦法依醫療法（以下稱本法）第七十九條之一規定訂定之。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第二條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">新藥品、新醫療器材於辦理查驗登記前，或醫療機構將新醫療技術，列入常規醫療處置項目前，應施行人體試驗研究（以下稱人體試驗）。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第三條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">醫療機構施行人體試驗，應擬訂計畫，向中央主管機關申請核准。 </span></p><p style="layout-grid-mode: char; 10: ;"><span style="font-size: 14pt; font-family: 標楷體;">前項計畫，應載明下列事項： </span></p><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">一、主題。 </span></pre><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">二、目的。 </span></pre><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">三、方法： </span></pre><pre style="layout-grid-mode: char; margin-left: 89.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">（一）接受人體試驗者（以下稱受試者）之條件、招募方法及數目。 </span></pre><pre style="layout-grid-mode: char; margin-left: 89.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">（二）實施方式。 </span></pre><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">（三）人體試驗期間及預計進度。 </span></pre><pre style="layout-grid-mode: char; margin-left: 96pt;"><span style="font-size: 14pt; font-family: 標楷體;">（四）治療效果之評估及統計方法。 </span></pre><pre style="layout-grid-mode: char; margin-left: 96pt;"><span style="font-size: 14pt; font-family: 標楷體;">（五）受試者之追蹤及必要之復健計畫。 </span></pre><pre style="layout-grid-mode: char; margin-left: 68.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">四、受試者同意書內容。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">五、主持人及協同主持人之學、經歷及其所受訓練之資料。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">六、有關之國內、外已發表之文獻報告。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82pt;"><span style="font-size: 14pt; font-family: 標楷體;">七、其他國家已核准施行者，其證明文件。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82pt;"><span style="font-size: 14pt; font-family: 標楷體;">八、所需藥品或儀器設備，包括必須進口之藥品或儀器名稱、數量。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82pt;"><span style="font-size: 14pt; font-family: 標楷體;">九、預期效果。 </span></pre><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 54pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">十、可能引起之損害及其救濟措施。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第四條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">前條之主持人應具下列資格： </span></p><p style="layout-grid-mode: char; 81pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">一、領有執業執照並從事臨床醫療五年以上之醫師、牙醫師或中醫師。 </span></p><p style="layout-grid-mode: char; 81pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">二、最近六年曾受人體試驗相關訓練三十小時以上；於體細胞或基因治療人體試驗之主持人，另加五小時以上之有關訓練。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">三、最近六年研習醫學倫理相關課程九小時以上。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">曾受</span><span style="font-size: 14pt; font-family: 標楷體;">醫師懲戒處分，或因違反人體試驗相關規定，受停業一個月以上或廢止執業執照處分者，不得擔任主持人。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第五條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">依本法第七十九條第一項但書召募之成年或已結婚未成年之受試者，主持人應依下列順序取得其關係人之同意： </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">一、 </span><span style="font-size: 14pt; font-family: 標楷體;">配偶。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">二、 </span><span style="font-size: 14pt; font-family: 標楷體;">父母。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">三、 </span><span style="font-size: 14pt; font-family: 標楷體;">同居之成年子女。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">四、 </span><span style="font-size: 14pt; font-family: 標楷體;">與受試者同居之祖父母。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">五、 </span><span style="font-size: 14pt; font-family: 標楷體;">與受試者同居之兄弟姊妹。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">六、 </span><span style="font-size: 14pt; font-family: 標楷體;">最近一年有同居事實之其他親屬。 </span></p><p style="layout-grid-mode: char; 62: ;"><span style="font-size: 14pt; font-family: 標楷體;">前項關係人之同意，不得違反受試者曾表示之意思。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第六條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">依本法第七十八條第三項規定會同審查人體試驗計畫（以下稱審查會）之人員名單及會議紀錄，應予公開。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 54pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">前項審查，應訂定作業規範並公開之。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第七條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">人體試驗計畫</span><span style="font-size: 14pt; font-family: 標楷體;">之審查，應注意下列事項：</span> </p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">一、人體試驗設計應符合最低風險原則，並考量合理之風險、利益。 </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">二、執行方式及內容符合科學原則。</span> </p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">三、</span><span style="font-size: 14pt; font-family: 標楷體;">受試者之條件及召募方式。 </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">四、受試者之醫療照護及損害補償或其他救濟機制。 </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">五、受試者之隱私保護。 </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">六、受試者同意書內容及告知程序。 </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">七、易受傷害族群之保護。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">八、保障受試者安全之必要管理措施。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第八條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">審查人員有下列情形之一者，應即迴避：</span> </p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">一、為人體試驗計畫之主持人、協同主持人或委託人。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">二、與主持人有配偶、四親等內之血親或三親等內之姻親或曾有此關係。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">三、與人體試驗計畫委託人有聘僱關係。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">四、其他經</span><span style="font-size: 14pt; font-family: 標楷體;">審查會</span><span style="font-size: 14pt; font-family: 標楷體;">認有利益迴避之必要者。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第九條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">審查會對其審查通過之人體試驗應</span><span style="font-size: 14pt; font-family: 標楷體;">每年至少查核一次</span><span style="font-size: 14pt; font-family: 標楷體;">。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 44: ;"><span style="font-size: 14pt; font-family: 標楷體;">前項查核發現有</span><span style="font-size: 14pt; font-family: 標楷體;">下列情事之一者，得令其限期改善或終止人體試驗： </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">ㄧ、未依規定經審查會通過或中央主管機關核可，自行變更人體試驗內容。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">二、顯有影響受試者權益、安全之事實。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">三、不良事件發生數或嚴重度顯有異常。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">四、有足以影響人體試驗成果評估之事件。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">五、人體試驗未完成前，有具體事實證明</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">並無實益、</span><span style="font-size: 14pt; font-family: 標楷體;">風險高於潛在利益</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">，或顯有實益致不利於對照組。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 44: ;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">中央主管機關知有前項情事，得令其終止</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十條<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">審查會應將</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗計畫</span><span style="font-size: 14pt; font-family: 標楷體;">、會議紀錄、查核紀錄等相關文件，保存至人體試驗完成後至少三年。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十一條<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">醫療</span><span style="font-size: 14pt; font-family: 標楷體;">機構不得向受試者收取</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗有關之任何費用。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十二條<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">受試者於</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗施行期間發生下列情事，或任何時間發生與</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗有關之下列情事時，醫療機構應通報中央主管機關：</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">一、<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">死亡。</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">二、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">危及生命。</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">三、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">永久性身心障礙。</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">四、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">受試者之胎兒或新生兒先天性畸形。</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">五、<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">需住院或延長住院之併發症。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 90pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">六、 </span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">其他可能導致永久性傷害之併發症。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 45pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">前項通報應<span style="color: #000000;">於得知事實後七日內為之，</span></span><span style="font-size: 14pt; font-family: 標楷體;">並於十五日內檢具詳細調查資料送中央主管機關。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 45pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十三條<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">中央主管機關得令施行</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗之醫療機構提供</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗計畫摘要、收案數、性別比、年齡統計、受試者同意書審查結果及可能風險等有關資料，或對醫療機構進行必要之查核，醫療機構不得妨礙、規避或拒絕。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 45pt: ;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">前項查核，中央主管機關得委託相關團體為之。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十四條<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">受試者之生物檢體、個人資料或其衍生物，於</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗結束後，應即銷毀。受試者同意提供再利用者，應</span><span style="font-size: 14pt; font-family: 標楷體;">經審查會審查通過，未去連結者應</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">再次取得受試者書面同意。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十五條<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">醫療機構於</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗期間，不得對外發表成果或為宣傳。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第十六條<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 14pt; font-family: 標楷體;">本辦法自發布日施行。 </span></p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6050&type=0
1420484 其他類,人體器官組織細胞輸入輸出管理辦法 法規命令 人體器官組織細胞輸入輸出管理辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依人體器官移植條例第十四條之一第二項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">感染性器官、組織、細胞之輸入或輸出，應依傳染病防治法及其相關規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官、組織、細胞，以法人、醫療機構、教學研究機構及其他經中央衛生主管機關核准者為限。</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入或輸出之器官、組織、細胞，其用途以人體移植、教學、研究、保存及其他經中央衛生主管機關核准者為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官、組織、細胞供人體移植者，其來源應以無償捐贈方式為之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">死刑犯捐贈之器官、組織、細胞，不得申請輸入或輸出。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本國之人類胚胎幹細胞或胚胎幹細胞株，不得申請輸出。但經中央衛生主管機關核准者，不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官、組織、細胞者，應填具申請書，載明下列事項，向中央衛生主管機關提出申請：</span> </p><p><span style="font-family: 新細明體,serif;">一、輸入或輸出國別。</span> </p><p><span style="font-family: 新細明體,serif;">二、輸入或輸出器官、組織、細胞類別及其用途。</span> </p><p><span style="font-family: 新細明體,serif;">三、輸入或輸出之期間。</span> </p><p><span style="font-family: 新細明體,serif;">四、輸入或輸出之數量、容量、批次。</span> </p><p><span style="font-family: 新細明體,serif;">五、輸入或輸出之運送方式。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入器官、組織、細胞者，應檢附下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一、輸出國主管機關出具同意輸出之文件或足以證明輸出國未管制輸出之文件。</span> </p><p><span style="font-family: 新細明體,serif;">二、輸入器官、組織、細胞之檢驗證明文件。</span> </p><p><span style="font-family: 新細明體,serif;">三、其他依規定應檢附之文件。</span> </p><p><span style="font-family: 新細明體,serif;">前項第二款之檢驗證明文件，應包括之檢驗項目如附表；其申請分批輸入者，檢驗證明文件得於輸入前七日內補正。</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入人體移植用途之器官、組織、細胞者，除前項文件外，應另檢附下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一、來源單位合法設立之證明文件。</span> </p><p><span style="font-family: 新細明體,serif;">二、來源單位證明捐贈者同意捐贈之文件。</span> </p><p><span style="font-family: 新細明體,serif;">三、捐贈者年齡、器官組織或細胞摘取時間等資料。</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入眼角膜者，前項第三款之文件得於輸入後三十日內補正。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官、組織、細胞，其核准效期至多以三年為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官、組織、細胞者，因業務而知悉或持有他人秘密，</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">不得無故洩漏。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">有下列情形之一者，中央衛生主管機關得撤銷或廢止原核發之輸入或輸出核准文件：</span> </p><p><span style="font-family: 新細明體,serif;">一、以虛偽不實文件申請取得核准文件。</span> </p><p><span style="font-family: 新細明體,serif;">二、輸入或輸出之器官、組織、細胞與核准文件登載內容不符。</span> </p><p><span style="font-family: 新細明體,serif;">三、違反前條規定，洩漏他人秘密。</span> </p><p><span style="font-family: 新細明體,serif;">四、將原申請非移植用途之器官、組織或細胞，轉為人體移植用。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">人體移植用器官、組織、細胞之輸入，申請單位應就實際輸入數量，使用或分配情形，製作紀錄妥為保存至少十年，供中央衛生主管機關查核。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官、組織、細胞，其申請者有下列情形之一者，三年內不得輸入或輸出：</span> </p><p><span style="font-family: 新細明體,serif;">一、未經核准，擅自輸入或輸出器官、組織、細胞。</span> </p><p><span style="font-family: 新細明體,serif;">二、曾經中央衛生主管機關撤銷或廢止輸入或輸出核准文件二次以上。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法發布施行前，已取得中央衛生主管機關核發之輸入或輸出核准文件者，其核准文件有效期限屆滿前，原輸入、輸出核准事項仍屬有效。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p> 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6087&type=0
1420485 臨床試驗類,藥動學試驗基準,小兒族群的藥動學試驗基準 行政解釋 小兒族群的藥動學試驗基準 詳如附件 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4495&type=0
1420486 臨床試驗類,藥品臨床試驗基準,內分泌及新陳代謝治療藥品臨床試驗基準 行政解釋 內分泌及新陳代謝治療藥品臨床試驗基準 詳如附件 2013-12-03 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4496&type=0
1420487 化學製造管制類,指導手冊,分析確效作業指導手冊 行政解釋 分析確效作業指導手冊 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4497&type=0
1420488 臨床試驗類,藥品臨床試驗基準,心血管治療藥品臨床試驗基準 行政解釋 心血管治療藥品臨床試驗基準 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4498&type=0
1420489 查驗登記類,生物相似性藥品查驗登記技術性資料審查重點表 行政解釋 生物相似性藥品查驗登記技術性資料審查重點表 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4499&type=0
1420490 藥政管理類,生物檢體輸出輸入作業要點 行政解釋 生物檢體輸入輸出作業要點 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4501&type=0
1420491 藥政管理類,生物藥品檢驗封緘作業辦法 法規命令 生物藥品檢驗封緘作業辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依藥事法第七十四條第一項規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法適用範圍為微生物學、免疫學學理製造之血清、抗毒素、疫苗、類毒素及菌液等。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">生物藥品輸入或製造後，藥商應填具生物藥品檢驗封緘申請書（格式如附件一），並檢附下列資料，向中央衛生主管機關提出封緘申請，並依通知繳納審查費（含檢驗費、封緘費及旅運費）：</span> </p><p><span style="font-family: 新細明體,serif;">一、輸入包裝清單。</span> </p><p><span style="font-family: 新細明體,serif;">二、藥品許可證或經中央衛生主管機關核可文件之影本。</span> </p><p><span style="font-family: 新細明體,serif;">三、生物藥品原產國國家檢驗機關之檢定合格證明。但原廠經其國家檢驗機關核准自行檢驗者，得以原廠之檢驗紀錄及成績書代之。</span> </p><p><span style="font-family: 新細明體,serif;">四、生物藥品之製程、檢驗方法、規格、標準品及有關文獻。</span> </p><p><span style="font-family: 新細明體,serif;">五、動物原料來源管制之標準操作程序（</span><span style="font-family: calibri;">SOP</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">、及原料來源證明。</span> </p><p><span style="font-family: 新細明體,serif;">六、本批生物藥品製程之分裝數量紀錄與檢定紀錄及成品之檢定紀錄與成績書。</span> </p><p><span style="font-family: 新細明體,serif;">國產製品由其製造廠自行檢驗合格並完成包裝後，提出前項申請，並免附第一款及第三款資料。</span> </p><p><span style="font-family: 新細明體,serif;">屬防疫或外銷用生物藥品，經中央衛生主管機關核准，得於藥品放行前補齊第一項第六款資料。</span> </p><p><span style="font-family: 新細明體,serif;">藥商未依規定繳納審查費、未填具申請書、未備齊資料或有其他不符第一項規定之情形而得補正者，應依中央衛生主管機關補正通知送達之日起二個月內補正。</span> </p><p><span style="font-family: 新細明體,serif;">藥商未能於期限內補正者，應於期限屆至前，以書面敘明理由申請延期；其延期期限，自期限屆至翌日起算一個月，且延期以一次為限。</span> </p><p><span style="font-family: 新細明體,serif;">藥商未於期限屆至前補正或延期一個月後仍逾期未補正者，中央衛生主管機關得依現有資料逕為審查、檢驗與准駁。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關受理檢驗封緘申請後，經派員查核生物藥品運送及貯存之溫度符合貯藏條件者，即抽取適量生物藥品供檢驗或留樣所需；剩餘生物藥品則應予封存，並交由藥商自行保管。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 5&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關得依抽驗生物藥品類別及實際需要執行檢驗項目。</span> </p><p><span style="font-family: 新細明體,serif;">生物藥品經檢驗合格者，由中央衛生主管機關於其包裝上個別加貼藥物檢查證，始得販售、供應。中央衛生主管機關並應核發生物藥品封緘證明書（格式如附件二）或外銷用生物藥品批次放行證明（格式如附件三）予申請封緘檢驗之藥商。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 6&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">配合國家防疫政策或因應緊急重大事件、特殊醫療需要之生物藥品，經中央衛生主管機關核可者，得不適用第五條有關檢驗之規定。</span> </p><p><span style="font-family: 新細明體,serif;">前項生物藥品，經中央衛生主管機關審查其申請資料及查核其運送與貯存之溫度符合貯藏條件後，並於其包裝上個別加貼藥物檢查證，始得販售、供應。中央衛生主管機關並應核發生物藥品封緘證明書或外銷用生物藥品批次放行證明予申請封緘檢驗之藥商。</span> </p><p><span style="font-family: 新細明體,serif;">前項情形，中央衛生主管機關於必要時得抽驗其生物藥品或抽取適量生物藥品備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 7&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">因應緊急醫療需要之生物藥品，藥商得檢附地區醫院以上之主治醫師出具之切結書或醫院申請書，向中央衛生主管機關申請緊急放行所需要之數量。</span> </p><p><span style="font-family: 新細明體,serif;">前項生物藥品，經中央衛生主管機關審查其原廠檢驗成績書後，即得於所申請放行數量之生物藥品包裝上個別加貼緊急放行證，逕予放行；其餘未放行部分應續行辦理檢驗封緘作業。</span> </p><p><span style="font-family: 新細明體,serif;">第一項之切結書或申請書應載明病患急需使用之藥品名稱、使用理由及數量。</span> </p><p><span style="font-family: 新細明體,serif;">藥商應將緊急放行生物藥品之批號、供應對象及數量等資料保存備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 8&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央衛生主管機關得委任所屬食品藥物管理局辦理第三條至第七條所訂生物藥品檢驗封緘相關事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 9&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6051&type=0
1420492 臨床試驗類,生體相等性試驗之受託研究機構管理規範 行政解釋 生體相等性試驗之受託研究機構管理規範 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4502&type=0
1420493 臨床試驗類,多國多中心藥品臨床試驗計畫審查程序 行政解釋 多國多中心藥品臨床試驗計畫審查程序 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4503&type=0
1420494 臨床試驗類,藥品臨床試驗基準,年老病患的藥品臨床試驗基準 行政解釋 年老病患的藥品臨床試驗基準 <div style="layout-grid: 18pt none;" class="WordSection1"><p><b><span style="font-family: 標楷體;">目錄</span></b> </p><p><b><span style="font-family: 標楷體;">第一章、通論</span></b> </p><p><b><span style="font-family: 標楷體;">第二章、臨床試驗之考量</span></b><b> </b></p><p><b><span style="font-family: 標楷體;">第三章、藥動學試驗</span></b><b> </b></p><p><b><span style="font-family: 標楷體;">第四章、藥效</span></b><b><span style="font-family: times new roman,serif;">/</span></b><b><span style="font-family: 標楷體;">劑量</span></b><b><span style="font-family: times new roman,serif;">-</span></b><b><span style="font-family: 標楷體;">反應試驗</span></b><b> </b></p><p><b><span style="font-family: 標楷體;">參考文獻</span></b><b> </b></p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><p><b><span style="font-family: 標楷體;">第一章、通論</span></b> </p><p><span style="font-family: 標楷體;">一、相關準則</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　　　為提昇國內臨床試驗水準，使執行臨床試驗有遵循之原則，本署乃參考本署已公告之「臨床試驗基準」及</span><span style="font-family: times new roman,serif;">ICH</span><span style="font-family: 標楷體;">（</span><span style="font-family: times new roman,serif;">International Conference on Harmonization</span><span style="font-family: 標楷體;">）藥品研發策略有關年老病患用藥的臨床試驗通則，制定本基準。</span> </p><p><span style="font-family: 標楷體;">二、背景</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　因年齡導致產生藥品反應的差異性，可能來自藥動學之改變（藥品之吸收、分佈、代謝、排泄）或是藥效學的改變（對特定血中濃度或其他組織濃度的藥品反應）。老年人的年齡並非唯一會影響其藥動學或藥效學的因素，大部分與年齡相關的差異可能與年齡本身無關，而會發生於所有的年齡層；例如腎臟或心臟功能之衰退、併隨之疾病及併有治療，尤其是併用的藥品。試驗執行者應偵測病患本身會影響藥品療效的主要特質，並了解該特質之影響力，才可能選擇合適劑量以治療年老病患。目前現有與年齡相關的藥效學差異資料相當少，而且執行藥效學試驗以偵測這些差異的能力又不確定，因此只有在這些差異有疑慮時（如臨床試驗結果），或當這些差異相當重要時（如因為狹窄的治療指標），額外的研究以探測年輕與年老病患血中濃度／反應的曲線之差異，才有意義。如果在臨床試驗中包括了年輕與年老的病患，適當的分析每個病人的血中濃度資料，應可以探測與年齡或其他因素相關的重要藥效學差異。</span> </p><p><span style="font-family: 標楷體;">三、老年人的定義</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　老年人是</span><span style="font-family: times new roman,serif;">65</span><span style="font-family: 標楷體;">歲或以上的族群。執行可能用於老年人的藥品之臨床試驗時，儘可能將年紀越老的病患納入試驗，且臨床試驗計畫書中不應設定年老病患的年齡上限。此外，若無特殊需要，臨床試驗也不應排除併有其他疾病之病患，因為唯有納入此類病患，才可能偵測出該藥品與疾病的交互作用。若可能使用此藥品的族群為年齡較大之族群時，則納入年齡較大的老年人的試驗設計更形重要。</span> </p><p><span style="font-family: times new roman,serif;">&nbsp;</span></p><p><b><span style="font-family: 標楷體;">第二章、臨床試驗之考量</span></b><b><span style="font-family: times new roman,serif;"><br /><br /></span></b><b><span style="font-family: 標楷體;">　　</span></b><span style="font-family: 標楷體;">參加臨床試驗的病患應代表該藥品在上市後使用的族群，因此可能用於老年人的藥品，臨床試驗時應納入合理數目的年老病患。通常，老年人應和年輕人納入同一試驗，這樣可以做直接比較。對於不是只發生在老年人的疾病，應納入年老病患至少</span><span style="font-family: times new roman,serif;">100</span><span style="font-family: 標楷體;">名，這樣的人數通常已足以檢測出臨床上重要的差異。一般較不常見的疾病則可納入較少的年老病患。如果該藥品之適應症與年齡相關，則可以考慮只針對年老族群執行臨床試驗，這包括特殊的監測步驟，例如認知功能。另一種方法是將年輕與年老病患納入同一個臨床試驗之下，但依年齡區分，對年長者應特別照護或監測。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　臨床試驗報告內容應包含療效、不良反應、劑量反應和藥品血中濃度－反應的分析，這些分析應考慮基礎人口特性（如年齡、性別、種族）以及病患特性（如腎功能、心臟功能、肝功能、併有疾病及併用藥品，包含酒精和尼古丁）的影響。在個別試驗及整體的有效性、安全性分析中均應執行以上分析。這些分析的結果可能顯示需要更多進行於年老族群或其他族群的劑量－反應</span><span style="font-family: times new roman,serif;">(dose-response) </span><span style="font-family: 標楷體;">或血中濃度－反應試驗。這些額外的試驗是否在上市之前或之後執行，可依其重要性來決定。</span> </p><p><span style="font-family: times new roman,serif;">&nbsp;</span></p><p><b><span style="font-family: 標楷體;">第三章、藥動學試驗</span></b><span style="font-family: times new roman,serif;"> <br /><br /></span><span style="font-family: 標楷體;">　　年齡只是影響老年人藥動學的因素之一，但非最重要的因子。對影響藥動學最重要的因素應直接評估，例如對經腎排泄藥品，腎功能是影響其藥動特性的重要因素。其他可能的影響如年齡，可以依以下第一節中所描述的篩檢方法來評估。如果篩檢不適當或未執行，或者該篩檢顯示年齡是一影響因素，則嚴謹而正式的藥動學試驗應在年老病患執行。</span> </p><p><span style="font-family: 標楷體;">一、藥動學的篩檢</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　儘可能找出改變藥動學的所有因素是很重要的。但是，實際上只能執行有限的特殊交互試驗（藥品交互作用，藥品與疾病交互作用），而且通常只有懷疑有交互作用時，才作研究。使用藥動篩檢法，可從未被懷疑有不尋常藥動特性的病患中，找出具有不尋常藥動特性的次族群病患。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　對於所有或大部分在第二階段臨床試驗或第三階段臨床試驗受試驗者而言，藥動篩檢包含取得一個或數個穩定狀態時的藥品血中濃度，以決定在特定給藥情況下，藥品血中濃度的變異性。關於上述藥動篩檢的方法與分析已經發表於</span><span style="font-family: times new roman,serif;">Sheiner,L.B., and Benet, L.Z.:Clin. Pharm. Ther. 38:481-187(1985)</span><span style="font-family: 標楷體;">。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　只要受試驗者包括不同年齡、性別、種族、體重、胖瘦程度、病史、煙酒量、併用藥品等，即使只有一或兩個穩定狀態下之最低藥品血中濃度測量的粗略篩檢，也能回答一些簡單但重要的問題。使用多線性迴歸分析（或其他方法如混合作用模式）可決定出藥品在不同個體間藥品血中濃度之差異，以及相關的臨床特性，如年齡、性別、種族、體重、去除脂肪後之體重（</span><span style="font-family: times new roman,serif;">lean body mass</span><span style="font-family: 標楷體;">），和穩定狀態下最低藥品血中濃度的關係。亦可找出具有極端數值的受試驗者，這些病患往往需要進一步研究。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　由上述試驗可得知是否老年人與其他年齡層的藥品血中濃度有所差異，亦可得知此種差異是否只單純因年齡不同，或者與年齡相關的其他因素有關。在粗略篩檢之下，只有相當大的差別才會被偵測出來，但以藥品血中濃度之變異而言，也只有相當大的差別才是重要的。當小差別是重要時，較嚴謹的篩檢可以測出微小之差別（</span><span style="font-family: times new roman,serif;">Sheiner and Benet L.Z.:Clin. Pharm. Ther. 38:481-187(1985)</span><span style="font-family: 標楷體;">），例如毒性與治療之藥品血中濃度比例很低的藥品。藥動篩選的一個可能重要發現是，對於具有不同人口學特性（如年齡）或臨床特性（如使用其他藥品）的次族群，即使包含足夠的受試者人數，可能發現藥品血中濃度並無明顯差異。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　藥動篩檢的重要優點是不需要前置假說，即可能測知未預期的結果。若篩檢時有不尋常且重要的發現，或許需要更進一步的試驗。因此，若有次族群（如特定年齡範圍、接受其他藥品者）有顯著較高或較低的藥品血中濃度，尤其是這會增加毒性或減少藥效時，可能必須證實此觀察及探究其原因。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　藥品的治療指標、毒性或藥效與藥品血中濃度之關係，將可決定此查證之重要性及時間點（藥品審核通過之前或在第四階段臨床試驗）。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　篩檢或許也可以幫助解釋第二、三階段臨床試驗的結果，某些不尋常的藥效或不良反應可用病患的藥品血中濃度來解釋。利用臨床數據及篩檢結果應可以觀察出粗略的藥品濃度與反應間</span><span style="font-family: times new roman,serif;">(concentration-response)</span><span style="font-family: 標楷體;">的關係。</span> </p><p><span style="font-family: 標楷體;">二、嚴謹而正式的藥動學試驗</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　嚴謹而正式的藥動學試驗可以在健康的老年人或年老病患進行。選擇一個只納入少數受試者的小規模藥動學試驗，用來檢測在穩定狀態下</span><span style="font-family: times new roman,serif;">(steady state)</span><span style="font-family: 標楷體;">，年老病患與年輕病患</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">或健康的老年人與年輕人受試者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">之間達到一定程度的差異；或是採取一個較大規模、單一劑量的藥動學試驗，使年老病患與年輕病患</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">或健康的老年人與年輕人受試者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">間，在統計上做有意義的比較。不管是採用那一種試驗，如果發現年老病患與年輕病患</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">或健康的老年人與年輕人受試者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">間，具與年齡相關且臨床上重要的差異時，則必須進一步執行一個在穩定狀態下，有足夠受試者之多劑量藥動學試驗，在統計上作有意義的比較。</span> </p><p style="margin-left: 18pt;"><span style="font-family: 標楷體;">三、藥品與疾病和藥品交互作用關係</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　　　若併有疾病與併用藥品對試驗用藥的藥動學有很大的影響，可由藥動篩檢觀察出來。當試驗用藥之治療指標（毒性與治療劑量的比例）低，且該藥之適應症併存其他疾病，併用其他治療的可能性大時，應執行特定的交互作用試驗，這些試驗依個案而定，但應包括：</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　</span> </p><p style="margin-left: 18pt;"><span style="font-family: 標楷體;">（一）</span> <span style="font-family: 標楷體;">交互作用試驗（</span><span style="font-family: times new roman,serif;">Interaction Studies</span><span style="font-family: 標楷體;">）</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　　　</span> </p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">１、</span><span style="font-family: times new roman,serif;">Digoxin</span><span style="font-family: 標楷體;">交互作用</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">許多藥品會改變</span><span style="font-family: times new roman,serif;">digoxin </span><span style="font-family: 標楷體;">的血中濃度，</span><span style="font-family: times new roman,serif;">digoxin</span><span style="font-family: 標楷體;">經常使用在老年人並具潛在毒性，因此對大多數藥品而言，應該評估與</span><span style="font-family: times new roman,serif;">digoxin</span><span style="font-family: 標楷體;">的交互作用。</span><span style="font-family: times new roman,serif;"> </span></p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">２、會影響肝臟代謝的藥品</span> </p><p style="margin-left: 36pt;"><span style="font-family: times new roman,serif;">&nbsp;&nbsp; </span><span style="font-family: 標楷體;">主要經由肝臟代謝的藥品，應評估該藥與肝臟酵素誘導劑（如</span><span style="font-family: times new roman,serif;">phenobarbital</span><span style="font-family: 標楷體;">）或抑制劑（如</span><span style="font-family: times new roman,serif;">cimetidine</span><span style="font-family: 標楷體;">）合併使用之交互作用。特別值得一提的如</span><span style="font-family: times new roman,serif;">cytochrome P-450 debrisoquin hydroxylase</span><span style="font-family: 標楷體;">會被</span><span style="font-family: times new roman,serif;">quinidine </span><span style="font-family: 標楷體;">及其他藥品（如</span><span style="font-family: times new roman,serif;">propafenone</span><span style="font-family: 標楷體;">）抑制，使得病患原本快速代謝者因服用此類藥品而表現出緩慢代謝者的特性，因此大多數會被此酵素代謝的藥品，應探討其與</span><span style="font-family: times new roman,serif;">quinidine</span><span style="font-family: 標楷體;">的交互作用。</span><span style="font-family: times new roman,serif;"> </span></p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">３、其他藥品</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">其他特別可能與試驗用藥併用之藥品，除非藥動篩檢或交互作用篩檢可證明重要的交互作用並不存在，否則應研究其藥品交互作用。</span><span style="font-family: times new roman,serif;"> </span></p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">４、蛋白質結合試驗</span><span style="font-family: times new roman,serif;"> (Protein Binding Studies)<br /></span><span style="font-family: 標楷體;">會與血漿蛋白質大量結合的試驗用藥可能會將其他藥品由結合處取代之，如非類固醇類藥品</span><span style="font-family: times new roman,serif;">(NSAID's)</span><span style="font-family: 標楷體;">取代</span><span style="font-family: times new roman,serif;">warfarin</span><span style="font-family: 標楷體;">，反之亦然。這種交互作用可以由離體試驗簡便地觀察出來，若臨床曾觀察到交互作用，蛋白質結合試驗可以幫助了解此機制。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　</span> </p><p style="margin-left: 18pt;"><span style="font-family: 標楷體;">（二）併有疾病及併用藥品與交互作用篩檢</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　　若試驗用藥會用在特定併有疾病很可能發生的情況時，治療族群應包括併有其他疾病之病患，藥動篩檢可幫助決定併有疾病是否會影響試驗用藥之血中濃度，而臨床觀察則可以測出與其他疾病相關的特殊不良反應。同樣地，對於併用藥品，篩檢可幫助評估其他藥品是否會影響試驗用藥之藥動學特質。在某些經常併用其他藥品的情況下，應執行正式的交互作用試驗。例如不同類別的抗心絞痛藥品（</span><span style="font-family: times new roman,serif;">nitrate, beta-blocker, calcium-antagonist</span><span style="font-family: 標楷體;">）併用時，即應正式研究這些藥品的併用時之藥效和耐受性。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　　試驗用藥也可能會影響其他藥品的藥動學，關於此問題，第二種篩檢機制「交互作用篩檢」可能有所助益，如果第三階段臨床試驗包括使用多種其他藥品的病人，其他藥品之最低血中濃度可以在使用試驗用藥之前得到，也可以在試驗用藥達到穩定的血中濃度之後得到。因此應該可以測得試驗用藥對其他併用藥品的影響。執行上述試驗的障礙在於缺乏可信的測量其他藥品之血中濃度的方法。</span> </p><p><span style="font-family: 標楷體;">四、腎功能不全的影響</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　凡顯著經由腎臟排泄的藥品（原藥品或其活性代謝物）應定義腎功能改變對該藥品藥動學的影響。應有資料證實不同程度腎功能不全者的合理劑量調整說明。如要直接得到正確的肌氨酸酐清除率</span> <span style="font-family: times new roman,serif;">(creatinine clearance</span><span style="font-family: 標楷體;">簡稱</span><span style="font-family: times new roman,serif;">CCr)</span><span style="font-family: 標楷體;">，又不必讓病患住院以收集尿液，往往不大容易，因此在該藥品的仿單中，應標示</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">，其可用測定血中肌氨酸酐濃度依體重和年齡來計算。以下由</span><span style="font-family: times new roman,serif;">Cockcroft </span><span style="font-family: 標楷體;">和</span><span style="font-family: times new roman,serif;">Gault</span><span style="font-family: 標楷體;">所定的公式﹝</span><span style="font-family: times new roman,serif;">(Nephron 16:31-41 (1976)</span><span style="font-family: 標楷體;">﹞，是最常使用的。</span> </p><p><span style="font-family: 標楷體;">男性</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">　　＝　　體重</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">公斤</span><span style="font-family: times new roman,serif;">) x (140-</span><span style="font-family: 標楷體;">年齡</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">／</span><span style="font-family: times new roman,serif;">72 x Cr (</span><span style="font-family: 標楷體;">毫克</span><span style="font-family: times new roman,serif;">/100</span><span style="font-family: 標楷體;">毫升</span><span style="font-family: times new roman,serif;">)</span></p><p><span style="font-family: 標楷體;">女性</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">　　＝　　</span><span style="font-family: times new roman,serif;">0.85 </span><span style="font-family: 標楷體;">　</span><span style="font-family: times new roman,serif;">x</span><span style="font-family: 標楷體;">　體重</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">公斤</span><span style="font-family: times new roman,serif;">) x (140-</span><span style="font-family: 標楷體;">年齡</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">／</span><span style="font-family: times new roman,serif;">72 x Cr (</span><span style="font-family: 標楷體;">毫克</span><span style="font-family: times new roman,serif;">/100</span><span style="font-family: 標楷體;">毫升</span><span style="font-family: times new roman,serif;">)<br /></span><span style="font-family: 標楷體;">　　　　　　</span><span style="font-family: times new roman,serif;"> </span></p><p><span style="font-family: times new roman,serif;">Cr: serum creatinine</span></p><p><span style="font-family: 標楷體;">五、肝功能不全的影響</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　</span> <span style="font-family: 標楷體;">主要由肝臟代謝的藥品，尤其是經由氧化代謝或具活性代謝物者，使用於病患時，包括年老病患，應特別謹慎的，並應進行特別的藥動學試驗以探討肝功能降低所造成的影響，並尋找可能的藥品代謝或藥品交互作用之遺傳變異。然而，目前並無類似</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">之於腎功能的肝功能測定指標可預估藥品排泄之變異如何改變，不過當出現肝硬化時，表示藥品的清除率（如</span><span style="font-family: times new roman,serif;">theophylline</span><span style="font-family: 標楷體;">）可能會降低。在測量肝功能時，建議使用</span><span style="font-family: times new roman,serif;">FDA</span><span style="font-family: 標楷體;">基準中所推薦之</span><span style="font-family: times new roman,serif;">Child-Pugh</span><span style="font-family: 標楷體;">分類法及半乳糖單點法（</span><span style="font-family: times new roman,serif;">Galactose Single Point Method,GSP</span><span style="font-family: 標楷體;">。用於評估國人常見肝病病患殘餘肝功能</span><span style="font-family: times new roman,serif;">[residual liver function]</span><span style="font-family: 標楷體;">的方法），來定義肝功能及檢驗特殊代謝缺失對於新藥品藥動學的影響。（請參考本署制定之「肝功能不全病患的藥動學試驗基</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　準－臨床試驗設計、數據分析以及對劑量調整與標示的影響。」）</span> </p><p><span style="font-family: times new roman,serif;">&nbsp;</span></p><p><b><span style="font-family: 標楷體;">第四章、藥效</span></b><b><span style="font-family: times new roman,serif;">/</span></b><b><span style="font-family: 標楷體;">劑量</span></b><b><span style="font-family: times new roman,serif;">-</span></b><b><span style="font-family: 標楷體;">反應試驗</span></b><b><span style="font-family: times new roman,serif;"><br /></span></b><b><span style="font-family: 標楷體;">　　</span></b><span style="font-family: 標楷體;">由年齡相關的藥效差異</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">例如在某特定之藥品血中濃度，年齡對藥效或副作用之影響是加強或減低</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">，目前所知太少，因此無需特別在老年族群身上作常規的藥效或臨床試驗。從包含有年輕與年老病患的臨床試驗的觀察比全是老年人的臨床試驗，更可測得是否有重要的年齡差異。將病患以年齡分層，則可得到較敏感的評估，是最好的試驗方法。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　但在某些情況下，如鎮定劑、安眠藥和其他主要作用於中樞神經系統的藥品，則必須單獨施行老年族群臨床試驗。其他臨床試驗的分析結果有時也會顯示單獨需要年老病患試驗。這些指標包含界定藥效、不良反應的劑量</span><span style="font-family: times new roman,serif;">─</span><span style="font-family: 標楷體;">反應關係，尤其是最低有效劑量及較高劑量對中樞神經系統的影響等。必要時，亦須考慮執行特殊藥品與疾病的交互作用試驗。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　對於年輕與年老病患可能產生不同藥品反應之評估重點，應在於可能存在的藥動學差異，該藥動學的差異通常比已知之藥效學差異更為常見。大部分年老病患的用藥問題來自因年齡不同而產生之藥動學改變，或是與年齡相關的狀況如腎功能不全、心臟衰竭、使用多種藥品等。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　此外，藥動學差異較易察覺，一旦建立測量藥品及其代謝物的方法（此方法通常在藥品研發早期即已建立），評估受年齡相關的影響之技術即已存在。正式的藥動學試驗可以解釋特殊族群的疑問，而在第三階段臨床試驗執行「藥動篩檢」</span><span style="font-family: times new roman,serif;">(Pharmacokinetic screen)</span><span style="font-family: 標楷體;">更可以提高對於次要族群及個人之藥動學的偵測。於第三階段臨床試驗的病患中，僅採取少數的血樣決定藥品血中濃度，則可能測出個人的非典型的藥動學型態</span><span style="font-family: times new roman,serif;">(atypical pharmacokinetic behavior)</span><span style="font-family: 標楷體;">，例如</span><span style="font-family: times new roman,serif;">Encainide</span><span style="font-family: 標楷體;">的緩慢代謝者，另外，也可以測出次要族群中的之細微差異，例如不同年齡、性別、種族或具有特殊疾病、併用藥品等。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　新藥申請（</span><span style="font-family: times new roman,serif;">NDA, New Drug Application</span><span style="font-family: 標楷體;">）時，劑量反應、血中濃度反應資料是很重要的。對一個可測量的藥效指標如血壓、心室過早跳動率（</span><span style="font-family: times new roman,serif;">rate of ventricular premature beats</span><span style="font-family: 標楷體;">），是可預期從不同族群觀察到劑量反應，尤其這些差異對藥品的安全性、有效性有很重要的影響。但是，當藥效指標無法立刻從一個小族群評估時（例如治療憂鬱症、焦慮症），好的劑量反應資料則不易得到，在此小族群的次族群（例如老年人）則更甚。要測量不同次族群中的臨床療效或不良反應的差異是可能的，觀察到的差異可以反映藥動學差異或藥效學差異，例如對藥品不尋常的藥理反應。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　最後要強調藥動學評估之重要性的理由在於：務必先執行藥動學評估，方可正確地研判藥效學的差異性或相關性。當族群與血中濃度間有合理的相關性存在時，即可評估不同組間藥效學的差異性或是建立血中濃度與藥物反應之關係。因此必須有足夠的藥動學資料，讓試驗主持人藉此選擇足以在不同次族群中達到相當血中濃度的適當劑量，或是調整劑量到相似之血中濃度相似情況下，比較小組間的差異。</span> </p><p><span style="font-family: times new roman,serif;">&nbsp;</span></p><p><b><span style="font-family: 標楷體;">參考文獻</span></b> </p><p><span style="font-family: times new roman,serif;">1.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(1997). </span><span style="font-family: 標楷體;">藥品臨床試驗申請須知（台北）</span> </p><p><span style="font-family: times new roman,serif;">2.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(1999). </span><span style="font-family: 標楷體;">藥品查驗登記審查準則（台北）</span> </p><p><span style="font-family: times new roman,serif;">3.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2000). </span><span style="font-family: 標楷體;">藥品非臨床試驗安全性規範（台北）</span> </p><p><span style="font-family: times new roman,serif;">4.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2000). </span><span style="font-family: 標楷體;">臨床試驗基準（台北）</span> </p><p><span style="font-family: times new roman,serif;">5.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2000). </span><span style="font-family: 標楷體;">藥品非臨床試驗優良操作規範（台北）</span> </p><p><span style="font-family: times new roman,serif;">6.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2001). </span><span style="font-family: 標楷體;">肝功能不全病患的藥動學試驗基準（－臨床試驗設計、數據分析以及對劑量調整與</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　標示的影響）</span> </p><p><span style="font-family: times new roman,serif;">7.Guideline for the Study of Drugs, Likely To Be Used in the Elderly. FDA, USA, 1989.</span></p><p><span style="font-family: times new roman,serif;">8.ICH E7: Studies in Support of Special Populations: Geriatrics, 1993</span></p> 2013-12-04
1420495 藥政管理類,成藥及固有成方製劑管理辦法 法規命令 成藥及固有成方製劑管理辦法 <p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 1&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依藥事法第八條規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">成藥及固有成方製劑之管理，除藥事法另有規定者外，依本辦法之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 2&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法所稱成藥係指原料藥經加工調製，不用其原名稱，其摻入之麻醉藥藥品、毒劇藥品，不超過中央衛生主管機關所規定之限量，作用緩和、無積蓄性、耐久儲存、使用簡便，不待醫師指示即可供治療疾病之用者。</span> </p><p><span style="font-family: 新細明體,serif;">成藥分甲、乙兩類，其範圍及審核標準如基準表（附件一、二）。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 3&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">成藥中摻用麻醉藥品，除嗎啡含量應在千分之二以下，可卡因應在千分之一以下外，其他麻醉藥品摻用量由中央衛生主管機關比照上述標準視其劑量核定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 4&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">成藥中摻用毒劇藥品，如為中華藥典所載者，不得超過常用量三分之一，其未為中華藥典所載者，由中央衛生主管機關核定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 5&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法所稱固有成方係指我國固有醫藥習慣使用，具有療效之中藥處方，並經中央衛生主管機關選定公佈者而言。依固有成方調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">成之丸散、膏、丹稱為固有成方製劑。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 6&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">成藥及以批發或供人出售之固有成方製劑，應由藥品製造業者製造。中藥販賣業者得依固有成方所載之原名稱、成分、製法、效能、用法及用量，調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有成方製劑但以於其營業處所自行零售為限。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">審核及許可</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 7&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品製造業者調製成藥或固有成方製劑，應依藥事法第三十九條、第四十三條、第四十六條至第四十八條、第五十六條及第五十七條之規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 8&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">成藥依成藥基準表審核之，但含藥酒類依其有關規定辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 9&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥販賣業者調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有成方製劑，應列具名稱、成分、製法、效能、用法及用量，連同有關資料證件，向該管直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關提出申請，經核准登記發給登記證後，始得製售。</span> </p><p><span style="font-family: 新細明體,serif;">前項經核准發給登記證案件，直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關應按月列冊報請中央衛生主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 10&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中藥販賣業者調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有成方製劑，應於其管理藥品之中醫師監督下為之。但不含毒劇藥品者，可由確具中藥基本知識及鑑別能力人員自行調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 11&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">固有成方製劑不得摻入防腐劑、色素、人工甘味劑、化學溶劑及其他有害添加物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">成藥之標籤、仿單或包裝應標明甲類成藥或乙類成藥。固有成方製劑應標明名稱及固有成方字樣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">販賣之管理</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品製造業者除含藥酒類不得以留置方式供銷家庭用戶外，得將自製之成藥或固有成方製劑，以留置方式直接供銷家庭用戶。但以供銷民眾購用藥品較為不便之偏僻地區為限。</span> </p><p><span style="font-family: 新細明體,serif;">家庭留置成藥或固有成方製劑之地區，應由直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關每年查核一次，逐步縮減留置地區範圍。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">藥品製造業者將自製成藥或固有成方製劑留置於家庭用戶者，應依左列各款之規定：</span> </p><p><span style="font-family: 新細明體,serif;">一、申請供銷家庭留置成藥或固有成方製劑，應事先檢具藥品名清單</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">二份，申請直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關，轉報中央衛生主管機關核定。</span> </p><p><span style="font-family: 新細明體,serif;">二、供銷留置成藥或固有成方製劑之日起十五日內開具左列事項，向直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關報備：</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">藥品製造業者之名稱、地址及負責人姓名。</span> </p><p><span style="font-family: calibri;">&nbsp;(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">銷售地區</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">列明直轄市、縣市、鄉鎮市區或村里名稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">及留置成藥或固有成方製劑服務員名冊</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">一份。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">留置藥品清單一份。</span> </p><p><span style="font-family: 新細明體,serif;">三、留置之成藥或固有成方製劑應裝置在「家庭藥品留置袋」或「箱」內，其袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應採堅固耐用材料製成，並應載明藥品製造業者</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">藥商</span><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">名稱、地址與留置藥品之品名、許可字號、效能、價格、數量及注意事項等</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。但所刊載文字圖畫，不得有藥事法第六十八條所列各款情事。</span> </p><p><span style="font-family: 新細明體,serif;">四、應發給留置成藥或固有成方製劑服務人員服務證</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">格式如附件六</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，並指定其服務員勤予巡檢留置之藥品，每次間隔不得逾三個月。</span> </p><p><span style="font-family: 新細明體,serif;">附件三</span><span style="font-family: calibri;">&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">藥品製造廠商名稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">家庭留置成藥固有成方製劑品名清單</span> </p><p><span style="font-family: 新細明體,serif;">┌────┬───────┬───┬────┬────┬───┐</span> </p><p><span style="font-family: 新細明體,serif;">│許可字號│藥</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">品</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">名</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">稱│劑</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">型│包括容量│核准效能│備</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">考│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">字│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">└────┴───────┴───┴────┴────┴───┘</span> </p><p><span style="font-family: 新細明體,serif;">註：</span> </p><p><span style="font-family: 新細明體,serif;">一、申請直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關轉報中央主管機關核定及向直轄</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關報備之清單均依此格式。</span> </p><p><span style="font-family: 新細明體,serif;">二、向縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市、局</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關報備之品名清單，須在備考欄註明核定</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">機關名稱及文號。</span> </p><p><span style="font-family: calibri;">&nbsp;(</span><span style="font-family: 新細明體,serif;">備</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">註：附件三之註一請參閱行政院公報第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">卷</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">期</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">頁</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;">&nbsp;(</span><span style="font-family: 新細明體,serif;">備</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">註：附件三～六請參閱中華民國現行法規彙編</span><span style="font-family: calibri;"> (83</span><span style="font-family: 新細明體,serif;">年</span><span style="font-family: calibri;">5</span><span style="font-family: 新細明體,serif;">月版</span><span style="font-family: calibri;">) (</span></p><p><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">三○</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20905</span><span style="font-family: 新細明體,serif;">～</span><span style="font-family: calibri;">20909 </span><span style="font-family: 新細明體,serif;">頁</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">家庭留置成藥或固有成方製劑之服務員，於推銷或執行工作時，應配帶服務證，指導用戶將藥品留置袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">置於不被日晒、雨淋、受潮及不易為兒童獲取之處所。如發現袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">內藥品有變質、沉澱、損壞或其他不良狀況時，應即收回或換入新品。並不得將任何成藥或固有成方製劑拆封或改裝及沿途或設攤販賣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">乙類成藥得由百貨店、雜貨店及餐旅服務商兼營零售之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 17 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">兼營零售乙類成藥者應依左列各款之規定：</span> </p><p><span style="font-family: 新細明體,serif;">一、對內服及外用成藥，應各別專設櫥櫃陳列，妥善貯藏。但含藥酒類不在此限。</span> </p><p><span style="font-family: 新細明體,serif;">二、商號或招牌不得使用藥商名稱或易被誤認為藥商之字樣。</span> </p><p><span style="font-family: 新細明體,serif;">三、不得設置藥品推銷員及本辦法所稱之服務員。</span> </p><p><span style="font-family: 新細明體,serif;">四、不得將成藥拆除包裝零售。</span> </p><p><span style="font-family: 新細明體,serif;">五、不得買賣來源不明之成藥。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">四</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">檢查及取締</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 18 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關對於成藥及固有成方製劑之檢查或抽驗，除依藥事法有關規定辦理外，並得派員檢查或抽驗留置於家庭用戶之成藥、固有成方製劑及其裝置用袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">箱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 19 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反本辦法之規定或涉及偽藥、劣藥、禁藥者，依藥事法有關規定處理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">章</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp; 20 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6052&type=0
1420496 其他類,血液製劑條例 法律 血液製劑條例 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為提昇血液製劑之安全與品質及確保其穩定供應，以維護國民健康，特制定本條例。本條例未規定者，依醫療法、藥事法及其他相關法律之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本條例所稱主管機關：在中央為行政院衛生署；在直轄市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本條例所稱血液製劑，指以人類血液經加工調製，製成一定劑型及劑量之藥品。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">血液製劑原料，應以國內捐血而得。但國內原料供應不足時，血液製劑製造業者得經中央主管機關核准，自國外輸入。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">主管機關為達到血液製劑之國內自製自給，應積極推行捐血教育及宣導措施，鼓勵民眾捐血。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關為確保血液製劑安全、品質及穩定供應，並促進血液製劑安全性技術之研發及發展國內血液製劑產業，應訂定血液製劑發展方案。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構應致力推展捐血工作，提昇血液製劑原料安全，協助確保穩定供應及採行保護捐血者健康措施。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">血液製劑製造業者，應符合藥品優良製造規範，提供安全及優良品質之血液製劑。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構、醫師使用血液製劑時，應優先使用國內捐血製造之血液製劑，並提供病人血液製劑之用藥資訊。</span> </p><p><span style="font-family: 新細明體,serif;">為尊重病人使用之意願，以其他原料、方法或基因工程所製成之製劑，使用時不受前項規定之限制。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構應訂定年度採集血液計畫，包括捐血量、醫療用血量、供血液製劑製造之原料血量及辦理推展捐血事宜，報請中央主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">血液製劑製造、輸入業者，應定期將其預估及實際製造或輸入之血液製劑數量，報請中央主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應訂定年度血液製劑預估需求計畫，並公告之。</span> </p><p><span style="font-family: 新細明體,serif;">前項年度預估需求計畫，應包括下列事項：</span> </p><p><span style="font-family: 新細明體,serif;">一、血液製劑之種類。</span> </p><p><span style="font-family: 新細明體,serif;">二、年度所需製造與輸入血液製劑之種類及目標量。</span> </p><p><span style="font-family: 新細明體,serif;">三、血液製劑製造之目標量所需血液原料量。</span> </p><p><span style="font-family: 新細明體,serif;">四、血液製劑之替代性醫藥品量。</span> </p><p><span style="font-family: 新細明體,serif;">五、其他有關血液原料有效利用事項。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構對於所採集之血液原料，得自為血液製劑製造業者或經中央主管機關核准後，提供其他血液製劑製造業者。</span> </p><p><span style="font-family: 新細明體,serif;">捐血機構提供其他血液製劑製造業者，得收取工本費用；其費額，應報中央主管機關核准。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構採集血液應對捐血者實施健康篩檢。</span> </p><p><span style="font-family: 新細明體,serif;">捐血者健康要件之標準及前項健康篩檢之項目，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構於必要時，應提供血液製劑製造業者相關血液原料之採集時間、檢驗項目與結果及捐血者資料等必要資訊，以防止血液原料發生健康危害。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第十條、第十一條規定者，由中央主管機關處新臺幣二萬元以上十萬元以下罰鍰，並令其限期改善，屆期未改善者，按次連續處罰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本條例所處之罰鍰，經限期繳納，屆期未繳納者，依法移送強制執行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本條例施行細則，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本條例自公布後一年施行。</span> </p> 2013-12-04
1420497 其他類,血液製劑條例施行細則 法規命令 血液製劑條例施行細則 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本細則依血液製劑條例</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本條例</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第十八條規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本條例第四條所稱血液製劑原料，應以國內捐血而得，指國內製造業者製造血液製劑，供應國內使用者，應以國內捐血為其之主要原料來源。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">血液製劑製造業者依本條例第四條規定向中央主管機關申請自國外輸入血液製劑原料，應檢具下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一、申請輸入血液製劑原料報告書，包括下列事項：</span> </p><p><span style="font-family: calibri;">&nbsp;(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國內血液製劑原料供應不足分析。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">擬輸入血液製劑原料總量。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">擬輸入血液製劑原料來源國名及該國許可輸出之證明。</span> </p><p><span style="font-family: calibri;">&nbsp;(</span><span style="font-family: 新細明體,serif;">四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">擬製造血液製劑種類及數量。</span> </p><p><span style="font-family: 新細明體,serif;">二、藥品專案進口申請書。</span> </p><p><span style="font-family: 新細明體,serif;">三、藥品製造許可證影本。</span> </p><p><span style="font-family: 新細明體,serif;">四、血液製劑原料檢驗規格書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">國外輸入之血液製劑原料，不得與國內捐血所得之原料混用。</span> </p><p><span style="font-family: 新細明體,serif;">國內血液製劑產品，應於標籤仿單及包裝明顯標示原料來源，並區分國內、國外原料來源，為不同之包裝。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構應依本條例第十條規定，於每年七月三十一日前提出次年度之採集血液計畫，報請中央主管機關備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">血液製劑製造業者及血液製劑輸入業者，應依本條例第十一條規定，於每年一月及七月將下列事項報請中央主管機關備查：</span> </p><p><span style="font-family: 新細明體,serif;">一、未來六個月</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">含報告當月</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製造或輸入之血液製劑預估數量。</span> </p><p><span style="font-family: 新細明體,serif;">二、前六個月</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">不含報告當月</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">實際製造或輸入之血液製劑數量。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關依本條例第十二條規定訂定年度血液製劑預估需求計畫，應於前一年十二月三十一日前公告。</span> </p><p><span style="font-family: 新細明體,serif;">前項年度血液製劑預估需求計畫得以一至三年為期訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">捐血機構依本條例第十三條第一項規定，將所採集之血液原料提供其他血液製劑製造業者，應檢具該血液製劑製造業者之藥品製造許可證影本，並載明血液原料提供數量，申請中央主管機關核准；變更時，亦同。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本細則自本條例施行之日施行。</span> </p> 2013-12-04
1420498 查驗登記類,西藥及醫療器材查驗登記審查費收費標準 行政解釋 西藥及醫療器材查驗登記審查費收費標準 <p>第一條　本標準依藥事法第一百零四條之二第二項規定訂定之。&nbsp; <br />第二條&nbsp; 西藥及醫療器材辦理查驗登記者，每件應繳納之審查費如下： </p><p>一、新藥 </p><p>（一）新成分製劑之藥品查驗登記，新臺幣六十萬元。 </p><p>（二）新療效複方或新使用途徑製劑之藥品查驗登記，新臺幣五萬元。 </p><p>（三）國內新設工廠或新劑型設立查核，新臺幣二萬元。 </p><p>（四）國外製藥工廠資料備查，新臺幣二萬元。 </p><p>（五）新劑型、新使用劑量、新單位含量或控釋劑型、相同成分相同投與途徑不同劑量之新成分新藥等製劑產品之查驗登記，新臺幣三萬五千元。 </p><p>二、一般製劑 </p><p>（一）監視藥品之學名藥品查驗登記，新臺幣三萬五千元。 </p><p>（二）非屬監視藥品之學名藥品查驗登記，新臺幣二萬元。 </p><p>（三）國內新設工廠或新劑型設立查核，新臺幣二萬元。 </p><p>（四）國外製藥工廠資料備查，新臺幣二萬元。 </p><p>（五）外銷專用藥品查驗登記，新臺幣二萬元。 </p><p>三、生物藥品 </p><p>（一）血液製劑、抗毒素或疫苗查驗登記，新臺幣六十萬元。 </p><p>（二）利用基因工程製造之藥品查驗登記，新臺幣六十萬元。 </p><p>（三）國內新設工廠或新劑型設立查核，新臺幣二萬元。 </p><p>（四）國外製藥工廠資料備查，新臺幣二萬元。 </p><p>（五）已審查過之生物藥品，其不同劑量包裝、不同產地之查驗登記，新臺幣三萬五千元。 </p><p>四、臨床試驗 </p><p>（一）臨床試驗計畫書審核，新臺幣一萬五千元。 </p><p>（二）臨床試驗報告書查核，新臺幣一萬五千元。 </p><p>（三）銜接性試驗評估，新臺幣一萬五千元。 </p><p>（四）臨床試驗相關函詢，新臺幣一千五百元。 </p><p>五、生體可用率及生體相等性試驗 </p><p>（一）生體可用率試驗計畫書審核，新臺幣五千元。 </p><p>（二）生體相等性試驗計畫書審核，新臺幣五千元。 </p><p>（三）非監視成分之生體可用率試驗報告書審核，新臺幣一萬五千元。 </p><p>（四）非監視成分之生體相等性試驗報告書審核，新臺幣一萬五千元。 </p><p>（五）非監視成分口服劑型藥品之溶離率曲線比對報告書審核，新臺幣五千元。 </p><p>六、原料藥 </p><p>（一）供藥廠製造藥品之原料藥查驗登記，新臺幣三萬元。 </p><p>（二）輸入自用原料藥備查，新臺幣一千五百元。 </p><p>（三）輸入試製藥品原料藥備查，新臺幣一千五百元。 </p><p>七、醫療器材 </p><p>（一）新原理、新結構、新材料、新效能或經中央衛生主管機關審查認定屬新醫療器材之查驗登記，新臺幣三萬元。 </p><p>（二）一般及外銷專用醫療器材查驗登記，新臺幣一萬元。 </p><p>（三）醫療器材列管查核，新臺幣一千五百元。 </p><p>（四）國內醫療器材製造工廠查核或其後續稽核，新臺幣二萬元。 </p><p>（五）國外醫療器材製造工廠品質系統文件審查或其後續稽核，新臺幣二萬元。 </p><p>（六）優良醫療器材製造工廠認可登錄增加登錄品項或遷廠之變更，新臺幣二萬元。 </p><p>（七）優良醫療器材製造工廠認可登錄之其他變更，新臺幣八千元。 </p><p>（八）第一等級體外診斷試劑備查函，新臺幣一千五百元。 </p><p>（九）第三等級體外診斷試劑查驗登記（新增品項），新臺幣五萬元。 </p><p>（十）第三等級體外診斷試劑查驗登記（類似品項），新臺幣三萬五千元。 </p><p>（十一）醫療器材半成品備查，新臺幣一千五百元。 </p><p>八、藥品登記事項變更 </p><p>（一）新適應症、新用法用量、新類別或新賦形劑變更，新臺幣一萬二千元。 </p><p>（二）委託製造、移轉、合併、產地或遷廠變更，新臺幣八千元。 </p><p>（三）前目以外之其它變更，新臺幣五千元。 </p><p>九、醫療器材登記事項變更 </p><p>（一）增加新適用範圍變更，新臺幣一萬二千元。 </p><p>（二）增加規格、移轉、合併、產地或遷廠變更，新臺幣八千元。 </p><p>（三）其它變更或申請委託包裝，新臺幣五千元。 </p><p>（四）許可證、標籤或仿單之遺失補發，新臺幣五千元。 </p><p>十、藥物原核准許可證有效期間展延，新臺幣三千元。 </p><p>十一、證明書及備查函 </p><p>（一）中文產地證明書，新臺幣一千五百元。 </p><p>（二）英文產地證明書，新臺幣一千五百元。 </p><p>（三）中文優良藥品製造證明書，新臺幣一千五百元。 </p><p>（四）英文優良藥品製造證明書，新臺幣一千五百元。 </p><p>（五）中文優良醫療器材製造證明書，新臺幣一千五百元。 </p><p>（六）英文優良醫療器材製造證明書，新臺幣一千五百元。 </p><p>（七）中文備查函證明，新臺幣一千五百元。 </p><p>（八）英文備查函證明，新臺幣一千五百元。 </p><p>十二、藥物許可證領證，新臺幣一千五百元。 </p><p>十三、案件函詢，新臺幣一千五百元。 </p><p>十四、國外藥品製造工廠實地查核 </p><p>（一）工廠資料經衛生署准予備查者， 新臺幣五十萬元。 </p><p>（二）工廠資料未經衛生署准予備查者，新臺幣五十六萬元。 </p><p>十五、國外醫療器材製造工廠實地查核 </p><p>（一）實地查核或其後續稽核，新臺幣五十萬元。 </p><p>（二）增加登錄品項之查核，新臺幣五十萬元。 </p><p>（三）遷廠之查核，新臺幣五十萬元。 </p><p>前項第八款第二目及第九款第二目之變更申請，每件以一廠次為限。 </p><p>第一項第十一款證明書及備查函之申請，每件以一式五份為限。 </p><p>第一項第十四款，每件每增加一劑型之收費如下： </p><p>一、非無菌製劑之同一廠房、空調、水系統，加收新臺幣三萬五千元。 </p><p>二、非無菌製劑之同一廠房不同空調或水系統，加收新臺幣五萬元。 </p><p>三、無菌製劑之同一廠房不同空調或水系統，加收新臺幣八萬八千元。 </p><p>四、非無菌製劑之同一廠房不同空調系統且不同水系統，加收新臺幣七萬元。 </p><p>五、無菌製劑之同一廠房不同空調系統且不同水系統，加收新臺幣十萬五千元。 </p><p>六、非無菌製劑之不同廠房，加收新臺幣十萬五千元。 </p><p>七、無菌製劑之不同廠房，加收新臺幣十萬五千元。 </p><p>第一項第十五款，每件每增加一醫療器材品項製程之收費如下： </p><p>一、同一廠房，加收新臺幣三萬五千元。 </p><p>二、不同廠房，加收新臺幣十萬五千元。 </p><p>第一項第十五款，每件每增加一不同滅菌製程，加收新臺幣十萬五千元。 </p><p>第一項第一款第一目、第三款第一目及第二目自中華民國九十六年一月一日施行。 <br />&nbsp;<br />第三條&nbsp; 辦理本標準第二條第十四款及第十五款之查核人員臨場費，應比照國外出差旅費報支要點所定標準，由中央衛生主管機關向被查核者收取。 <br />&nbsp;<br />第四條　本標準除已另定施行日期者外，自發布日施行。 </p><p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </p> 2013-12-04
1420499 罕見疾病類,罕見疾病防治及藥物法 法律 罕見疾病防治及藥物法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">為防治罕見疾病之發生，及早診斷罕見疾病，加強照顧罕見疾病病人，協助病人取得罕見疾病適用藥物及維持生命所需之特殊營養食品，並獎</span> <span style="font-family: 新細明體,serif;">勵與保障該藥物及食品之供應、製造與研究發展，特制定本法。</span> </p><p><span style="font-family: 新細明體,serif;">本法未規定者，適用其他有關法律之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱主管機關：在中央為行政院衛生署；在直轄市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱罕見疾病，係指疾病盛行率在中央主管機關公告基準以下或因情況特殊，經第四條所定委員會審議認定，並經中央主管機關指定公告者。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱罕見疾病藥物，係指依本法提出申請，經第四條所定委員會審議認定，並經中央主管機關公告，其主要適應症用於預防、診斷、治療罕見疾病者。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱維持生命所需之特殊營養食品，係指經第四條所定委員會審議認定，並經中央主管機關公告，主要適用於罕見疾病病人營養之供應者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關為審議罕見疾病有關事項，應設罕見疾病及藥物審議委員會</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">以下簡稱委員會</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，其組織及會議，依中央主管機關之規定。</span> </p><p><span style="font-family: 新細明體,serif;">委員會委員，由政府機關代表、醫事學者專家及社會公正人士組成，其中委員名額，至少應有三分之二以上為醫事學者專家。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">委員會任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一、罕見疾病認定之審議及防治之諮詢。</span> </p><p><span style="font-family: 新細明體,serif;">二、罕見疾病藥物及維持生命所需之特殊營養食品認定之審議。</span> </p><p><span style="font-family: 新細明體,serif;">三、罕見疾病藥物查驗登記之審議。</span> </p><p><span style="font-family: 新細明體,serif;">四、罕見疾病藥物及維持生命所需之特殊營養食品補助及研發之審議。</span> </p><p><span style="font-family: 新細明體,serif;">五、罕見疾病國際醫療合作之審議、協助及諮詢。</span> </p><p><span style="font-family: 新細明體,serif;">六、治療特定疾病之非罕見疾病藥物之審議。</span> </p><p><span style="font-family: 新細明體,serif;">七、其他與罕見疾病有關事項之諮詢。</span> </p><p><span style="font-family: 新細明體,serif;">委員會執行前項任務，應徵詢其他相關學者專家、產業或罕見疾病病人代表之意見。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應辦理罕見疾病之防治與研究。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫事人員發現罹患罕見疾病之病人或因而致死者，應向中央主管機關報告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關接獲前條報告或發現具有罕見遺傳疾病缺陷者，經病人或其法定代理人同意，得派遣專業人員訪視，告知相關疾病之影響，並提供照護諮詢。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">從事前二條業務之機關、機構、團體及其人員，應注意執行之態度及方法，尊重病人之人格與自主，並維護其隱私與社會生活之經營。</span> </p><p><span style="font-family: 新細明體,serif;">前項人員，因業務知悉或持有之罕見疾病資料，應予保密，不得無故洩漏或交付。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應獎勵各級醫療或研究機構從事罕見疾病防治工作，補助相關人力培育、研究及設備所需經費。</span> </p><p><span style="font-family: 新細明體,serif;">前項規定，直轄市、縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關得準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">主管機關應辦理罕見疾病之教育及宣導，並由機關、學校、團體及大眾傳播媒體協助進行。</span> </p><p><span style="font-family: 新細明體,serif;">主管機關於罕見疾病病人發生就學、就業或就養問題時，得協調相關機關</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">構</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">協助之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">罕見疾病病人或其法定代理人得備具申請書、第十條規定之醫療或研究機構出具之證明書、診療計畫書及相關證明文件，向中央主管機關提出申請，經委員會審議通過後，中央主管機關得提供補助至國外進行國際醫療合作。</span> </p><p><span style="font-family: 新細明體,serif;">前項醫療合作為代行檢驗項目者，得由第十條規定之醫療或研究機構申請補助。</span> </p><p><span style="font-family: 新細明體,serif;">前二項補助之申請程序、應備之書證資料及其他應遵行事項之辦法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">除本法另有規定外，罕見疾病藥物非經中央主管機關查驗登記，並發給藥物許可證，不得製造或輸入。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">主要適應症用於預防、診斷或治療罕見疾病者，得申請查驗登記為罕見疾病藥物。</span> </p><p><span style="font-family: 新細明體,serif;">前項申請查驗登記應備之書證資料、審查程序及相關事項之準則，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請罕見疾病藥物查驗登記者，中央主管機關於必要時，得要求其進行國內臨床試驗，並應對臨床試驗之申請內容及結果予以適當之公開說明。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">罕見疾病藥物依本法查驗登記發給藥物許可證者，其許可證有效期間為十年。有效期間內，中央主管機關對於同類藥物查驗登記之申請，應不予受理。</span> </p><p><span style="font-family: 新細明體,serif;">前項罕見疾病藥物於十年期滿後仍須製造或輸入者，應事先申請中央主管機關核准展延，每次展延不得超過五年。展延期間，同類藥物得申請中央主管機關查驗登記。</span> </p><p><span style="font-family: 新細明體,serif;">罕見疾病藥物依本法查驗登記發給許可證後，如經中央主管機關公告不再列屬罕見疾病藥物者，其許可證之展延，適用藥事法有關規定。</span> </p><p><span style="font-family: 新細明體,serif;">依第一項規定取得許可證之所有人於特許時間內擬停止製造或輸入罕見疾病藥物者，應於停止日前六個月以書面通知中央主管機關。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">有下列情形之一者，中央主管機關得不受前條第一項規定之限制，受理其他同類藥物之查驗登記申請，並發給許可證：</span> </p><p><span style="font-family: 新細明體,serif;">一、新申請人取得經查驗登記許可為罕見疾病藥物之權利人授權同意。</span> </p><p><span style="font-family: 新細明體,serif;">二、具相同適應症且本質類似之罕見疾病藥物之新申請案，其安全性或有效性確優於已許可之罕見疾病藥物。</span> </p><p><span style="font-family: 新細明體,serif;">三、持有罕見疾病藥物許可證者無法供應該藥物之需求。</span> </p><p><span style="font-family: 新細明體,serif;">四、罕見疾病藥物售價經中央主管機關認定顯不合理。</span> </p><p><span style="font-family: 新細明體,serif;">依前項第二款至第四款規定經中央主管機關查驗登記發給許可證者，適用前條之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">罕見疾病藥物未經查驗登記或有前條第一項第三款、第四款情形之一</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">者，政府機關、醫療機構、罕見疾病病人與家屬及相關基金會、學會、</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">協會，得專案申請中央主管機關許可。但不得作為營利用途。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項專案申請，中央主管機關於必要時，得委託或指定相關機構或團</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">體辦理。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前二項專案申請應備之書證資料、審查程序及其他應遵行事項之辦</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">法，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">罕見疾病藥物經認定有危害人體健康之情事或有危害之虞者，中央主</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">管機關得命藥商或專案申請者於期限內回收。必要時，並得廢止該藥</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">物之許可。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">經依本法核准上市或專案申請之罕見疾病藥物，應由中央主管機關編</span><span style="font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">列年報，載明其使用數量、人數、不良反應及其他相關報告等資料。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">藥商及專案申請者應提供相關資料，配合前項年報之辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">非罕見疾病藥物依藥事法規定製造或輸入我國確有困難，且經委員會</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">審議認定有助於特定疾病之醫療者，準用本法有關查驗登記及專案申</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">請之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">罕見疾病及藥物之認定、許可、撤銷及廢止，中央主管機關應定期公</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">告之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法申請查驗登記、臨床試驗、許可證之核發、展延或專案申請者，</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">應繳納審查費、登記費或證照費；其費額，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">主管機關得獎勵罕見疾病藥物或維持生命所需之特殊營養食品之供</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">應、製造及研究發展；其獎勵對象、方式或被獎勵者應遵循事項之辦</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">法，由主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">擅自製造、輸入未經許可之罕見疾病藥物者，或明知未經許可之罕見</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">疾病藥物，而販賣、供應、調劑、運送、寄藏、牙保、轉讓或意圖販</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">賣而陳列者，依藥事法第八十二條、第八十三條規定處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第十六條規定者，處新台幣三萬元以上十五萬元以下罰鍰；其情</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">節重大者，藥商於二年內不得再申請該藥物之查驗登記，並得處醫療</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">機構一個月以上一年以下停業處分。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">申請罕見疾病藥物查驗登記或展延登記，提供不實之書證資料者，處</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">新台幣二萬元以上十萬元以下之罰鍰，二年內不得再申請該藥物之查</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">驗登記；其已領取該藥物許可證者，撤銷之；其涉及刑責者，移送司</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">法機關辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第十九條第一項規定，將專案申請之罕見疾病藥物充作營利用途</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">者，處新台幣三萬元以上十五萬元以下罰鍰；其獲取之利益，沒入之；</span><span style="font-family: calibri;">&nbsp;&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">二年內並不得再行提出罕見疾病藥物之專案申請。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反主管機關依第二十條規定令其限期回收之命令者，處新台幣三萬</span><span style="font-family: calibri;">&nbsp; </span></p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">元以上十五萬元以下罰鍰，並按次連續處罰至回收為止。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">違反第二十一條第二項規定，藥商處新台幣一萬元以上五萬元以下之</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">罰鍰；專案申請者，其再申請罕見疾病藥物，中央主管機關得不予許</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">可。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所定之罰鍰，由主管機關處罰之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">前項罰鍰經限期繳納，屆期未繳納者，依法移送強制執行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應編列預算，補助罕見疾病預防、篩檢、研究之相關經</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">費及</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">依全民健康保險法依法未能給付之罕見疾病診斷、治療、藥物與維持</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">生命所需之特殊營養品、居家醫療照護器材費用。其補助方式、內容</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">及其他相關事項之辦法，由中央主管機關定之。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;</span><span style="font-family: 新細明體,serif;">前項補助經費，得由菸品健康福利捐之分配收入支應或接受機構、團</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">體之捐助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">醫療機構得專案申請輸入罕見疾病病人維持生命所需之特殊營養食</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">品；其應備之書證資料、申請審查程序及其他應遵行事項之辦法，由</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法施行細則，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法自公布日起六個月施行。</span> </p><p><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">本法修正條文自公布日施行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-04
1420500 罕見疾病類,罕見疾病防治及藥物法施行細則 法規命令 罕見疾病防治及藥物法施行細則 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本細則依罕見疾病防治及藥物法</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第三十五條規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法所稱罕見疾病病患維持生命所需之特殊營養食品，其品目及適用之疾病，由中央主管機關公告之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第三條第一項所稱疾病盛行率，指中央主管機關參照醫事人員依本法第七條規定報告之資料及全民健康保險就醫資料所計算之疾病年盛行率。</span> </p><p><span style="font-family: 新細明體,serif;">中央主管機關對於前項疾病盛行率之公告標準，至少每三年檢討一次。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第三條第一項所稱情況特殊，指疾病盛行率超過中央主管機關公告標準，或難以計算，而其診斷治療所需之方法或藥物取得確有困難，經中央主管機關依本法第四條規定設置之罕見疾病及藥物審議委員會認定者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法第七條規定負有報告義務之醫事人員，應於發現罕見疾病患者或屍體之日起一個月內，向中央主管機關陳報。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應將罕見疾病人口之變遷資料，納入衛生統計。</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第八條所稱優生保健諮詢中心，指經中央主管機關委託，辦理罕見遺傳疾病防治、研究及優生保健諮詢服務之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央及直轄市主管機關依本法第十一條規定辦理罕見疾病之防治教育與宣導，應協同教育、社政及新聞主管機關訂定計畫，據以實施。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關對於依本法第十三條第一項規定協助至國外進行國際醫療合作者，得比照全民健康保險緊急傷病自墊醫療費用核退辦法所定核退標準，予以補助。</span> </p><p><span style="font-family: 新細明體,serif;">本法第十三條第二項所稱代行檢驗項目，以對疾病治療方式或遺傳諮詢建議有重大影響者為限；中央主管機關對其補助之額度，比照全民健康保險醫療費用支付標準之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">下列藥物，為本法第十七條第一項、第二項及第十八條第一項所稱之同類藥物：</span> </p><p><span style="font-family: 新細明體,serif;">一、有效成分及適應症與依本法查驗登記發給許可證之一般化學藥物相同者，包括其結構上之異構物、錯化物、鹽類、酯類、螯合物或其他非共價鍵衍生物。</span> </p><p><span style="font-family: 新細明體,serif;">二、主分子結構及適應症與依本法查驗登記發給許可證之生物製劑或大分子藥物相同者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第十八條第一項第一款所稱罕見疾病藥物之權利人，指領有罕見疾病藥物許可證者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依本法第十八條第一項第二款規定向中央主管機關申請查驗登記者，應檢附足以證明該新申請罕見疾病藥物之安全性或有效性優於已許可之罕見疾病藥物之資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法第十八條第一項第三款所稱無法供應該藥物之需求，指權利人未能充分供應該罕見疾病藥物，經中央主管機關令其限期改善，屆期仍未改善者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關依本法第十八條第一項第四款規定為罕見疾病藥物售價合理與否之認定時，應參考新申請人及權利人檢送之售價分析資料、中央健康保險局公告之藥價基準及其他相關資料為之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本法及本細則所定文書格式，由中央主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本細則自中華民國八十九年八月九日施行。</span> </p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6055&type=0
1420501 罕見疾病類,罕見疾病藥物,罕見疾病藥物供應製造及研究發展獎勵辦法 法規命令 罕見疾病藥物供應製造及研究發展獎勵辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 1&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依罕見疾病防治及藥物法第二十五條規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 2&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">具有下列情形之一者，得依本辦法申請獎勵：</span> </p><p><span style="font-family: 新細明體,serif;">一、引進罕見疾病藥物、或將罕見疾病藥物列入處方集、或專案申請罕見疾病藥物，對罕見疾病藥物之供應，著有貢獻者。</span> </p><p><span style="font-family: 新細明體,serif;">二、製造符合國內需求、本土特有、不易進口、當時無法充分供應或其售價顯不合理之罕見疾病藥物，嘉惠病患，著有效益者。</span> </p><p><span style="font-family: 新細明體,serif;">三、在國內自行研發新罕見疾病藥物，經取得國內、外之專利</span> <span style="font-family: 新細明體,serif;">或授權，或取得國內、外新罕見病藥物之專利或授權，並在國內進行臨床試驗研究，對罕見疾病藥物之研究發展，著有成效者。</span> </p><p><span style="font-family: 新細明體,serif;">四、其他對罕見疾病藥物之供應、製造及研究發展，有特殊貢獻者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 3&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">獎勵方式以頒發獎金為之，但情形特殊者，得改予或併予其他獎勵。</span> </p><p><span style="font-family: 新細明體,serif;">頒發獎金之額度及其他獎勵方式，由中央主管機關視年度預算、相關經費及實際需要另定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 4&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">獎勵以每年定期辦理一次為原則。</span> </p><p><span style="font-family: 新細明體,serif;">符合第二條所定資格者，得於規定期限內，逕向中央主管機關申請獎勵；相關之公會、團體，亦得薦請中央主管機關核予獎勵。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 5&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">獎勵案件應先提交罕見疾病及藥物審議委員會審議後，再行陳請中央主管機關核定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 6&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">相同之研究或發明分別申請獎勵時，應就最先提出申請者獎勵之。二個以上獎勵對象就同一事實共同申請獎勵時，所獲得之獎勵應由全體申請人所共有。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 7&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">所需獎勵經費，由中央主管機關編列預算支應，並得接受團體、單位或個人之捐助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 8&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">被獎勵者所提供事蹟若有虛偽不實，由中央主管機關予以撤銷獎勵並追回獎勵金。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 9&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自中華民國八十九年八月九日施行。</span> </p><p><span style="font-family: calibri;">&nbsp;</span></p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6065&type=0
1420502 罕見疾病類,罕見疾病藥物,罕見疾病藥物專案申請辦法 法規命令 罕見疾病藥物專案申請辦法 <p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 1&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法依罕見疾病防治及藥物法</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第十九條第三項及第二十二條規定訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 2&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">罕見疾病藥物未經查驗登記，或持有許可證者無法供應，或該藥物售價經中央主管機關認定顯不合理時，其製造或輸入得由政府機關、醫療機構、罕見疾病病人與家屬及相關基金會、學會、協會，依本法第十九條第一項規定，專案申請中央主管機關許可。</span> </p><p><span style="font-family: 新細明體,serif;">非罕見疾病藥物依藥事法規定製造或輸入我國確有困難，且經罕見疾病及藥物審議委員會認定有助於特定疾病之醫療者，準用前項之規定。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 3&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">依前條規定專案申請罕見疾病藥物，應填具申請書，並檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一、由罕見疾病病患或家屬提出申請者：病患身分證明文件影本、醫療機構出具之診斷證明書或處方、該藥物出產國仿單，或有關之安全或療效資料。</span> </p><p><span style="font-family: 新細明體,serif;">二、由政府機關、醫療機構及相關基金會、學會、協會提出申請者：病患同意書、醫療機構提出之治療計畫書或出具之診斷證明書、該藥物出產國仿單，或有關之安全或療效資料。</span> </p><p><span style="font-family: 新細明體,serif;">三、由中央主管機關委託或指定之機關、團體提出申請者：病患同意書、醫療機構提出之治療計畫書或出具之診斷證明書、該藥物出產國仿單，或有關之安全或療效資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 4&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">中央主管機關應於收受專案申請書件三十日內，完成審查作業，並將審查結果以書面通知申請人。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 5&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">專案申請藥物，每次以足供一病患二年之用量為限，並得視實際需要分批辦理。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;">&nbsp;&nbsp;&nbsp; 6&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">條</span><span style="font-family: calibri;">&nbsp; </span><span style="font-family: 新細明體,serif;">本辦法自中華民國八十九年八月九日施行。</span> </p> 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6066&type=0
1420503 罕見疾病類,罕見疾病藥物,罕見疾病藥物認定申請要點 行政解釋 罕見疾病藥物認定申請要點 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4504&type=0
1420504 臨床試驗類,藥動學試驗基準,肝功能不全病患的藥動學試驗基準 行政解釋 肝功能不全病患的藥動學試驗基準 <div style="layout-grid: 18pt none;" class="WordSection1"><p style="text-align: center; line-height: 12pt;">&nbsp;</p><p style="text-align: center; line-height: 12pt;">&nbsp;</p><p style="text-align: center; line-height: 12pt;">&nbsp;</p><p style="text-align: center; line-height: 12pt;">&nbsp;</p><p style="text-align: center; line-height: 12pt;">&nbsp;</p><p style="text-align: center;"><span style="font-family: 新細明體,serif; color: black; font-size: 20pt;">肝功能不全病患的藥動學試驗基準</span> </p><p style="text-align: center;"><span style="font-family: 新細明體,serif; color: black; font-size: 20pt;">－臨床試驗設計、數據分析以及對劑量調整與標示的影響</span> </p><p style="text-align: center; line-height: 12pt;">&nbsp;</p><h1 style="text-align: center;"><span style="color: black; font-size: 16pt; text-decoration: underline; text-underline: none;">GUIDANCE FOR PHARMACOKINETICS IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION: STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING</span></h1><p style="text-align: center;">&nbsp;</p><p style="text-align: center;"><span style="font-family: 新細明體,serif; font-size: 16pt;">行</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">政</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">院</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">衛</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">生</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">署</span> </p><p style="text-align: center;"><span style="font-family: 新細明體,serif; font-size: 16pt;">中華民國九十年七月</span> </p></div><span style="font-family: times new roman,serif; font-size: 16pt;"><br style="page-break-before: always;" clear="all" /></span><div style="layout-grid: 18pt none;" class="WordSection2"><p style="text-align: center;"><span style="font-family: 新細明體,serif; color: black; font-size: 16pt;">目錄</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第一章、前言</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第二章、背景</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第三章、決定是否須於肝功能不全病患執行臨床試驗</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第四章、臨床試驗設計</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第五章、數據分析</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第六章、標示</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">參考文獻</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">附錄：肝功能的評估</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 10pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 12pt;"><b><span style="font-family: 新細明體,serif; color: black;">第一章、前言</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 11.9pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 11.9pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">本基準的目的在協助試驗委託者執行評估肝功能不全對藥品藥動學</span><span style="color: black; font-size: 11pt;">(pharmacokinetics)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">性質之影響的試驗</span><span style="font-family: 新細明體,serif; font-size: 11pt;">，並且依據試驗結果作適當的劑量調整與標示，<span style="color: black;">必要時也將評估肝功能不全對於藥品藥效學（</span></span><span style="color: black; font-size: 11pt;">pharmacodynamics</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）性質之影響。此外，針對此一特殊群體所做的試驗分析結果亦可作為銜接性試驗的考量因素之一。本基準的內容包含：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">何時應執行藥品在肝功能不全病患的藥動學試驗</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">設計與執行藥品在肝功能不全病患的藥動學試驗</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">臨床試驗群體之特性</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">臨床試驗結果的分析、解釋及報告，以及如何在標示</span><span style="color: black; font-size: 11pt;">(labeling)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">中描述這些結果</span> </p><p style="margin: 0cm 1.4pt 0pt 12pt;"><span style="font-family: 新細明體,serif; font-size: 11pt;">本基準並不提供如何評估藥品在治療肝臟疾病的安全性及有效性，也不提供如何評估藥品是否會引起肝毒性。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">第二章、背景</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝臟與許多藥品的清除（</span><span style="color: black; font-size: 11pt;">clearance</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）有關，它可經由不同的代謝途徑或經由膽汁排泄的途徑排除原藥品或其代謝物。肝功能不全所引起藥品排泄或代謝速率的改變，會造成藥品蓄積或阻礙藥品形成活性代謝物。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　許多文獻顯示肝病會改變藥品的藥動學及藥效學性質。這些報告中的試驗對象是患有常見肝病的病患。我國常見之肝病包括慢性</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型或</span><span style="color: black; font-size: 11pt;">C</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型肝炎或肝硬化、脂肪肝、急性</span><span style="color: black; font-size: 11pt;">A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型或</span><span style="color: black; font-size: 11pt;">D</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型肝炎、酒精性肝病（</span><span style="color: black; font-size: 11pt;">alcoholic liver disease</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）以及原發型膽汁性肝硬化（</span><span style="color: black; font-size: 11pt;">primary biliary cirrhosis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）。由於國情環境的差異，美國</span><span style="color: black; font-size: 11pt;">FDA</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">所列舉的常見肝病中的急性</span><span style="color: black; font-size: 11pt;">E</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型肝炎、原發型硬化性膽道炎（</span><span style="color: black; font-size: 11pt;">primary sclerosing cholangitis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）與</span><span style="font-family: symbol; color: black; font-size: 11pt;">a</span><sub><span style="color: black; font-size: 11pt;">1</span></sub><span style="color: black; font-size: 11pt;">-</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">抗胰蛋白酵素缺乏症（</span><span style="font-family: symbol; color: black; font-size: 11pt;">a</span><sub><span style="color: black; font-size: 11pt;">1</span></sub><span style="color: black; font-size: 11pt;">-antitrypsin deficiency</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）在國人則相當罕見，而急性</span><span style="color: black; font-size: 11pt;">D</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型肝炎則是國人常見的一種肝病。肝病也可能會影響腎功能，以至於即使肝臟並非某些藥品的主要清除途徑，仍然會引起藥品及其代謝物的蓄積。肝病也會造成藥品藥效（</span><span style="color: black; font-size: 11pt;">PD effects</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）的改變，例如某些藥品會增加肝衰竭病患之肝腦病變。至於其他疾病對於肝功能的特定影響，尤其在評估對於藥品藥動及藥效的影響上，通常只被簡略的描述，而且其結論之差異性頗大。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　對於主要經由腎臟排除的藥品，測量肌氨酸酐</span><span style="color: black; font-size: 11pt;">(creatinine)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或其清除率則常被用來調整此類藥品的劑量。同樣的，膽紅素（</span><span style="color: black; font-size: 11pt;">bilirubin</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、白蛋白（</span><span style="color: black; font-size: 11pt;">albumin</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、前凝血酵素時間（</span><span style="color: black; font-size: 11pt;">prothrombin time</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、</span><span style="color: black; font-size: 11pt;">antipyrine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">indocyanine green</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">ICG</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、</span><span style="color: black; font-size: 11pt;">monoethylglycinexylidide</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">MEGX</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）及半乳糖（</span><span style="color: black; font-size: 11pt;">galactose</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）等連續性變數也曾被用來測量肝功能。此外，類別性的臨床變數也曾被用來評估肝功能。這些臨床變數包括腹水（</span><span style="color: black; font-size: 11pt;">ascites</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、腦病變（</span><span style="color: black; font-size: 11pt;">encephalopathy</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、營養狀況、週邊水腫</span><span style="color: black; font-size: 11pt;">(peripheral edema)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、病理學上肝纖維化的程度，或是變數的組合，如</span><span style="color: black; font-size: 11pt;">Child-Pugh </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法用於對酒精性肝硬化</span><span style="color: black; font-size: 11pt;">(alcoholic cirrhosis) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">及門脈高血壓</span><span style="color: black; font-size: 11pt;">(portal hypertension)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">Mayo risk scores</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">用於對原發型膽汁性肝硬化（</span><span style="color: black; font-size: 11pt;">primary biliary cirrhosis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）及原發型硬化性膽管炎</span><span style="color: black; font-size: 11pt;">(primary sclerosing cholangitis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，以及</span><span style="color: black; font-size: 11pt;">Maddrey</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">－</span><span style="color: black; font-size: 11pt;">Carithers discriminant function</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">用於對急性酒精性肝炎（</span><span style="color: black; font-size: 11pt;">acute alcoholic hepatitis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）等（詳見附錄：肝功能評估方法）。然而，即使有上述的努力，目前仍無任何一種方法，已在臨床上被廣泛用來預測肝功能不全對於藥品藥動學及藥效學性質的影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">雖然臨床上並無有效的肝功能測量方法被廣泛用來預測藥品的藥動學及藥效學性質，藥品於研發階段在肝功能不全病患上所執行的臨床試驗，仍足以提供有用的資訊來決定此藥品在肝功能不全病患的起始劑量。但使用這些資訊必得配合仔細觀察及劑量逐步調整（</span><span style="color: black; font-size: 11pt;">dose titration</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）以獲致個別病人之最佳使用劑量。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">第三章、決定是否須於肝功能不全病患執行臨床試驗</span> </b></p><h2 style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一、何時可能須於肝功能不全病患執行臨床試驗</span> </h2><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當藥品或其活性代謝物顯著經由肝臟代謝或排泄，本基準建議於肝功能不全病患執行藥動學試驗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當藥品或其活性代謝物具有狹窄治療範圍（</span><span style="color: black; font-size: 11pt;">narrow therapeutic range</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）或可能用於腎衰竭病患時，肝臟代謝之途徑變得較為重要，即使其原來未顯著（</span><span style="color: black; font-size: 11pt;">&lt;20</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">﹪）經肝臟代謝或排除，本基準也建議於肝功能不全病患執行臨床試驗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當藥品的代謝不明，且缺乏其它資料顯示肝排除途徑之比例較低時<b>，</b>應考慮該藥可能會被肝臟顯著代謝。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">四</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當肝病種類與藥品原開發國不同時，應考慮該藥品在肝臟之代謝可能會因而受到影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><h2 style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二、何時可能不須於肝功能不全病患執行臨床試驗</span> </h2><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">對於某些藥品，肝功能不全不太可能明顯改變其藥動學性質，而須調整劑量；在這些況下，此類臨床試驗可能有益於預測藥品性質但並非必要。下述藥品的性質可能有助於判斷：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品完全經由腎臟排除且與肝臟無關。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品只有少部份（＜</span><span style="color: black; font-size: 11pt;">20</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">﹪）被肝臟代謝，且其治療範圍很廣，因此肝功能不全並不會產生毒性或增加該藥與其他藥品間的交互作用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">氣態或揮發性藥品，且該藥品及其活性代謝物主要經由肺臟排除。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">四</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">對於單次使用的藥品，除非有臨床上的考慮，也許不須以肝功能不全病患進行臨床試驗。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">第四章、臨床試驗設計</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">試驗設計的重點如下</span><span style="color: black; font-size: 11pt;">:</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一、簡式臨床試驗設計</span><span style="color: black; font-size: 11pt;">(Reduced Study Design)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二、基本完整的臨床試驗設計</span><span style="color: black; font-size: 11pt;">(Basic Full Study Design)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三、群體藥動處理方式</span><span style="color: black; font-size: 11pt;">(Population PK Approach)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一、簡式臨床試驗設計</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）、受試者</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">FDA</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">在調查</span><span style="color: black; font-size: 11pt;">1995</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">1998</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">年間為了新藥申請</span><span style="color: black; font-size: 11pt;"> (New Drug Applications, NDAs) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">所執行的</span><span style="color: black; font-size: 11pt;">57</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個針對肝功能不全病患進行的藥動學研究時發現，其中的</span><span style="color: black; font-size: 11pt;">55% </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">使用</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法來評估肝功能。在這</span><span style="color: black; font-size: 11pt;">57</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗中有</span><span style="color: black; font-size: 11pt;">19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗包括藥品在各種受試者上的口服清除率；這些受試者包括具有正常肝功能及肝功能不全的病患（依</span><span style="color: black; font-size: 11pt;">Child-Pugh </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類為輕度、中度及重度）。而這</span><span style="color: black; font-size: 11pt;">19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗中的</span><span style="color: black; font-size: 11pt;">17</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗結果顯示口服藥品清除率與肝功能不全的嚴重程度呈負相關</span><span style="color: black; font-size: 11pt;"> (</span><span style="font-size: 11pt;">r<sup>2</sup> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">介於</span><span style="color: black; font-size: 11pt;">0.5 </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">和</span><span style="color: black; font-size: 11pt;">1.0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之間</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。同時，這</span><span style="color: black; font-size: 11pt;">19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗中的</span><span style="color: black; font-size: 11pt;">16</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗結果顯示在</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類為中度肝功能不全的病患有肝臟代謝機能不全。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">就像使用血清肌氨酸酐的濃度或肌氨酸酐清除率來評估腎功能不全的程度一樣，我們建議用</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法來評估肝功能不全的程度。這就像用血清肌氨酸酐的濃度或肌氨酸酐清除率來評估腎功能不全的程度一樣。但是單用此分類法或任何一種分類法仍嫌不足，為了可以更有效地預測肝功能不全對藥品藥動學與藥效學性質之影響，所以建議在使用</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法的同時，併用其他可能適用於評估肝功能的方法，例如：我國研究者於</span><span style="color: black; font-size: 11pt;">1992</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">年所發表的半乳糖單點法（</span><span style="color: black; font-size: 11pt;">Galactose Single Point, GSP</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）已為</span><span style="color: black; font-size: 11pt;">FDA</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">基準中所推薦，且已在國人常見肝病驗證過的一種用來評估殘餘之肝功能（</span><span style="color: black; font-size: 11pt;">residual liver function</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）的極為簡便可行的方法（詳見附錄﹔肝功能的評估）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">基於上述的數據，簡式臨床試驗設計如能包括肝功能正常的受試者與</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類為中度肝功能不全的病患，一般而言已經足夠。在這種情形下，在中度肝功能不全的病患的發現將可應用於輕度肝功能不全的病患，而重度肝功能不全的病患則通常列為禁忌</span><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">詳見</span><span style="color: black; font-size: 11pt;"> &ldquo;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">標示</span><span style="color: black; font-size: 11pt;">&rdquo; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">部份</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。然而對於治療範圍狹窄的藥品則應考慮進行基本完整的試驗設計，並配合臨床試驗的結果來修訂標示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp; </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">本基準的主要目的是希望能決定是否一個藥品或其代謝物的藥動學及</span><span style="color: black; font-size: 11pt;">/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或藥效學被改變的程度，已達到需要調整該藥在肝功能不全病患的使用劑量。基於這個理由，控制組的受試者應是肝功能正常的病患而不一定需要年輕健康的自願者。而且，控制組的年齡、體重及性別應儘可能的與肝功能不全組類似。根據藥品的性質，其他可能顯著影響藥品藥動之因素</span><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例如</span><span style="color: black; font-size: 11pt;">: </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">飲食、抽煙、酒精攝取量、併用藥品、種族</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">也應該考慮進去。對於已知具有遺傳多形性</span><span style="color: black; font-size: 11pt;">(genetic polymorphism</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，例如</span><span style="color: black; font-size: 11pt;">: CYP2D6</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">CYP2C19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">酵素參與代謝的藥品</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，試驗委託者於分析結果時應考慮到受試者本身的代謝狀態。除了在參與臨床試驗前所作的標準檢驗項目外，試驗委託者可考慮利用標誌物如半乳糖、</span><span style="color: black; font-size: 11pt;">ICG</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">antipyrine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">MEGX</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">來評估肝血流</span><span style="color: black; font-size: 11pt;">(hepatic blood flow)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或內在清除率</span><span style="color: black; font-size: 11pt;">(intrinsic clearance)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（詳見附錄：肝功能的評估）。此外，應該招募足夠數目的受試者，俾能收集到每組至少</span><span style="color: black; font-size: 11pt;">8</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">位可評估受試者的數據。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）、藥品的給予</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一個研究肝功能不全對藥品處置</span><span style="color: black; font-size: 11pt;">(drug disposition)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">影響的臨床試驗，可設計為評估在給予單一或多次劑量藥品後，該藥品及其活性代謝物的藥動學性質。對於給予多次劑量試驗，應於給藥的第一天以及達到穩定狀態</span><span style="color: black; font-size: 11pt;">(steady state)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">時評估其藥動學性質。如果曾有數據顯示由給予單一劑量的藥動學性質，可正確的推算出給予多次劑量時藥品及其活性代謝物的藥動性質，則只須執行單一劑量的臨床試驗。若於受試者所使用的藥品劑量範圍內，該藥品及其活性代謝物呈線性且不受時間影響的藥動學性質時則屬此類。當藥品或其活性代謝物呈非線性或會受時間影響的藥動學性質時，則給予多次劑量的臨床試驗則是必須的。雖然，臨床試驗計畫中所使用的臨床劑量通常是標示上所敘述的劑量，如對試驗受試者因肝功能不全而藥品血中濃度增加所致的毒性有所顧慮時，則可降低給予劑量。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（三）、樣品採集與分析</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">血液樣品的採樣期程應足以決定藥品及其活性代謝物之末相半衰期</span><span style="color: black; font-size: 11pt;"> (terminal half-life)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，而且這個期程設計應可同時適用於控制組以及病患。對於被肝臟高度抽取的藥品</span><span style="color: black; font-size: 11pt;">( extraction ratio &gt; 0.7)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以及與血漿蛋白質高度結合的藥品</span><span style="color: black; font-size: 11pt;"> (fraction unbound &lt; 20%)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，至少在該藥血漿濃度最低</span><span style="color: black; font-size: 11pt;">(trough)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">與最高</span><span style="color: black; font-size: 11pt;">(maximal)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">時，測量其未結合狀態的比例。清除率及體積參數</span><span style="color: black; font-size: 11pt;">(volume parameters)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">應以藥品於血漿及</span><span style="color: black; font-size: 11pt;">/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或血清中濃度</span><span style="color: black; font-size: 11pt;">(total concentration)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">及未結合狀態濃度來表示。分析方法應有足夠的靈敏度與特異性俾能檢測出藥品及其活性代謝物。對於具有立體化學特性的藥品，藥品代謝的立體化學選擇性以及鏡像異構物</span><span style="color: black; font-size: 11pt;">(enantiomers)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">與蛋白質結合的情形也應列入考慮。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二、基本完整的臨床試驗設計</span></b><b><span style="color: black; font-size: 11pt;"> (Basic Full Study Design) </span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">為了在標示中註明對各種肝功能不全病患的建議劑量，基本完整的臨床試驗設計應包括控制組以及依據</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法分類為輕度、中度與重度的病患，對於治療範圍狹窄之藥品宜配合附錄中的方法來定量肝功能，並依結果修正劑量與標示。此試驗應該招募足夠數目的受試者，俾能每組中至少有</span><span style="color: black; font-size: 11pt;">6</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">位可評估受試者的數據以供評估。此外，於本基準第四章第一節中考量的種種因素，也應在此臨床試驗設計列入考慮。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三、群體藥動處理方式</span></b><b><span style="color: black; font-size: 11pt;">(Population PK Approach)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果在第二階段或第三階段臨床試驗中未排除肝功能不全的病患，而且有足夠的藥動學資料來描述這些病患肝功能不全的特性，則從第二階段或第三階段臨床試驗中群體藥動學的篩選，可能有助於評估不同肝功能的變數</span><span style="color: black; font-size: 11pt;">(covariates)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">對藥動學的影響。如果決定使用群體藥動學處理方式，則必須評估第二階段或第三階段臨床試驗中病患的腦病變</span><span style="color: black; font-size: 11pt;">(encephalopathy)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、腹水</span><span style="color: black; font-size: 11pt;">(ascites)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、血清膽紅素</span><span style="color: black; font-size: 11pt;"> (serum bilirubin)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、血清白蛋白</span><span style="color: black; font-size: 11pt;">(serum albumin)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、前凝血酵素時間</span><span style="color: black; font-size: 11pt;">(prothrombin time) (</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以上是</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法的檢測項目</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、或是其他類似組合的肝功能檢測。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一個群體藥動學研究應該包括</span><span style="color: black; font-size: 11pt;">:</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）預先計畫好的分析方法</span><span style="color: black; font-size: 11pt;">(pre-planned analysis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">來分析肝功能不全的影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）對於肝病嚴重程度的評估。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（三）足夠數目的病患以及足以代表各種不同肝功能不全的病患，以偵測到須要調整劑量的藥動變化。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（四）必要時，檢測未結合狀態的藥品濃度。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（五）檢測藥品及其活性代謝物。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果試驗委託者打算利用上述測試的結果來支持標示中註明肝功能不全病患不須調整劑量，以上的臨床試驗計畫特性將會非常重要。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">四、藥效學評估</span></b><b><span style="color: black; font-size: 11pt;"> (Pharmcodynamic Assessments)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">對於一個研究計畫是在評估肝功能改變所造成的影響時，尤其是在沒有濃度反應相關性的數據</span><span style="color: black; font-size: 11pt;"> (concentration-response data)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或是擔心肝功能改變也可能造成藥效反應的改變時，藥效學評估試驗是可能非常有用的。藥效學評估指標</span><span style="color: black; font-size: 11pt;"> (pharmacodynamic endpoints) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的選擇應取決於藥品及其活性代謝物的藥理特性。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">第五章、數據分析</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">數據分析的主要目的在於評估肝功能不全對於藥品及其活性代謝物藥動學性質的影響。如果可能的話，建立某一特定或某群肝功能評估方法（如</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或附錄中其他肝功能之定量測定方法）和相關藥動學測量及</span><span style="color: black; font-size: 11pt;">/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或參數的相關性，進而從這些資料建立肝功能不全病患的建議劑量。</span> </p><p style="line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一、參數預測</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分析血中或尿中藥品濃度以預測藥品及其活性代謝物的藥動學參數，這些參數包括曲線下面積（</span><span style="color: black; font-size: 11pt;">AUC</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），最高濃度（</span><span style="color: black; font-size: 11pt;">C<sub>max</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），擬似清除率（</span><span style="color: black; font-size: 11pt;">apparent clearance CL/F</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），腎及非腎清除率（</span><span style="color: black; font-size: 11pt;">CL<sub>R</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">及</span><span style="color: black; font-size: 11pt;">CL<sub>NR</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），擬似分佈體積（</span><span style="color: black; font-size: 11pt;">V<sub>dz</sub> or V<sub>dss</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）及半衰期（</span><span style="color: black; font-size: 11pt;">t<sub>1/2</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）。必要時，這些參數可以藥品的非結合態表示（如</span> <span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">：</span><span style="color: black; font-size: 11pt;">CL<sub>u</sub>/F=Dose/AUC<sub>u</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">；</span><span style="color: black; font-size: 11pt;">u</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表未結合態藥品）。非室性模式</span><span style="color: black; font-size: 11pt;">(Noncompartment) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或室性模式</span><span style="color: black; font-size: 11pt;">(compartment) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的方式都可用來評估這些參數。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二、肝功能測量與藥動學之相關性</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">過去經驗顯示，臨床上各種肝功能的測量，並無法像腎功能測量般成功的預測藥品藥動學性質的改變<b>。</b>用線性及非線性的模式可將肝功能異常與特定的藥動學參數建立相關性，肝功能異常的測量例如測量肝血流量、血清白蛋白濃度、前凝血酵素時間</span><span style="color: black; font-size: 11pt;">(prothrombin time)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法及其它定量方法（如半乳糖單點法）等來判定，藥動學參數則包括總體清除率、口服清除率、擬似分佈體積、未結合態藥品的清除率或劑量標準化後的未結合態藥品曲線下面積等。使用迴歸方法分析肝功能不全及藥動學參數等連續性變數是適當的，但要了解有些相關性仍有賴於類別變數（如</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或附錄中其他肝功能之定量測定方法）。如果採模式化分析，結果應包含所選擇模式參數的預測值及測量精確度（如標準誤差或信賴區間）。誤差值的估計亦有助於模式適合性的評估。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三、建議劑量的建立</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全病患臨床試驗的主要目的在於提供有關病患併有肝病時，藥品之起始劑量、給與間隔是否應做改變的建議，並且了解對此群體仍須小心調整劑量。依據臨床試驗的結果，試驗受試者或可於標示中宣稱肝功能不全並不會影響藥品的藥動學性質。基於這些臨床試驗的本質是屬於比較性質的，因此評估這類結果，以信賴區間（</span><span style="color: black; font-size: 11pt;">Confident interval </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">表示方法將優於以顯著檢定方法（</span><span style="color: black; font-size: 11pt;">Significance test</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）表示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">建議劑量的建立一般可基於下列考量：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）如果肝功能不全對藥動學有明顯影響（例如增加</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">倍以上），必要的劑量調整應註明於標示中。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）如果試驗受試者欲宣稱肝功能不全並不會影響藥品的藥動學性質，則必須具備下列條件之一：（</span><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）根據試驗用藥已有的資料（如劑量及／或濃度與療效反應試驗），在試驗前描述</span><span style="color: black; font-size: 11pt;">&rdquo;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">無影響界限</span><span style="color: black; font-size: 11pt;">&rdquo;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">no effect boundaries</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）；（</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）在缺乏其他足以認定不同相等區間（</span><span style="color: black; font-size: 11pt;">equivalence interval</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）之資訊時，可以標準的</span><span style="color: black; font-size: 11pt;">90%</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">信賴區間</span><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">即</span><span style="color: black; font-size: 11pt;">AUC</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">須落於</span><span style="color: black; font-size: 11pt;">80-125%</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的範圍內，而且</span><span style="color: black; font-size: 11pt;">Cmax</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">須落於</span><span style="color: black; font-size: 11pt;">70-143%</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的範圍內</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">來適用於試驗用藥。因肝功能不全病患臨床試驗通常受試者人數較少，因此並不易確定於某一信賴區間範圍內，藥動學參數仍維持在某一</span><span style="color: black; font-size: 11pt;">&rdquo;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">無影響界限</span><span style="color: black; font-size: 11pt;">&rdquo;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">內。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（三）因為主要問題為處方用法、用量，群體相等性之標準（非個體相等性標準）對適用於控制組中藥動學測量或參數的變異性，可能有所幫助。此標準並不須重覆試驗設計。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">第六章、標示</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品標示應反應肝功能不全對藥品藥動學與藥效學的影響。雖然藥品的性質及肝功能不全對藥品的影響使得標示不易，但對使用</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法，並配合附錄中其他定量測定方法評估肝功能之後，列為中度肝功能不全病患，如試驗用藥品之清除率有顯著降低時，應減低其藥品劑量。一般而言，依</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法歸類為輕度肝功能不全的病患也應作類似的劑量調整。依據藥品的使用及治療指標</span><span style="color: black; font-size: 11pt;">(therapeutic index)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的寬窄，對</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法歸類為重度肝功能不全病患，可能要列為「禁忌」或特別小心使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">反之，如果臨床試驗結果顯示中度肝功能不全病患的藥品排除率並無顯著改變，則藥品可用於輕度及中度肝功能不全病患而無需調整其劑量。依據藥品的使用與治療指標的寬窄，通常對重度肝功能不全病患應標示小心使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　　</span> </p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果依據第三章第二節中所列的理由而不須執行肝功能不全病患之臨床試驗，則標示中應標明肝功能不全對藥品的影響未曾測試且可能不須要調整劑量。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一、臨床藥理學</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）藥動學</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥動學應包括藥品的：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝臟排除的機轉（酵素途徑，尿甘酸化結合度</span><span style="color: black; font-size: 11pt;">(glucuronidation)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">及膽汁排除等）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品被肝臟排除的比例。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代謝物在肝功能不全病患之藥動學（如果適用）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm -7.7pt 0pt 72pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對藥品及其代謝物之蛋白質結合度的影響（如果適用）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;">&nbsp;&nbsp; </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對消旋異構物中鏡像異構物的立體選擇處置（如果有證據顯示不同立體異構物中有不同活性或毒性）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）特殊群體（</span><span style="color: black; font-size: 11pt;">Special Populations</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">應簡短的重述藥動學之變化及說明肝功能不全病患藥效性質之改變及劑量之調整。這些訊息應基於依本基準所建議各項試驗或可接受之替代試驗所得的結果。必要之資訊亦應標示於警語（</span><span style="color: black; font-size: 11pt;">WARNINGS</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、注意事項（</span><span style="color: black; font-size: 11pt;">PRECAUTIONS</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）、禁忌（</span><span style="color: black; font-size: 11pt;">CONTRAINDICATIONS</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）及用法用量（</span><span style="color: black; font-size: 11pt;">DOSAGE AND ADMINISTRATION</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）等。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例一：</span><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">最簡單的情形是在肝功能不全病患執行臨床試驗，結果顯示藥品的藥動學及藥效學甚少或並未改變，標示內容建議如下：</span> </p><p style="line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">在一項比較</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">8</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個中度肝功能不全病患（依</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">Child-Pugh</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法評估，並配合附錄中其他肝功能之定量測定方法所得數據評估肝功能）與</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">8</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個正常肝功能受試者的臨床試驗中，給予單一劑量及</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或多次劑量，（ˍ藥品名稱）於肝功能不全病患，並未發現藥動／藥效學性質改變，因此於輕度及中度肝功能不全病患並不需調整用法用量。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例二：</span><span style="color: black; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當肝功能不全會影響藥品的藥動學及藥效學性質時，依據已知的藥品性質（例如消旋異構物中具不同活性的立體異構物，包括活性或毒性的代謝物）以及依據本基準所執行的臨床試驗所得到的結果，可適度修改標示如下：</span> </p><p style="line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">比較（ˍ藥品名稱）在肝功能不全病患及正常肝功能受試者的藥動性質，（ˍ藥品名稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代謝物的全體清除率在中度肝功能不全病患（經</span></i><i><span style="color: black; font-size: 11pt;">Child-Pugh</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法評估）降低了ˍ（％）；在中度肝功能不全病患，（ˍ藥品名稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代謝物的半衰期延長了</span></i><i><span style="color: black; font-size: 11pt;">__(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">時間</span></i><i><span style="color: black; font-size: 11pt;">)</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。（ˍ藥品名稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代謝物的蛋白質結合率在肝功能不全病患上有（或無）改變。在長期給藥後，（ˍ藥品名稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代謝物在肝功能不全病患會蓄積到</span></i><i><span style="color: black; font-size: 11pt;">___</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之程度。在輕度及中度肝功能不全病患，（ˍ藥品名稱）的劑量應降低。在重度肝功能不全病患，（ˍ藥品名稱）的使用應特別注意或禁止使用</span></i><i><span style="color: black; font-size: 11pt;">(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">請參照用法用量</span></i><i><span style="color: black; font-size: 11pt;">)</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例三：</span><span style="color: black; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當無肝功能不全病患的資料來作為標示的依據時，標示的內容如下：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品不經過肝臟排除</span><span style="color: black; font-size: 11pt;">(elimination)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對（ˍ藥品名稱）藥動性質的影響未經評估。因為大於</span></i><i><span style="color: black; font-size: 11pt;">90%</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的給藥劑量以原型經由尿液排出，肝功能不全應不至顯著影響（ˍ藥品名稱）之排除。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i></i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">少部份經由肝臟排除（</span><span style="color: black; font-size: 11pt;">Hepatic elimination &lt;20</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">﹪）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(1)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標較廣的藥品</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對（ˍ藥品名稱）藥動性質的影響未經評估。因為大於</span></i><i><span style="color: black; font-size: 11pt;">80%</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的給藥劑量以原型經由尿液排出，肝功能不全應不至顯著影響（ˍ藥品名稱）血中濃度而影響其安全性。如果病患也有腎衰竭的情形，肝臟排除藥品的重要性會增加。相較於肝功能正常之受試者，可能需要降低肝功能不全病患之起始及維持劑量或者延長給藥間隔</span></i><i><span style="color: black; font-size: 11pt;">(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">請參照注意事項</span></i><i><span style="color: black; font-size: 11pt;">)</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i></i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(2)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標狹窄的藥品</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對（ˍ藥品名稱）的藥動學性質影響未經評估，因為此藥的一般治療劑量與引起藥品不良反應之劑量相近。而且從體內（</span></i><i><span style="color: black; font-size: 11pt;">in vivo</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）或體外（</span></i><i><span style="color: black; font-size: 11pt;">in vitro</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）的證據中顯示，（ˍ藥品名稱）會經由肝臟排除，因此肝功能不全可能會增加藥品不良反應的發生機率。相較於肝功能正常之受試者，可能需要降低（ˍ藥品名稱）在肝功能不全病患的起始及維持劑量或是延長其給藥間隔。如果病患有腎衰竭的現象，肝臟排除藥品的重要性會因而增加，所以此類病患應避免使用（ˍ藥品名稱），如須使用（ˍ藥品名稱）必須特別小心監視。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　　</span><i> </i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">主要經由肝臟排除</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(1)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標較廣之藥品</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對於（ˍ藥品名稱）藥動學性質的影響未經評估。因為有體內及體外的證據顯示（ˍ藥品名稱）主要經由肝臟代謝，因此預期肝功能不全可能會顯著改變（ˍ藥品名稱）的藥動學性質。</span></i><i> </i></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">相較於肝功能正常之受試者，在肝功能不全病患使用此藥應特別小心，而且可能必須降低起始及維持劑量或是延長其給藥間隔。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　　　　</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(2)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標狹窄之藥品</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對於（ˍ藥品名稱）的藥動學性質的影響未經評估。因為小於</span></i><i><span style="color: black; font-size: 11pt;">20%</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的給藥劑量會以原型經由尿液排出，而且有體外及體內的證據顯示該藥品主要經由肝臟代謝。肝功能不全可能會顯著影響（ˍ藥品名稱）的藥動學性質。（ˍ藥品名稱）應不能使用於肝功能不全病患，如必須要用，應特別小心。</span></i><i><span style="color: black; font-size: 11pt;">(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">請參照禁忌</span></i><i><span style="color: black; font-size: 11pt;">)</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i></i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝臟排除尚不明確</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">在這種情形下，此藥品視為會顯著經由肝臟代謝而適用上述標示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二、注意事項及警語</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果肝功能不全病患會引起藥動學及藥效學臨床上的重要改變，則這些訊息應包括在「注意事項」並參考「用法用量」。如果已知藥品有狹窄的治療指標，則應在「警語」或「禁忌」中註明。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三、用法用量</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">應於適當處註明下列文字，例如：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">肝功能不全對（ˍ藥品名稱）的藥動學或藥效學性質的影響並不顯著，因此不須調整劑量。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">惟因肝功能不全而須調整劑量時，仍應列入適當的資訊。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">此外，複方製劑也須特別考量。如果有足夠的證據顯示肝功能不全病患對於複方中個別成分的藥動學性質有類似的影響，則應依肝功能不全之程度適度調整劑量。否則，應依以下的文字標示：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">因為在固定比例的複方製劑中，各別成份無法訂定，肝功能不全會降低藥品清除率，而對複方中</span></i><i><span style="color: black; font-size: 11pt;">A</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">成分的影響遠大於對複方中</span></i><i><span style="color: black; font-size: 11pt;">B </span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">成分的影響，所以肝功能不全病患應避免使用此複方（必要時，詳見「注意事項」與「警語」）。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果複方中各成份的比例不同，且有各成份比例不同的複方製劑可供選擇，則儘可能要求醫師使用較少經由肝臟代謝成份的產品。</span> </p></div><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">參考文獻</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">1.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(1997). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品臨床試驗申請須知（台北）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">2.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(1999). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品查驗登記審查準則（台北）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">3.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(2000). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品非臨床試驗安全性規範（台北）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">4.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(2000). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">臨床試驗基準（台北）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">5.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(2000). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥品非臨床試驗優良操作規範（台北）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">6.Draft Guidance for Inducstry, Pharmacokinetics in Patients with Impaired Hepatic Function:Study Design, Data Analysis, and Impact on Dosing and Labeling. FDA, USA, 1999.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">7.Hu O.Y-P., Tang, H.S., and C.L. Chang, 1994, "The Influence of Chronic Lobular Hepatitis on Pharmacokinetics of Cefoperazone</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">－</span><span style="color: black; font-size: 11pt;">A Novel Galactose Single-point Method as a Measure of Residual Liver Function." <i>Biopharm. Drug Dispos, 15(7): 563-576</i>.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">8.Hu O.Y-P., Tang, H.S., and C.L. Chang, 1995, "Novel Galactose Single-point Method as a Measure of Residual Liver Function:Example of Cefoperazone Kinetics in Patients with Liver Cirrhosis." <i>J. Clin. Pharmacol. 35(3): 250-258</i>.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">9.Shargel L. and A. Yu. 1999. <i>Applied Biopharmaceutics &amp; Pharmacokinetics. 4<sup>th</sup> ed., p.566,</i> Prentice-Hall International, Inc.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">10.Tang, H. -S., O.Y.-P. Hu., 1992, "Assessment of Liver Function Using a Novel Galactose Single Point Method," <i>Digestion, 52:222-231</i>.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">附錄：肝功能的評估</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">系統</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 281.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">觀察結果所得點數</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">腦病變程度</span><span style="color: black; font-size: 11pt;">*</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">無</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">腹水</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">無</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">輕度</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">中度</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">血清膽紅素濃度（</span><span style="color: black; font-size: 11pt;">mg/dl</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＜</span><span style="color: black; font-size: 11pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＞</span><span style="color: black; font-size: 11pt;">3</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">血清白蛋白濃度（</span><span style="color: black; font-size: 11pt;">g/dl</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＞</span><span style="color: black; font-size: 11pt;">3.5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2.8</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">3.5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＜</span><span style="color: black; font-size: 11pt;">2.8</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">前凝血酵素時間延長秒數</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＜</span><span style="color: black; font-size: 11pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">6</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＞</span><span style="color: black; font-size: 11pt;">6</span></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">*0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：意識、人格、神經學檢查、腦電圖均正常</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：不安，睡眠不良，易受刺激，躁動、四肢顫抖，無法寫字，腦波出現</span><span style="color: black; font-size: 11pt;">5Hz</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">慢波</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：嗜睡，時間認知差，情感表現不適，運動障礙，運動失調，腦波出現三相慢波</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：倦睡，木僵，對地方認知差，反射增強，僵直，腦波出現慢波</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：無法喚醒的昏迷，人格及行為喪失，去大腦姿勢，腦波出現</span><span style="color: black; font-size: 11pt;">2-3Hz</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">慢波</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">評估結果為</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">5-6</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分：表示低開刀風險，即肝功能受損較輕微；</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">7-9</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分：表示中度開刀風險，即肝功能受損為中度；</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">10-15</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分：表示高開刀風險，即肝功能受損較嚴重（此為酒精性肝硬化病人之外科手術評估）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、半乳糖單點法（</span><span style="color: black; font-size: 11pt;">Galactose Single Point, GSP</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; font-size: 11pt;">本法乃是由唐鴻舜及胡幼圃發表於</span><span style="font-size: 11pt;">1992</span><span style="font-family: 新細明體,serif; font-size: 11pt;">年之</span><span style="font-size: 11pt;">Digestion</span><span style="font-family: 新細明體,serif; font-size: 11pt;">期刊中。</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">為於空腹時，三分鐘快速靜脈輸注</span><span style="font-size: 11pt;">0.5 g/kg</span><span style="font-family: 新細明體,serif; font-size: 11pt;">的半乳糖，經過</span><span style="font-size: 11pt;">60</span><span style="font-family: 新細明體,serif; font-size: 11pt;">分鐘後，測量受試者血中半乳糖的濃度，即為其</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值（單位為</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">）。血中半乳糖濃度，和肝功能異常有靈敏的相關性，且實驗數據顯示</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值與肝功能異常的程度有非常顯著的關係。因此，可經由受試者的</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值來評估其肝臟的剩餘功能，評估方法如下：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-size: 11pt;">(1)<span style="font: 7pt times new roman;">&nbsp; </span></span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值小於</span><span style="font-size: 11pt;">280</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">：肝功能正常或受損輕微。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-size: 11pt;">(2)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值介於</span><span style="font-size: 11pt;">280</span><span style="font-family: 新細明體,serif; font-size: 11pt;">與</span><span style="font-size: 11pt;">480</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">之間：肝功能受損為中度（可能為慢性肝炎患者）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-size: 11pt;">(3)<span style="font: 7pt times new roman;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值大於</span><span style="font-size: 11pt;">480</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">：肝功能受損較嚴重（可能為肝硬化或肝癌患者）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">Maddrey</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">辨識功能</span><span style="color: black; font-size: 11pt;">( Maddrey Discriminant Function, df )</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp; df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＝</span><span style="color: black; font-size: 11pt;">4.6&times;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">前凝血酵素時間（秒）＋血清總膽紅素（</span><span style="color: black; font-size: 11pt;">mg/dl</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值來評估急性酒精性肝炎病人之病情可分下列情形：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span> <span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值小於</span><span style="color: black; font-size: 11pt;">54</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，則該疾病並不嚴重</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值介於</span><span style="color: black; font-size: 11pt;">55</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">到</span><span style="color: black; font-size: 11pt;">92</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之間，則該疾病嚴重</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值大於或等於</span><span style="color: black; font-size: 11pt;">93</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，如不治療則可能致死</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span><span style="color: black; font-size: 11pt;"> Carithers</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">等人曾對</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的計算法作以下修正：前凝血酵素改為比正常凝血時間延長之秒數，並將血清膽紅素值除以</span><span style="color: black; font-size: 11pt;">17.1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以取得</span><span style="color: black; font-size: 11pt;">mmol/L</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">單位，代入上式而計算修正後的</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值，修正後病人的</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值大於或等於</span><span style="color: black; font-size: 11pt;">32</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的病人，則被納入</span><span style="color: black; font-size: 11pt;">methylprednisolone</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療試驗（相當於</span><span style="color: black; font-size: 11pt;">Maddrey df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值約</span><span style="color: black; font-size: 11pt;">106</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">Mayo</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">對原發型膽汁肝硬化</span><span style="color: black; font-size: 11pt;">(Primary Biliary Cirrhosis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之存活模式</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">Mayo</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">存活模式乃基於預測死亡因子的</span><span style="color: black; font-size: 11pt;">Cox</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">正比危害回歸分析（</span><span style="color: black; font-size: 11pt;">Cox proportional hazard regression analyses</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）而得，此複雜的公式採用</span><span style="color: black; font-size: 11pt;">5</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">項最具影響力的變異數計算致死危險性（</span><span style="color: black; font-size: 11pt;">R</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）來預測存活時間</span><span style="color: black; font-size: 11pt;">S</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp; S ( t )</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＝</span><span style="color: black; font-size: 11pt;">{S<sub>o</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">}<sup>exp(R-5.07)</sup></span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><sup><span style="color: black; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span></sup><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">其中</span><span style="color: black; font-size: 11pt;">S</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）即</span><span style="color: black; font-size: 11pt;">t </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">年的存活機率</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span><span style="color: black; font-size: 11pt;"> R</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＝</span><span style="color: black; font-size: 11pt;">0.871 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">2.53 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.039</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">Y</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.859</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">E</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">2.38 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">PT</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表膽紅素，</span><span style="color: black; font-size: 11pt;">mg/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">；</span><span style="color: black; font-size: 11pt;">A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表白蛋白，</span><span style="color: black; font-size: 11pt;">g/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">；</span><span style="color: black; font-size: 11pt;">Y</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表年齡；</span><span style="color: black; font-size: 11pt;">E</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表水腫；</span><span style="color: black; font-size: 11pt;">PT</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表前凝血酵素時間，秒）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;&nbsp; S<sub>o</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）值是由</span><span style="color: black; font-size: 11pt;">418</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">位病人所觀察到的存活結果而得之平均危險分數值（假設</span><span style="color: black; font-size: 11pt;">R=5.07</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）：</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">t years</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">6</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">7</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">S<sub>o</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.970</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.941</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.883</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.883</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.774</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.721</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.651</span></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp; </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">&nbsp;</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">稍後</span><span style="color: black; font-size: 11pt;">Wiesner</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">等人研究</span><span style="color: black; font-size: 11pt;">174</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">位原發硬化性膽道炎</span><span style="color: black; font-size: 11pt;">(primary sclerosing cholangitis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的病人並發展出另一種分析模式。除年齡及血清膽紅素〈最高採用</span><span style="color: black; font-size: 11pt;">10 mg/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">〉外，此回歸分析法還確認血中血紅素濃度（</span><span style="color: black; font-size: 11pt;">Hb</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，</span><span style="color: black; font-size: 11pt;">g/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，在</span><span style="color: black; font-size: 11pt;">12g/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以下），發炎性腸道疾病（</span><span style="color: black; font-size: 11pt;">IBD</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">：</span><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">表示有，</span><span style="color: black; font-size: 11pt;">0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">表示沒有）和組織切片肝纖維化程度（</span><span style="color: black; font-size: 11pt;">S,0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">到</span><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）等重要因子：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">R</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＝</span><span style="color: black; font-size: 11pt;">0.85 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.06</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">Y</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）－</span><span style="color: black; font-size: 11pt;">4.39 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">Hb</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">1.59</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">IBD</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.51S</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">5</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">Monoethylglycinexylidide</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">MEGX</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">此一化合物是</span><span style="color: black; font-size: 11pt;">lidocaine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">經由肝臟</span><span style="color: black; font-size: 11pt;">CYP3A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">酵素系統代謝後的主要代謝物。在連續</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分鐘靜脈輸注</span><span style="color: black; font-size: 11pt;">1mg/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">㎏的</span><span style="color: black; font-size: 11pt;">lidocaine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">後，測量其</span><span style="color: black; font-size: 11pt;">15</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">、</span><span style="color: black; font-size: 11pt;">30</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">及</span><span style="color: black; font-size: 11pt;">60</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分鐘時之濃度，其結果與</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的得分結果有良好的相關性</span><span style="color: black; font-size: 11pt;">(Testa </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">等</span><span style="color: black; font-size: 11pt;">1997)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;">&nbsp;</p> 2013-12-04
1420505 其他類,人體器官組織細胞輸入輸出管理辦法 行政解釋 附表人類器官組織細胞輸入應檢驗項目 <p style="line-height: 15pt; margin: auto 0cm;" class="null"><span style="font-family: 新細明體;"><b><span style="color: black; font-size: 10pt;">附表：人類器官組織細胞輸入應檢驗項目</span></b> </span></p><table style="margin: auto 6.75pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" align="left"> <tbody> <tr style="page-break-inside: avoid; height: 22.25pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 67.1pt; padding-right: 1.4pt; height: 22.25pt; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">用　途</span> </p> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">屬　性</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="text-align: right; layout-grid-mode: char;"><span style="font-size: 10pt;">Test Items </span></p> <p style="layout-grid-mode: char;"><span style="font-size: 10pt;">Type </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 95.4pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">Hepatitis </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 95.3pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">HIV </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">TP </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">TSE </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20.15pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">B </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">C </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">１</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">２</span> </p> </td> </tr> <tr style="height: 27.35pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.1pt; padding-right: 1.4pt; height: 27.35pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">不使用於人體</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">研究、教學、</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">保存用途</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;">&nbsp;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;">&nbsp;</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 20.7pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.1pt; padding-right: 1.4pt; height: 20.7pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">人體醫療用（移植用）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">移植用途之器官、組織、細胞</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span><span style="text-decoration: underline;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;">&nbsp;</span><span style="text-decoration: underline;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 31.5pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">硬腦膜</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-size: 10pt;">Dura mater </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;">&nbsp;</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 8.5pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">其他</span><span style="font-size: 10pt;">other </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;">&nbsp;</span> </p> </td> </tr> <tr style="height: 86.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 452.85pt; padding-right: 1.4pt; height: 86.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">檢驗項目：</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Hepatitis</span><span style="font-family: 新細明體,serif; font-size: 10pt;">：肝炎病毒（</span><span style="font-size: 10pt;">B</span><span style="font-family: 新細明體,serif; font-size: 10pt;">型肝炎病毒，</span><span style="font-size: 10pt;">C</span><span style="font-family: 新細明體,serif; font-size: 10pt;">型肝炎病毒）</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Human immunodeficiency virus</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">HIV</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）：第一型人類免疫缺損病毒（</span><span style="font-size: 10pt;">HIV-I</span><span style="font-family: 新細明體,serif; font-size: 10pt;">），第二型人類免疫缺損病毒（</span><span style="font-size: 10pt;">HIV-II</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Treponema pallidum</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">TP</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）：</span><span style="font-family: 新細明體,serif; font-size: 10pt;">梅毒螺旋體</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Transmissible spongiform encephalopathy</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">TSE</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）：</span><span style="font-family: 新細明體,serif; font-size: 10pt;">傳染性海綿狀腦病</span> </p> </td> </tr> <tr style="height: 85.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 452.85pt; padding-right: 1.4pt; height: 85.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="8"> <p><span style="font-family: 新細明體,serif; font-size: 10pt;">其他注意事項</span><span style="font-family: 新細明體,serif; font-size: 10pt;">：</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 9: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-family: 新細明體,serif; font-size: 10pt;">供人體移植醫療用的器官組織細胞的檢驗項目，其所擬輸入器官、組織、細胞之肝炎（</span><span style="font-size: 10pt;">Hepatitis</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）檢驗項目結果之一為陽性</span><span style="font-size: 10pt;">Postive</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">+</span><span style="font-family: 新細明體,serif; font-size: 10pt;">），若受贈者之肝炎檢驗對應項目亦為陽性</span><span style="font-size: 10pt;">Postive</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">+</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）之情況下，得敘明原因申請輸入。</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-family: 新細明體,serif; font-size: 10pt;">醫師應就移植所致之潛在感染危險性，盡詳實之告知義務。</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-family: 新細明體,serif; font-size: 10pt;">本署得依其他傳染病之發生，於必要時，公告自該疫區輸入之人體器官組織細胞者，應檢附之檢驗項目。</span> </p> </td> </tr> </tbody></table> 2013-12-04
1420506 其他類,捐血者健康標準 行政解釋 附表捐血者健康篩檢項目 <p style="margin: auto 0cm;" class="null"><b><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">附表　</span></b><b><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">捐血者健康篩檢項目</span></b> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 450.9pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">一、體重：女性應</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">45</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公斤以上，男性應</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">50</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公斤以上。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">二、體溫：口溫不超過攝氏</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">37.5</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">度。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">三、血壓：收縮壓</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">90</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">～</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">160</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">毫米汞柱，舒張壓</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">50~95</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">毫米汞柱，如兩者之距離低於</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">30</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">或高於</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">90</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">毫米汞柱，須經醫師許可。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">四、血液檢查</span> </p> <p class="044-1"><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">　&nbsp; (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">一</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血紅素：男性</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">13</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公克</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">%</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上（使用硫酸銅法時血液比重</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">1.054</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;"><br /> </span><span style="font-family: arial unicode ms; color: #333333; font-size: 9pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">女性</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">12</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公克</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">%</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上（使用硫酸銅法時血液比重</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">1.052</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p class="044-1"><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">　&nbsp; (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">二</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血小板：捐血小板者，其血小板數目應在</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">15</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">&times;</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">10,000/mm3</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上。</span> </p> <p class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">　</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">&nbsp; (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">三</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">) </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">白血球：捐白血球者，其絕對顆粒球數目應在</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">3,000/mm3</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上。</span> </p> <p class="044-1"><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">四</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">) </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血漿總蛋白：捐血漿者，應於首次捐血暨每隔半年加驗血漿總蛋白量，其血漿總蛋白應在</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">6g/d1</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">五、</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">ABO</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血型檢驗。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">六、</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Rh</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血型檢驗。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">七、紅血球異體抗體篩檢。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">八、血清轉胺酶檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">ALT</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">九、梅毒血清檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">STS</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">十、</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">B</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">型肝炎病毒表面抗原檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">HBsAg</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 30.1pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">十一、人類免疫缺乏病毒第一型、第二型抗體檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Anti- HIV-1/2</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 30.1pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">十二、</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">C</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">型肝炎病毒抗體檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Anti-HCV</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 30.1pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">十三、人類嗜</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">T</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">淋巴球病毒抗體檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Anti-HTLV-I/II</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> </td> </tr> </tbody></table></div> 2013-12-04
1420507 臨床試驗類,非臨床試驗優良操作規範 行政解釋 非臨床試驗優良操作規範 <p style="text-align: center; punctuation-wrap: simple;"><b><span style="font-family: 新細明體,serif; font-size: 14pt;">非臨床試驗優良操作規範</span></b><b> </b></p><p style="punctuation-wrap: simple;"><strong><span style="font-family: 新細明體,serif; font-size: 13pt;">﹝</span><span style="font-size: 13pt;">Good Laboratory Practice for Nonclinical Laboratory Studies</span><span style="font-family: 新細明體,serif; font-size: 13pt;">﹞</span> </strong></p><p style="punctuation-wrap: simple;">&nbsp;</p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第一章</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p style="vertical-align: top; punctuation-wrap: simple; 58: ;"><span style="font-family: 新細明體,serif;">一、</span>(<span style="font-family: 新細明體,serif;">一</span>) <span style="font-family: 新細明體,serif;">非臨床試驗優良操作規範</span>(<span style="font-family: 新細明體,serif;">以下簡稱本規範</span>)<span style="font-family: 新細明體,serif;">，係提供藥物研發評估，做為藥物查驗登記申請文件中的非臨床試驗應遵循之規範，以確保各項試驗數據之品質及試驗之完整性與可信度。</span> </p><p style="punctuation-wrap: simple; 55pt: ;"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (</span><span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">本規範未規定者或其他法令有特別規定者，適用其他有關法令之規定。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 9pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二、本規範專有名詞之定義如下：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 2.5pt; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">一</span>) <span style="font-family: 新細明體,serif;">實驗室優良操作規範</span>(Good Laboratory Practice, GLP)</p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">實驗室優良操作規範係指有關實驗室試驗之計畫、執行、監測、記錄、報告及檔案的組織架構及規範。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 2.5pt; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">非臨床試驗</span>(Nonclinical Laboratory Study)</p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 2.5pt 61.1pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">非臨床試驗</span>(<span style="font-family: 新細明體,serif;">以下簡稱試驗</span>)<span style="font-family: 新細明體,serif;">係指於實驗條件下之試驗體系，用活體內或</span><span>&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">活體外試驗來測試試驗物質的安全性。此試驗並不包括人體試驗或臨床試驗。亦不包括測試試驗物質是否具有任何潛在用途所作的基礎性研究。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">三</span>) <span style="font-family: 新細明體,serif;">試驗機構</span> (Testing Facility)</p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">試驗機構係指包括執行試驗所需之人員<span style="letter-spacing: -1pt;">、設施、設備及作業部門。</span></span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">四</span>) <span style="font-family: 新細明體,serif;">試驗機構管理階層</span><span> (Management)<br /></span><span style="font-family: 新細明體,serif;">試驗機構管理階層係指管理該試驗機構整體作業之負責人員。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">五</span>) <span style="font-family: 新細明體,serif;">試驗主持人</span><span> (Study Director)<br /></span><span style="font-family: 新細明體,serif;">試驗主持人係指執行該試驗之負責人。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">六</span>) <span style="font-family: 新細明體,serif;">試驗委託者</span><span> (Sponsor)<br /></span><span style="font-family: 新細明體,serif;">試驗委託者係指提供試驗之財務或其他資源；或將試驗結果向中央衛生主管機關申請藥物查驗登記之個人或法人，亦可為執行試驗之試驗機構。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">七</span>) <span style="font-family: 新細明體,serif;">品質保證單位</span><span> (Quality Assurance Unit)<br /></span><span style="font-family: 新細明體,serif;">品質保證單位係指為確保試驗符合本規範之規定，由試驗機構管理階層指定執行品質保證工作之未參與此研究之人員或組織。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">八</span>) <span style="font-family: 新細明體,serif;">試驗體系</span><span> (Test System)<br /></span><span style="font-family: 新細明體,serif;">試驗體系係指試驗中用來測試試驗物質或對照物質之動物、植物、微生物、細胞或其組成部份，化學或物理等體系或其合併體系。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">九</span>) <span style="font-family: 新細明體,serif;">試藥與溶液</span><span> (Reagents and Solutions)<br /></span><span style="font-family: 新細明體,serif;">試藥與溶液係包括試藥、試液、溶劑、指示劑、試紙、比色溶液及容量分析溶液等。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">十</span>) <span style="font-family: 新細明體,serif;">試驗物質</span><span> (Test Article)<br /></span><span style="font-family: 新細明體,serif;">試驗物質係指任何待測之藥物、化學、生物物質或其混合物。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 53: ;">(<span style="font-family: 新細明體,serif;">十一</span>) <span style="font-family: 新細明體,serif;">對照物質</span><span> (Control Article or Reference Article)<br /></span><span style="font-family: 新細明體,serif;">對照物質係指於試驗期間，用以與試驗物質比較之藥物、化學、生物物質或其混合物。</span> </p><p style="punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">十二</span>) <span style="font-family: 新細明體,serif;">賦形體</span> (Vehicle or Carrier)</p><p style="punctuation-wrap: simple; 48: ;"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">賦行體係指用於混合、分散或溶解之媒介物質，以利於試驗體系中試驗物質或對照物質之投予。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 58: ;">(<span style="font-family: 新細明體,serif;">十三</span>) <span style="font-family: 新細明體,serif;">批</span><span> (Lot (or Batch))<br /></span><span style="font-family: 新細明體,serif;">批係指如本規範第六章第一項所述之特定數量之試驗物質或對照物質，其具有均一之特性與品質。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 58: ;">(<span style="font-family: 新細明體,serif;">十四</span>)<span style="font-family: 新細明體,serif;">樣品</span><span> (Sample)<br /></span><span style="font-family: 新細明體,serif;">樣品係指定量之試驗物質或對照物質。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">十五</span>)<span style="font-family: 新細明體,serif;">標本</span><span> (Specimen)<br /></span><span style="font-family: 新細明體,serif;">標本係指由試驗體系衍生而來用於檢查或分析之物質。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">十六</span>)<span style="font-family: 新細明體,serif;">原始數據</span><span> (Raw Data)<br /></span><span style="font-family: 新細明體,serif;">原始數據係指於試驗過程中為整理或評估試驗報告所需保留之任何觀察結果、原始紀錄、文件或其精確複印本。原始數據可包括相片、微縮影片、電腦列印報表、磁性媒體及自動裝置等所得到之觀察數據或其紀錄。</span> </p><p style="punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">十七</span>) <span style="font-family: 新細明體,serif;">藥物</span><span> (Medicament)<br /></span><span style="font-family: 新細明體,serif;">依藥事法第四條之規定，係指藥品及醫療器材。藥品之定義依藥事法第六條、醫療器材之定義依藥事法第十三條。</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">三、</span><span style="font-family: 新細明體,serif;">試驗委託者對受託試驗機構之通知</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗委託者申請受託試驗機構進行試驗時，試驗委託者必須事先通知受託試驗機構遵照本規範進行試驗。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">四、查核</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構應接受中央衛生主管機關指定查核人員，進行包括依本規範之設施及保存之文書紀錄、標本等之查核；查核人員得影印或以其他適當方法複製該文書紀錄或其副本。</span> </p><p style="punctuation-wrap: simple;">&nbsp;</p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第二章組織與人事</span> </p><p style="punctuation-wrap: simple; 24pt: ;"><span>一、</span><span style="font-family: 新細明體,serif;">組織</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構內置試驗機構管理階層負責整體試驗之管理，且每一試驗計畫應有一試驗主持人負責試驗之執行，並應設品質保證單位稽查各項試驗工作以確保其執行過程均符合本規範之要求。</span> </p><p style="text-align: left; punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">二、人員管理</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 61.1pt; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">一</span>) <span style="font-family: 新細明體,serif;">參與執行的每一位人員及負有監督責任者必須具備相當之教育、訓練、經驗或兼具而能勝任其職務。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;">(<span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">應以書面制訂試驗機構內每一職位之工作職責，並應確實遵行之。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">三</span>) <span style="font-family: 新細明體,serif;">應保存實際參與試驗者之學歷背景、經歷、曾接受有關訓練及工作職責等之最新資料。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;">(<span style="font-family: 新細明體,serif;">四</span>) <span style="font-family: 新細明體,serif;">應依據試驗計畫書之要求，提供足夠之人員參與試驗工作。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">五</span>) <span style="font-family: 新細明體,serif;">應制訂新進及在職人員應有之訓練程序，以確保每一位試驗人員均能勝任其職務，且應將訓練內容及結果作成完整之紀錄。</span> </p><p style="punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">六</span>)<span style="font-family: 新細明體,serif;">試驗操作人員應注意個人衛生及健康，以防止污染試驗物質、對照物質及試驗</span><span>&nbsp; </span><span style="font-family: 新細明體,serif;">體系等。</span> </p><p style="punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">七</span>)<span style="font-family: 新細明體,serif;">參與試驗者發現罹患足以影響試驗可信度之疾病時，應報告其監督者，並避免參與試驗，與試驗物質、對照物質及試驗體系接觸，以免影響試驗品質及其完整性，直至其恢復健康狀況。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">八</span>)<span style="font-family: 新細明體,serif;">參與試驗者應配合工作性質穿著適當之工作衣物</span>(<span style="font-family: 新細明體,serif;">包括護鏡、保護衣、口罩、手套、鞋、襪等</span>)<span style="font-family: 新細明體,serif;">執行工作，並依需要經常換洗，以防止來自試驗物質、對照物質及試驗體系之微生物、放射性物質或化學性物質等之污染。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;">(<span style="font-family: 新細明體,serif;">九</span>)<span style="font-family: 新細明體,serif;">試驗</span><span style="font-family: 新細明體,serif;">人員應配合工作性質接受定期健康檢查。</span> </p><p style="punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">十</span>)<span style="font-family: 新細明體,serif;">試驗人員必須遵守實驗室安全及其有關規定執行試驗。</span> </p><p style="punctuation-wrap: simple; 27: ;"><span style="font-family: 新細明體,serif;">三、試驗機構管理階層</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">試驗機構管理階層應確保試驗機構依照本規範執行，並確保下列事項：</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）每一試驗開始前指定如本章第四項所述之試驗主持人負責該試驗之執行。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span>&nbsp;(</span><span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">試驗過程中視需要可即時更換試驗主持人，惟其更換事宜應作成書面紀錄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">三</span>) <span style="font-family: 新細明體,serif;">制訂實驗安全措施以確保實驗室安全。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span>&nbsp;(</span><span style="font-family: 新細明體,serif;">四</span>) <span style="font-family: 新細明體,serif;">設立如本章第五項所述之品質保證單位，並確保其功能符合本規範之規定。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">五</span>) <span style="font-family: 新細明體,serif;">試驗物質、對照物質或其混合物於必要時進行適當之鑑別，並測試其含量、純度、安定性及均一性等試驗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（六）人員、試驗材料、經費、設施、設備、材料及試驗方法均依既定計畫執行之。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（七）每一試驗均依既定之標準操作程序執行，而其安全及衛生規定皆符合國家有關法令之要求。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（八）試驗人員都確切明瞭其執行之工作。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（九）當試驗執行與本規範有所偏差時，品質保證單位應通知試驗主持人採取改善補救措施並作成書面紀錄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（十）必要時與試驗委託者共同同意試驗計畫書。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（十一）試驗計畫書、有關之標準操作程序及其制訂歷程檔案均妥善保存。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（十二）試驗計畫書之修訂確經同意並予以詳確記錄。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（十三）應指定一位經授權之人員負責檔案管理。</span> </p><p><span style="font-family: 新細明體,serif;">四、試驗主持人</span> </p><p><span style="font-family: 新細明體,serif;">試驗主持人應由具備相當教育、訓練、經驗或兼具之科技專業人員擔任。試驗主持人對試驗之執行及管制，試驗結果之解釋、分析、紀錄及報告等負整體之責任<b>，</b>並應確保下列事宜：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 24.45pt;"><span style="font-family: 新細明體,serif;">（一）試驗計畫書及其任何變更事項，均依照本規範第七章之規定執行。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（二）所有試驗數據包括試驗體系中非預期之觀察結果，均經詳確記錄及確認。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（三）試驗過程中，足以影響試驗品質及其完整性之突發狀況與所採取之補救措施，均經詳確記錄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（四）所使用之試驗體系符合試驗計畫書之規定。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（五）試驗程序均依本規範規定執行。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（六）所有原始數據、紀錄、試驗計畫書、標本及最終試驗報告等，於試驗過程或試驗終了均予以歸檔。</span> </p><p style="punctuation-wrap: simple; 51: ;"><span style="font-family: 新細明體,serif;">五、品質保證單位</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗機構應設品質保證單位，負責稽查試驗計畫之執行過程，以確保其設施、設備、儀器、人員、試驗方法、各項管制及紀錄等符合本規範之要求。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）執行品質保證工作人員應熟悉該試驗，且經相關訓練，並由不參與該試驗之人員擔任。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（三）品質保證單位之職責及作業程序：</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">1.</span><span style="font-family: 新細明體,serif;">負責保存一份所有在試驗機構裏進行試驗之主計畫進度表</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 新細明體,serif;">依試驗物質製作索引</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 新細明體,serif;">，內容包括試驗體系、試驗性質，試驗開始日期、各試驗階段、試驗委託者、試驗主持人姓名及最終試驗報告情形。</span> </p><p style="margin: 5.4pt 0cm 0pt 36.65pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">2.</span><span style="font-family: 新細明體,serif;">對負責稽查之試驗保存其試驗計畫書影本。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">3.</span><span style="font-family: 新細明體,serif;">定期稽查各試驗階段以確保所執行之試驗符合試驗計畫書及標準操作程序，將稽查試驗結果及內容、稽查所發現問題之缺失及改進措施與再稽查日期等製作成報告並簽署後保存。試驗期間應以適當的間隔進行稽查，以確保試驗之可信度及完整性。稽查過程中如發現影響試驗可信度及完整性之重要問題時，應立刻報告試驗主持人及試驗機構管理階層。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">4.</span><span style="font-family: 新細明體,serif;">應對負責稽查之試驗定期提出稽查試驗之現階段書面報告，簽具問題缺失及具體修正措施，並送交試驗機構管理階層及試驗主持人。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">5.</span><span style="font-family: 新細明體,serif;">應確定所稽查之試驗其執行與標準操作程序或核准之試驗計畫書無未經授權之任何偏差發生。</span> </p><p style="margin: 5.4pt 0cm 0pt 51.95pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">6.</span><span style="font-family: 新細明體,serif;">稽查最終試驗報告時應確定該報告正確地記載試驗方法，且其結果正確反映試驗之原始數據。</span> </p><p style="margin: 5.4pt 0cm 0pt 51.95pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">7.</span><span style="font-family: 新細明體,serif;">稽查終了應簽署一份報告，並併同最終試驗報告交送試驗機構管理階層及試驗主持人，於該報告中應載明稽查日期及稽查過程中所發現之缺失。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 61.1pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（四）品質保證單位之職責及其作業程序以及編索有關紀錄的方法均應制訂標準操作程序並保存遵行之。所有保存之紀錄應包括稽查日期、試驗名稱或代號、試驗階段及稽查者之簽名、簽註日期。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（五）所有品質保證單位保存之紀錄應存放於試驗機構備查。</span> </p><p style="punctuation-wrap: simple;">&nbsp;</p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第三章</span> <span style="font-family: 新細明體,serif;">設施</span> </p><p style="punctuation-wrap: simple; 24pt: ;"><span>一、</span><span style="font-family: 新細明體,serif;">一般規定</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構應具有適當之配置、空間及構造以利試驗之執行，且其設計須有適當程度之隔離，以避免任何功能或活動對試驗產生不良的影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24pt: ;"><span>二、</span><span style="font-family: 新細明體,serif;">動物管理設施</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）動物管理設施之設計、構造及配置應以對試驗之干擾降至最低為原則。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）為確保動物品種</span>(<span style="font-family: 新細明體,serif;">系</span>)<span style="font-family: 新細明體,serif;">或試驗體系之區分、個別計畫之獨立、動物檢疫之隔離、一般或特定動物之飼養，必要時應設足夠的動物飼養場所。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）當使用之試驗體系或試驗物質及對照物質具有生物危險性</span> (<span style="font-family: 新細明體,serif;">包括揮發性、放射性、傳染性物質及噴霧劑等</span>)<span style="font-family: 新細明體,serif;">時，應具足夠之動物飼養場所以供與前款之場所分開。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）應提供適當的場所作為診療及控制試驗動物疾病之用，且應提供已知或疑似染有疾病之動物、帶菌者與其他動物作有效隔離的場所。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（五）動物飼養場所應有收集及衛生處理試驗體系所產生之排泄物、廢棄物之設施，若無前述設施則於運出試驗機構前應予安全且衛生之儲存。該處理設施應具有將疾病、氣味、害蟲孳生和環境污染降至最低之功能。</span> </p><p style="margin: 6pt 0cm 0pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">三、動物用品供給設施</span> </p><p style="punctuation-wrap: simple; 12: ;"><span>&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">試驗機構內必要時應具備儲存飼料、床敷、墊料、飼養用品及器具之場所，且飼料、床敷及墊料的儲存場所與試驗體系之飼養場所應分開，以防止污染。易腐爛之用品或飼料應以適當方法儲存之。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">四、試驗物質及對照物質之管理設施</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（一）為防止污染及混淆，試驗機構應有下列區域：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">1.<span style="font-family: 新細明體,serif;">試驗物質及對照物質之驗收、儲存及處理場所。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">2.<span style="font-family: 新細明體,serif;">試驗物質、對照物質與賦形體之混和合場所。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span>&nbsp;&nbsp;&nbsp; 3.</span><span style="font-family: 新細明體,serif;">前述混合物之儲存場所。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）前款所列工作區域應與試驗體系之飼養場所隔離，並確保試驗物質或對照物質及其混合物之力價、純度、均一性及安定性。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">五、試驗操作區域</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構應具有足敷試驗所需之設施，且應視需要提供適當之隔離試驗場所，以執行所需之例行工作及特定工作，其試驗場所之設置條件應配合工作之需要。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">六、標本、紀錄與報告之管理設施</span> </p><p style="punctuation-wrap: simple; 18: ;"><span>&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">應提供存放與檢索所有試驗計畫書、原始數據、標本、樣品、文書紀錄與報告之場所，此場所非經授權不可進入。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">七、實驗室安全及廢棄物處理設施</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">實驗室之安全防護及廢棄物之處理應符合有關法令規章。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第四章</span> <span style="font-family: 新細明體,serif;">設備</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一、一般規定</span> </p><p style="margin: 6pt 0cm 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">（一）用於數據之產生、處理及評估之儀器或器具以及環境管制所需之機器，應具有適當的設計及足夠功能，且其配置應便於操作、檢查、清潔與維護。</span> </p><p style="margin: 6pt 0cm 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">（二）有關物理、化學及生物等各項試驗，應視其需要設置所需之設備，且其設置之條件應能配合工作需要，並妥為配置及維護。</span> </p><p style="margin: 6pt 0cm 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">（三）</span><span style="font-family: 新細明體,serif;">用於試驗之儀器及器材選擇以對試驗體系或試驗目的之干擾降至最低。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二、維護與校正</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）用於數據之產生、處理或評估之設備應予適當之清潔、定期維護及校正。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）有關設備定期之稽查、清潔、維護、測試、校正及標準化，應訂定相關標轉操作程序，並於該程序中詳載其方法、材料及時程。標準操作程序中對於前述各項工作應指定專人負責。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）前款設備經校正，若發現未能符合其精確度界限，應限制使用並採取補救措施。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）所有儀器操作、稽查、維護及校正紀錄均應予保存，前述紀錄應含各項工作之日期，並註明其操作維護是否依照既定之標準操作程序進行。若因儀器功能失常所執行之非例行性修護工作，其紀錄應記載該缺點發生時間、原因以及所採取之補救措施。</span> </p><p style="punctuation-wrap: simple; 61: ;">&nbsp;</p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第五章</span> <span style="font-family: 新細明體,serif;">試驗機構之操作</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一、標準操作程序</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）為提高試驗數據之品質及確保試驗之完整、安全性，應依本規範制訂各項標準操作程序，並經試驗機構管理階層核准後實施。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）標準操作程序應存放於各有關之試驗場所。其他發表之文獻、書籍或實驗手冊等可作為標準操作程序之補遺。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）試驗中各項操作與既定之標準操作程序有所偏差時應予記錄，並由試驗主持人作合理的判釋。重大的變更則必須經試驗機構管理階層授權，並保存書面紀錄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）標準操作程序修訂時，均應經試驗機構管理階層核准。有關標準操作程序之制訂歷程及修訂版應予保留。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（五）標準操作程序原則上需涵蓋下列各款有關項目：</span> </p><p style="punctuation-wrap: simple; 23: ;">1. <span style="font-family: 新細明體,serif;">器具之使用、維護、清潔及校正。</span> </p><p style="punctuation-wrap: simple;">2. <span style="font-family: 新細明體,serif;">機器及設備之使用與管理。</span> </p><p style="punctuation-wrap: simple; 23: ;">3. <span style="font-family: 新細明體,serif;">試藥及溶液之管制。</span> </p><p style="punctuation-wrap: simple; 23: ;">4.<span style="font-family: 新細明體,serif;">試驗物質及對照物質之管制。</span> </p><p style="punctuation-wrap: simple; 23: ;">5.<span style="font-family: 新細明體,serif;">試驗方法。</span> </p><p style="punctuation-wrap: simple;">6.<span style="font-family: 新細明體,serif;">動物及動物房之管理。</span> </p><p style="punctuation-wrap: simple;">7.<span style="font-family: 新細明體,serif;">實驗動物之鑑別、動物飼育室、配置及運送。</span> </p><p style="punctuation-wrap: simple; 23: ;">8.<span style="font-family: 新細明體,serif;">試驗體系之觀察及調查。</span> </p><p style="punctuation-wrap: simple; 23: ;">9.<span style="font-family: 新細明體,serif;">瀕死及死亡動物之處理。</span> </p><p style="punctuation-wrap: simple;">10.<span style="font-family: 新細明體,serif;">實驗動物之活體解剖及死體解剖之檢查。</span> </p><p style="punctuation-wrap: simple; 23: ;">11.<span style="font-family: 新細明體,serif;">標本之收集、鑑定及管理。</span> </p><p style="punctuation-wrap: simple; 23: ;">12.<span style="font-family: 新細明體,serif;">組織病理學之檢查。</span> </p><p style="punctuation-wrap: simple; 23: ;">13.<span style="font-family: 新細明體,serif;">紀錄與報告之管理。</span> </p><p style="punctuation-wrap: simple; 23: ;">14.<span style="font-family: 新細明體,serif;">品質保證工作之執行。</span> </p><p style="punctuation-wrap: simple; 23: ;">15.<span style="font-family: 新細明體,serif;">試驗安全衛生管制。</span> </p><p style="punctuation-wrap: simple; 23: ;">16.<span style="font-family: 新細明體,serif;">廢棄物處理。</span> </p><p style="punctuation-wrap: simple; 23: ;">17.<span style="font-family: 新細明體,serif;">其他有關事項之管制。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二、生物試驗體系</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）進口、購買、飼</span>(<span style="font-family: 新細明體,serif;">培</span>)<span style="font-family: 新細明體,serif;">養或使用動物、植物、微生物及細胞等，應依據國家相關法規辦理。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）動物、植物、微生物及細胞之購買、飼</span>(<span style="font-family: 新細明體,serif;">培</span>)<span style="font-family: 新細明體,serif;">養及使用應具有標準操作程序，並保存其紀錄以供追溯瞭解其使用歷程。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）新購進之動物、植物等在未評估其健康狀態前應予隔離檢疫，若觀察期間有異常疾病或死亡時，該批動物、植物等不得供試驗使用，並予適當處置。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）動物、植物、微生物及細胞等於試驗前，應經適當之適應期後始得供試驗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（五）在試驗開始時，動物不應有干擾試驗之任何疾病或不良健康狀況發生，若於試驗中有上述情形發生，則該動物應予隔離，必要時對已感染疾病或有疾病徵兆之動物應予治療，而此治療不得對試驗有任何干擾，診療過程及日期均應予記錄保存。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（六）試驗過程必須長期處理或觀察，或因各種原因必須從籠中取出或送回之溫血動物</span>(<span style="font-family: 新細明體,serif;">未斷乳之囓齒類動物除外</span>)<span style="font-family: 新細明體,serif;">，應有明確之識別方法。每一動物飼養容器外應有明顯之標識，以確認容器內每一試驗動物。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（七）不同品種</span>(<span style="font-family: 新細明體,serif;">系</span>)<span style="font-family: 新細明體,serif;">的動物必要時應分別飼養於個別的場所，而相同品種</span>(<span style="font-family: 新細明體,serif;">系</span>)<span style="font-family: 新細明體,serif;">用於不同試驗的動物，若可能因</span> <span style="font-family: 新細明體,serif;">不慎暴露於試驗物質、對照物質或其混合物而影響試驗結果時，原則上不可置於同一室，若必須置於同一室者，則應有適當空間之隔離及明確標示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（八）動物飼養場所、動物籠、架及其他附屬器皿、裝置等應定期清洗與衛生處理。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（九）動物籠或盤內所使用之床敷、墊料應不得干擾試驗目的或試驗進行，且應視需要予以更換，以保證動物處於乾燥和清潔之環境。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（十）動物飲水及飼料應定期分析，以確定對試驗產生可能干擾之污染物無超過試驗計畫書內規定的容許範圍，其結果應以原始數據之方式保存。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（十一）用殺蟲劑時應予記錄，若清潔劑及殺蟲劑會干擾試驗時則不可使用。</span> </p><p style="punctuation-wrap: simple; 24: ;"><span>三、</span><span style="font-family: 新細明體,serif;">藥與溶液之管制</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗中使用之試藥與溶液應標示其內容物、濃度、儲存條件、配製日期及有效期限。未標示有效期限之試藥與溶液應予重行檢驗。變質或超過有效期限者不得使用。</span> </p><p style="punctuation-wrap: simple; 24: ;">&nbsp;</p><p style="punctuation-wrap: simple; 37: ;"><span style="font-family: 新細明體,serif;">第六章</span> <span style="font-family: 新細明體,serif;">試驗物質及對照物質</span> </p><p style="punctuation-wrap: simple; 40: ;"><span style="font-family: 新細明體,serif;">一、試驗物質與對照物質之特性</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗開始前應確定每批試驗物質或對照物質之本質、力價、純度、組成或其他可以確切顯示該等物質之特性，並以記錄。試驗機構或試驗委託者應記錄試驗物質及對照物質之合成、製造方法或來源。若以市售商品為對照物質，可用其產品標示確認其特性。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）試驗機構或試驗委託者應在開始進行各項試驗前，確定試驗物質或對照物質之安定性；或依據既定之標準操作程序定期檢驗之。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）試驗物質及對照物質之每一貯存容器均標示其名稱、編號</span>(<span style="font-family: 新細明體,serif;">代碼</span>)<span style="font-family: 新細明體,serif;">、批號及有效期限，必要時應標示儲存條件。試驗過程中特定試驗物質應置於適當容器貯存之。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）試驗物質之留樣</span><span><br /></span><span style="font-family: 新細明體,serif;">試驗物質與對照物質每一批均應留存具代表性之儲備樣品，其存放條件應與標示者相同。儲備樣品之保存期限至少應予留存至試驗結束；當試驗期間超過四週時，向中央衛生主管機關申請藥物查驗登記者，其儲備樣品保存至核准上市後至少二年；其未申請者亦應保存至試驗完成或終止後至少二年。於儲存過程中易腐壞或不安定者應保存至該物質之品質可評估之最後期限。</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">二、試驗物質與對照物質之管制</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">應制訂試驗物質及對照物質之管制作業程序，並確保下列各事項</span> </p><p style="punctuation-wrap: simple; 24pt: ;"><span style="font-family: 新細明體,serif;">（一）適當之儲存。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）處理及輸送過程具有適當之標識，且確保未受任何污染、變質或損毀。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）具有驗收、取樣、儲存及處理之標準操作程序及紀錄，此紀錄應含品名、數量、日期及處理狀況。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">四、試驗物質、對照物質與賦形體之混合</span> </p><p style="punctuation-wrap: simple; 60: ;"><span style="font-family: 新細明體,serif;">（一）每批試驗物質、對照物質與賦形體之混合，應以適當方法分析下述各項：</span> </p><p style="margin: 0cm 5.65pt 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph5">1. <span style="font-family: 新細明體,serif;">確定試驗物質或對照物質與賦形體混合物之均一性，並定期測試混合物中試驗物質或對照物質之濃度。</span> </p><p style="punctuation-wrap: simple; 53: ;">2. <span style="font-family: 新細明體,serif;">依據試驗條件，在開始進行各項試驗前，應確定賦形體混合物中試驗物質或對照物質之安定性；或遵</span> <span style="font-family: 新細明體,serif;">照既定之標準操作程序定期檢驗之。</span> </p><p style="punctuation-wrap: simple; 60: ;"><span style="font-family: 新細明體,serif;">（二）試驗物質或對照物質之賦形體混合物中有一成分具有效期限，則應加以標示該期限，若不只一成分具有效期限者，應以其最早失效日期標示之。</span> </p><p style="punctuation-wrap: simple; 60: ;">&nbsp;</p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第七章</span> <span style="font-family: 新細明體,serif;">試驗計畫書及試驗之執行</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一、試驗計畫書</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）各項試驗應撰寫明確顯示試驗目的及方法試驗計畫書，並經試驗機構管理階層</span>(<span style="font-family: 新細明體,serif;">含試驗委託者</span>)<span style="font-family: 新細明體,serif;">核准及保存之。上述試驗計畫書得視需要記載下列有關事項：</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1.</span><span style="font-family: 新細明體,serif;">試驗名稱、性質及目的。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2.</span><span style="font-family: 新細明體,serif;">執行試驗之試驗機構及試驗委託者之名稱及住址。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3.</span><span style="font-family: 新細明體,serif;">試驗主持人姓名。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 4.</span><span style="font-family: 新細明體,serif;">主要測試人力需求。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5.</span><span style="font-family: 新細明體,serif;">試驗開始及結束預定日與預定進度。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6.</span><span style="font-family: 新細明體,serif;">對照物質及試驗物質應有足以識別之名稱、編號或代碼。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 7.</span><span style="font-family: 新細明體,serif;">試驗設計之敘述，包括取樣計畫及偏差管制的方法。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 8.</span><span style="font-family: 新細明體,serif;">試驗、分析及測量之種類及頻率。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 9.</span><span style="font-family: 新細明體,serif;">試驗體系選擇之理由。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 10.</span><span style="font-family: 新細明體,serif;">試驗體系之特性描述，例如生物之名稱、數量、體重範圍、年齡、性別、供應來源、品種、品系及其他有關資料。</span> </p><p style="margin: 5.4pt 0cm 0pt 53.65pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">11.</span><span style="font-family: 新細明體,serif;">試驗體系之識別法。</span> </p><p style="margin: 5.4pt 0cm 0pt 56.25pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">12.</span><span style="font-family: 新細明體,serif;">用於動物試驗過程中之溶劑、乳化劑、飼料、飲水等之敘述或鑑別。若已知上述物質中含有影響試驗結果之污染物質，則須明定該污染物質之容許範圍。</span> </p><p style="margin: 5.4pt 0cm 0pt 36.8pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">13.</span><span style="font-family: 新細明體,serif;">投予途徑及選擇該途徑之理由。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.25pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">14.</span><span style="font-family: 新細明體,serif;">投予劑量、方法及頻率。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">15.</span><span style="font-family: 新細明體,serif;">統計方法之敘述。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">16.</span><span style="font-family: 新細明體,serif;">試驗機構</span><span style="font-family: 新細明體,serif;">管理階層</span><span style="font-family: times new roman,serif;"> (</span><span style="font-family: 新細明體,serif;">含試驗委託者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 新細明體,serif;">之認可日期與試驗主持人之簽名及簽註日期。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">17.</span><span style="font-family: 新細明體,serif;">需保存紀錄與資料之項目。</span> </p><p style="margin: 1.5pt 0cm 0pt 61.1pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（二）經核准之計畫書需作任何修訂或變更時，均應經試驗主持人核准簽名及簽註日期，且需註明其修訂原因並與試驗計畫書保存之。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二、試驗之執行</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）任何試驗均應依據試驗計畫書及有關之標準操作程序執行，並予以追蹤管制。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）每一試驗均應有一明確的標示，試驗過程中所使用試藥、溶液及標本等應予明確之標示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">（三）標本應以適當方法標示試驗種類、試驗體系之編號及採集日期。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）解剖取得標本之肉眼觀察應予以記錄，以便執行組織病理學檢查之人員參考。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">（五）試驗所得到數據之記錄及變更，應遵循下列各事項：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">1.<span style="font-family: 新細明體,serif;">試驗過程中產生之數據，均應以不可塗銷之方法直接、迅速、清晰、正確地予以記錄，並簽名及簽註日期。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">2.<span style="font-family: 新細明體,serif;">自動數據收集系統產生之數據，於輸入時應由負責鍵入者予以確認簽名及簽註日期。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 5.4pt 61.1pt; punctuation-wrap: simple;">3.<span style="font-family: 新細明體,serif;">任何資料、數據於變更時亦應保留其原始數據，且註明變更原因、日期及確認者簽名。自動數據收集系統產生之數據，需變更時，應註明變更原因及鍵入者予以確認簽名及簽註日期。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（六）試驗進行中有任何異常或非預期之現象時，參與試驗人員應迅速向試驗主持人報告並詳細記錄之。</span> </p><p style="punctuation-wrap: simple; 61: ;">&nbsp;</p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">第八章</span> <span style="font-family: 新細明體,serif;">紀錄與報告</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一、最終試驗報告</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）每一試驗終了時均應依試驗計畫書撰寫最終試驗報告，內容至少需包括下列事項：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">1.<span style="font-family: 新細明體,serif;">試驗名稱、性質及目的。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">2.<span style="font-family: 新細明體,serif;">試驗機構單位名稱及地址。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">3.<span style="font-family: 新細明體,serif;">試驗之開始及完成日期。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 36: ;">4.<span style="font-family: 新細明體,serif;">試驗方法</span> (<span style="font-family: 新細明體,serif;">含觀察、測量、測試及分析之形式、頻率及方法</span>)<span style="font-family: 新細明體,serif;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">5.<span style="font-family: 新細明體,serif;">取樣及試驗過程中所產生數據之完整紀錄，包括自動設備輸出之原始資料。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">6.<span style="font-family: 新細明體,serif;">對照及試驗物質之名稱、編號或代碼、批號、力價、純度及組成或其他適當之特性描述以確認該等物質。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">7.<span style="font-family: 新細明體,serif;">試驗物質及對照物質於既定之投予條件下之安定性。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">8.<span style="font-family: 新細明體,serif;">試驗體系之特性描述，例如生物之名稱、數量、性別、體重範圍、供應來源、品種、及其識別程序。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 36: ;">9.<span style="font-family: 新細明體,serif;">投予劑量、途徑、頻率及投予期間之記載。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">10.<span style="font-family: 新細明體,serif;">試驗主持人及參與試驗人員姓名。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 48: ;">11.<span style="font-family: 新細明體,serif;">分析數據所用之統計方法。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 48: ;">12.<span style="font-family: 新細明體,serif;">可能影響數據品質及試驗完整性之因素。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">13.<span style="font-family: 新細明體,serif;">試驗數據之運算，分析及其導出之結論及試驗結果之評估判定與摘要</span>(<span style="font-family: 新細明體,serif;">包括參與試驗之主要專業人員簽名及簽註日期的個別報告</span>)<span style="font-family: 新細明體,serif;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 36: ;">14.<span style="font-family: 新細明體,serif;">標本、原始數據及最終試驗報告之儲存場所及期限。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">15.<span style="font-family: 新細明體,serif;">原始試驗計畫書之任何變更事項。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 5.4pt 36.65pt; punctuation-wrap: simple;">16.<span style="font-family: 新細明體,serif;">品質保證單位依本規範第二章規定作成之報告。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）試驗主持人應具結確認數據之真實性及試驗程序均依本規範規定執行，並於最終試驗報告簽名。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）最終試驗報告之補充或修正應由試驗主持人依一定程序修訂之，且於該報告中清楚顯示其為增補或修正部份，且載明其理由，並由修訂者簽名及簽註日期後由試驗主持人確認之。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二、紀錄及報告之儲存與追溯</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗產生之所有原始數據、標本</span>(<span style="font-family: 新細明體,serif;">致突變性試驗及血液、尿糞、生物體液之標本除外</span>)<span style="font-family: 新細明體,serif;">、紀錄文書、試驗計畫書和最終試驗報告應建檔並予保存。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）所有原始數據、標本、紀錄文書、試驗計畫書、中間及最終試驗報告均應依序存檔且利於追溯。其儲存狀況應以避免變質為原則，且保存場所應有降低至最小損害之設計；試驗機構亦可委託檔案保管機構提供其適當保存場所。若標本或原始數據與最終試驗報告分開建檔保存時，最終試驗報告之檔案應予詳確記錄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）紀錄及報告之儲存場所應有特定人員負責管理且非經授權不可進入。進出檔案室之物品應予記錄。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）因試驗規定必須儲存之物質及其有關資料應依序編索以利追溯，例如以試驗名稱、試驗物質、試驗日期、試驗體系及試驗本質等為索引。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">三、紀錄及報告之保存期限</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗產生之所有原始數據、標本、紀錄文書、標準操作程序及其制訂歷程、試驗計畫書和最終試驗報告等，向中央衛生主管機關申請藥物查驗登記者，保存至核准上市後至少五年；其未用於申請藥物查驗登記者亦應保存至試驗完成或終止後至少二年。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 48: ;"><span>&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 新細明體,serif;">（二）除前款規定外，溼性標本</span>(<span style="font-family: 新細明體,serif;">致突變性試驗及</span> <span style="font-family: 新細明體,serif;">血液、尿糞、生物體液得到之標本除外</span>)<span style="font-family: 新細明體,serif;">、試驗物質或對照物質樣品及經特別處理之物質，保存過程易顯著變質者，應保存至該物質可評估之最後期限。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）品質保證單位之主計畫進度表、稽查紀錄及負責稽查之試驗計畫書影本均應依序歸檔，並依本章第三項第一款之規定保存於品質保證單位。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）所使用儀器之檢查、保養及校正紀錄，應依本章第三項第一款之規定保存。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（五）依據本規範第二章之規定有關參與試驗</span><span>&nbsp; </span><span style="font-family: 新細明體,serif;">人員之職責、訓練過程及學經歷背景等資料應依本章第三項第一款之規定保存。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（六）本項之紀錄文書得以原始紀錄文書、相片、顯微影片、電子紀錄或其他精確產生之原始紀錄文書之真實複印本保存之。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（七）若試驗機構或委託檔案保管機構結束營運時，本項所述之所有原始數據、紀錄文書、及相關資料檔案應轉移繼任試驗機構；若無法定繼任者時，則轉移試驗委託者指定之檔案室。</span> </p> 2013-12-04
1420508 查驗登記類,指示藥品審查基準,驅蟲劑 行政解釋 指示藥品審查基準-驅蟲劑 詳如附件 2013-12-04 https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4508&type=0
總共 247 筆，顯示第 1 到第 50 筆