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中华人民共和国疫苗管理法(征求意见稿)(65)
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0; punctuation-wrap: simple" class=a><FONT size=5><SPAN style="LAYOUT-GRID-MODE: line; FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-family: 黑体; mso-bidi-font-size: 16.0pt; mso-font-width: 0%" lang=EN-US><SPAN style="mso-list: Ignore">第六十九条</SPAN></SPAN><SPAN style="FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">【全生命周期监管体系】</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 黑体; mso-bidi-font-size: 16.0pt"> </SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt"><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">药品监督管理部门会同卫生行政部门对疫苗实行全生命周期监督管理,加强疫苗监管体系能力建设,对疫苗的研制、上市、上市后研究评价、变更和许可延续,以及疑似接种异常反应监测工作进行监督管理,监督上市许可持有人履行法律责任,促进企业不断完善生产工艺和改进产品质量,提高疫苗安全性和有效性保障水平。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><o:p></SPAN></FONT></FONT></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; mso-line-height-rule: exactly; mso-char-indent-count: 2.0; punctuation-wrap: simple; mso-layout-grid-align: none" class=a><FONT size=5><SPAN style="LAYOUT-GRID-MODE: line; FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-family: 黑体; mso-bidi-font-size: 16.0pt; mso-font-width: 0%" lang=EN-US><SPAN style="mso-list: Ignore">第七十条</SPAN></SPAN><SPAN style="FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">【检查机构和检查员</SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">】</FONT></SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">国务院和省、自治区、直辖市药品监督管理部门设立专门检查机构,建立职业化检查员队伍,加强疫苗监督检查。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><o:p></SPAN></FONT></FONT></P>


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