中华人民共和国疫苗管理法（征求意见稿）(94)
<P style="LINE-HEIGHT: 150%; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.0" class=MsoNormal><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（四）强化疫苗上市后研究管理。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">要求疫苗上市许可持有人制定并实施上市后风险管理计划，主动开展上市后研究</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第三十一条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">，</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">对上市疫苗开展质量跟踪分析，持续优化生产工艺和质量控制标准</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第三十二条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。对可能影响疫苗安全性、有效性的变更应当进行充分验证，并按规定报请批准、备案或者报告</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第三十三条）</SPAN></FONT><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">。</SPAN><FONT face="Times New Roman"><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">疫苗生产工艺落后、质量控制水平明显劣于同品种其他疫苗现有水平的，限期进行工艺优化和质量提升，规定期限内达不到要求的，予以退市</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第三十四条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。对产品设计、生产工艺、风险获益比明显劣于预防同种疾病的其他类疫苗的品种，予以淘汰</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第三十五条）</SPAN></FONT><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-SIZE: 16pt; mso-fareast-font-family: 楷体" lang=EN-US><o:p></SPAN></P>


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