中华人民共和国疫苗管理法（征求意见稿）(93)
<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">（二）加强疫苗上市监管。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">强调生物安全控制和菌毒株、细胞株管理</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第十四条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。临床试验应当由三级医疗机构或者省级以上疾控机构实施或者组织实施</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第十五条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">，要求疫苗临床试验实行更加特殊的受试者保护，<SPAN style="COLOR: black; mso-bidi-font-weight: bold">审慎选择受试者，合理设置受试者群体和年龄组；受试者为限制民事行为能力人的，应当获得受试者本人及其监护人的书面知情同意</SPAN></SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第十六条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。明确国务院药品监督管理部门在批准疫苗上市时对疫苗生产工艺和质量控制标准以及说明书、标签一并予以核准，并对说明书的公开与持续更新作出规定</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第十九条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-SIZE: 16pt; mso-fareast-font-family: 仿宋_GB2312" lang=EN-US><o:p></SPAN></FONT></P>
<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">（三）实施更加严格的生产管理</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。对疫苗生产实施严格准入管理，要求有足够的产能储备以应对紧急情况下的供应需求，要求法定代表人、主要负责人应当具有良好信用记录，其他关键岗位人员应当具有相应的专业背景、从业经历</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第二十条、第二十一条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。疫苗一般不得委托其他企业生产</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 楷体_GB2312; FONT-SIZE: 16pt">（第二十二条）</SPAN><SPAN style="LINE-HEIGHT: 150%; FONT-FAMILY: 仿宋_GB2312; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'">。对疫苗实施批签发管理，每批产品上市前应当经过批签发机构的审核、检验</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: 楷体_GB2312; FONT-SIZE: 16pt">第二十五条、第二十六条、第二十七条）。<o:p></SPAN></SPAN></FONT></P>


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