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CDE Consults on Pharmaceutical Products That Qualify for Biological Equivalence Exemption

 John Li  2017-11-14    2017-11-24

The Center for Drug Evaluation (CDE) of CFDA has published a list of basic pharmaceutical products that qualify for Biological Equivalence (BE) exemption or reduction for public consultations. Industry can submit their feedback before 11 Dec 2017.

The list of products have been assessed by technical experts and chosen based on their known quality and equivalent efficacy on humans.

关于公开征求《可豁免或简化人体生物等效性试验(BE)品种》意见的通知

为落实国家食品药品监督管理总局《关于仿制药质量和疗效一致性评价工作有关事项的公告》(2017年第100号)的要求,仿制药质量与疗效一致性评价办公室组织人员对289基药目录内品种进行了梳理和调研,并经国家食品药品监督管理总局仿制药质量和疗效一致性评价专家委员会审议,拟定了首批拟推荐豁免或简化生物等效性试验(BE)的品种名单(见附件),现向社会公开征求意见。 社会各界如有意见,请于12月11日前通过电子邮箱反馈至我办。

联系人:周誉,贺锐锐, 邮箱:zhouy@cde.org.cn , herr@cde.org.cn

Reference

http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314108

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