以品种为核心的仿制药一致性评价工作模式探讨

Discussion of the product based supervision mode for the quality and efficacy consistency evaluation of generics

在深化药品审评审批制度改革新形势下,本文探讨以品种为核心的仿制药质量和疗效一致性评价工作模式。以总局2017年第100号公告要求为依据,结合其他相关的政策要求,分析讨论上海药品审评核查中心如何在一致性评价工作中实现监管和服务两方面的职能,形成以品种为核心的监管职能和服务工作的清单,为今后的工作积累经验。

In order to improve the supervision efciency, we are trying to develop a product based supervision mode for the quality and efficacy consistency evaluation of generic drug. Based on the requirements of Announcement No. 100 of 2017 from CFDA and other relevant policy requirements, Shanghai Center for Drug Evaluation and Inspection is continuously improving its work strategy in order to better take the responsibilities on both supervision and service, listing the working responsibilities of Shanghai Center for Drug Evaluation and Inspection, and providing experience for future work.