建立药品注册人员水平评价制度的必要性和可行性分析

On Necessity and Feasibility of Level Evaluation System of Drug Registration Personnel in China

目的:为我国建立药品注册人员水平评价制度提供必要性和可行性意见支持。方法:通过政策、现状及文献分析,研究建立药品注册人员水平评价制度的必要性和可行性。结果与结论:建立药品注册人员水平评价制度能够推动药品注册规范化、法制化以及药物研发创新和国际注册,能够提高药品注册申请和审评效率,加快推进药品注册国际化进程;同时,建立药品注册人员水平评价制度具备了一定的人员基础、制度基础、地方实践基础以及可借鉴的国外经验,亦具备了现实可行性。

Objective： To discuss the necessity and the feasibility of the level evaluation system of drug registration personnel in China. Methods： The necessity and the feasibility of the level evaluation system of drug registration personnel were discussed and studied through the analysis of policies, current status and literature review. Results and Conclusion： It is necessary to establish the level evaluation system of drug registration personnel in China which can promote the standardization and legalization of drug registration and improve the quality and effi ciency of the drug evaluation and speed up the pace of internationalization of drug registration. Meanwhile, the establishment of the level evaluation system of drug registration personnel has a certain professional, institutional, and local practical foundation with references from foreign experience, which is feasible in reality.