药品注册审评过程中注册检验常见问题分析及思考

Analysis and Reflection on Common Issues in Registration Inspection during Drug Registration Review Process

关键词:  药品  注册审评  注册检验  常见问题

Key words:  drug  registration review  registration testing  common problems  

摘要:

目的：通过对药品注册审评过程中常见的注册检验问题进行汇总,对共性问题进行分析和讨论,为注册申请提供帮助,以进一步提高研发审评的质量和效率。方法：结合当前政策法规以及药品注册检验要求,对注册审评过程中申请人来文咨询及一般技术问题咨询中关于注册检验问题进行归类分析,从注册检验启动的情形、注册审评过程中注册检验要求、原辅包注册检验启动、以及审评过程中基于审评需要的注册检验的问题等方面进行阐述。 结果与结论:申请人在申报注册申请前按照药品审评机构及药品检验机构对注册检验的要求完成注册检验的相关准备工作,药品监管机构进一步完善注册检验规范、程序,以期实现加快审评以及审评审批总时限可预期。

Abstract:

Objective: To summarize the registration testing problems frequently consulted by the applicant in the process of drug registration review,the common problems are analyzed and discussed to provide reference for the applicant , so as to further improve the efficiency of registration review. Methods: Combined with the current laws and regulations as well as the requirements of drug registration testing, the problems found during the registration testing of registration review process for drug registration were classified and analyzed. The aspects of the situation of starting the registration testing, the requirements for registration inspection during the registration review process, the starting of the original and auxiliary package registration testing, and the problems of the secondary registration testing were described. Results and Conclusion： The applicant should complete the relevant preparations for registration testing according to the requirements of the drug evaluation institution before applying for registration,and the drug regulatory authority should further improve the registration testing specifications and procedures, with a view to accelerating the review and the expected total time limit for review and approval.