结合药品注册检验受理常见问题解读与之相关规章

Interpretation of Relevant Regulations on Drug Registration Inspection in Combination with Common Problems in Inspection Acceptance

目的:针对药品注册检验受理工作中出现的问题,研究分析新修订的《药品注册管理办法》及其配套文件《药品注册检验工作程序和技术要求规范(试行)》(2020年版),提出后续工作的参考建议。方法:从多个方面结合受理常见问题对有关规定和要求进行解读,对药品注册检验相关规章在实施细则和技术要求上有待完善之处进行探讨并提出修订思路。结果:受理常见问题主要涉及注册检验适用范围、注册检验分类、注册检验要求、送检时限、样品受理、二次检验等方面,反映出药品注册申请人对药品注册检验相关规章的理解和领悟需要加强。结论:《药品注册管理办法》和《药品注册检验工作程序和技术要求规范(试行)》(2020年版)的实施,进一步优化了药品审评审批工作流程,促进了药品注册检验规范化开展,加快了药品上市的进程,但仍然存在一些不足需要通过修订来不断完善。

Objective:To study and analyze the newly revised“Provisions for Drug Registration”and its supporting document“Specifi cations for Working Procedures and Technical Requirements for Drug Registration Inspection(Trial,2020)”in view of the common problems arising in the acceptance of drug registration and inspection,and put forward references and suggestions for follow-up work.Methods:In combination with common problems in inspection acceptance,the relevant regulations and requirements were interpreted from many aspects,the implementation rules and technical requirements of the relevant regulations on drug registration and inspection were discussed,and the revision ideas were put forward.Results:Common problems in inspection acceptance mainly involved the scope of application of registration and inspection,the classifications of registration and inspection,the requirements of registration and inspection,time limit for submission of registration inspection,sample acceptance,registration inspection for the second time,etc.,which reflected that the drug registration applicants need to strengthen the understanding of relevant regulations on drug registration and inspection.Conclusion:The implementation of“Provisions for Drug Registration”and“Specifi cations for Working Procedures and Technical Requirements for Drug Registration Inspection(Trial,2020)”further optimized the working procedure of drug review and approval,promoted the standardization of drug registration and inspection,and accelerated the drug licensing process.However,there are still some defi ciencies that need to be corrected through revision.