摘要
通过解析美国FDA对新药申请的立卷审查制度,分析该制度的实施效果,探索其提高新药申请质量、提高审查效率与质量的方法,提出收获的几点思考,为完善我国新药形式审查制度提供参考。对于新药申请,FDA通过临床试验期间会议、申请提交前会议以及制定各种指南手册提高申请的质量,并通过规范化立卷审查流程提高审查的效率与质量。我国应重点提高新药申请的质量,加深形式审查的内涵,规范审评程序与相关指南,规范与申请人的沟通,从而提高新药申请的立卷通过率和首轮通过率,减少技术审评轮数,节约审评资源。
This paper summarizes the development history and current state of the pre-filing review policy of FDA,with focus on measures for the quality improvement of new drug application（ NDA） and biologic license application（ BLA） and standardization of the pre-filing review process,then introduces the effects of pre-filing review. It was found that formal meetings of pre-submission can effectively guarantee the quality of NDA and BLA,and good practice can effectively guarantee the quality and efficacy of the pre-filing review process for NDA and BLA. China has not established pre-filing review policy yet. It was suggested that different pre-filing review process be developed for NDA and abbreviated NDA（ ANDA） to improve the quality of NDA and BLA,enhance formal examination,and standardize the communication between the applicants and reviewers.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第6期627-633,644,共8页
Chinese Journal of New Drugs
关键词
立卷审查
审评规范
质量
提交前会议
pre-filing review
review practices
quality
pre-submission meeting
