通用技术文件格式的申报资料中制剂主要研究信息汇总表的撰写

目的:对药物制剂通用技术文件(CTD)格式的申报资料中主要研究信息汇总表的总体要求和部分模块的撰写要求进行讨论,供药品注册申请人参考。方法:以原国家食品药品监督管理局颁布的主要研究信息汇总表撰写要求为基础,结合笔者日常的技术审评工作经验,通过举例的方法对重点模块的撰写进行示例。结果与结论:通过对主要研究信息汇总表的总体要求和重点模块,如"2.3.P.2产品开发"部分的"处方开发过程"和"生产工艺的开发"模块、"2.3.P.3生产"部分的"关键步骤和中间体的控制"和"工艺验证和评价"模块、"2.3.P.5制剂的质量控制"部分的"分析方法的验证"和"杂质分析"模块的示例讨论,可帮助药品注册申请人解决撰写主要研究信息汇总表时存在的问题,有助于提升注册申报资料的质量。

Summary Sheet Writing of Main Research Information in CTD Format Dossier of Pharmaceutical Products

OBJECTIVE： To discuss the general requirements of the summary sheet of main research information in Common technical documents （CTD） format dossier of pharmaceutical products and writing requirements of some modules, and to provide reference for drug applicants. METHODS ： Based on previous writing requirements of the summary sheet of main research information issued by China Food and Drug Administration, combined with the daily review experience of author, the writing of important modules were demonstrated by the way of example. RESULTS ＆ CONCLUSIONS ： In this article, it helps the applicants to solve the problems and improve the quality of the registration dossier by discussing the general requirements of the summary sheet of main research information and the important modules, including ＂formulation development＂ and ＂manufacturing technology development＂ in ＂2.3.P.2 product development＂, ＂manufacturing process control of critical steps and intermediates＂ and ＂process validation and evaluation＂in＂2.3.P.3 manufacture＂, ＂validation of analytical procedures＂ and ＂impurity analysis＂ in ＂2.3.P.5 quality control of the pharmaceutical products＂.