FDA新药审评中补充资料的沟通交流机制研究及启示

FDA information request mechanism during new drug application review and some reference points for China

通过查阅美国的法律法规、FDA行业指南和内部标准操作程序,本文深入分析FDA在新药审评中的多种补充资料沟通交流机制,为完善我国在新药审评中补充资料的机制设计提供借鉴意义。FDA通过信息请求函和专业审评函实现单轮审评间较灵活的补充资料方式,通过完整回复函实现单轮审评结束后中立的补充资料方式,并且对不同类别的补充资料在流程设计上分类考虑。这些制度设计值得我国在新修订《药品注册管理办法》时予以借鉴吸收。

By referring to the drug-related laws and regulations in the United States,FDA industry guidance and standard operating policy and procedures,we deeply analyzed the information request mechanism on FDA＇s new drug review process to provide references for China＇s new drug review mechanism design. FDA requires information during a review cycle by sending information request letter and discipline review letter,and sends complete response letter if the application cannot be approved in its present form. FDA also designed different process for different amendments and resubmissions. These systems can provide references for CFDA in amending＂provisions for drug registration＂.