新版《药品注册管理办法》修订内容研究与思考

Revisions of the new “Provisions for Drug Registration” in China and some considerations

本文旨在阐明新版《药品注册管理办法》的修订过程、修订思路和创新点、主要修订内容等,以期为药品注册工作提供参考。对比2007年版《药品注册管理办法》,结合新修订《中华人民共和国药品管理法》和《中华人民共和国疫苗管理法》的新制度要求,加之比较法的视角,对2020年版《药品注册管理办法》进行研究和解析。新版《药品注册管理办法》落实了新法精神,固化了药品审评审批制度改革成果,调整和优化了药品注册程序,加大了信息公开力度,有助于进一步鼓励创新,提高审评审批工作效率。

The aim of the article was to outline the process of revisions of the new "Provisions for Drug Registration",considerations and innovations,as well as its main contents of revisions,in order to provide references for those engaged in regulatory affairs and contributing to its better understanding and utilization in the actual work.The Provisions( 2020 version) was studied and interpreted by performing a comparison between this version and the previous one( 2007 version),considering the requirements of news systems in the "Drug Administration Law of the People’s Republic of China"and the "Vaccine Administration Law of the People’s Republic of China". The new version has implemented the requirements of the above-mentioned new laws,incorporated the achievements of reforms of the drug review and approval system,as well as adjusted and optimized the procedures for drug registration.It also helps disclose information in a more transparent manner,contributing to further encouragement of innovations and enhanced efficiency on drug review and approval.