基于药品审评审批改革的药品上市许可转让程序构建研究

Research on Establishing the Procedure of Drug Marketing Authorization Transfer Based on Reform of the Drug Review

目的为设计上市许可制度中的许可转让程序提供建议。方法通过查阅文献及国内外法规,分析美欧日药品上市许可转让要素及程序。结果欧盟对药品上市许可转让实行审批制,美国和日本不对其进行审批,而是分别要求转让双方提交信息或受让方提交转让通知,三种管理方式均关注受让方与转让方责任交接的时间点、受让方承担上市许可持有人责任的承诺及药品相关资料的转移。结论我国在设计药品上市许可转让程序时应注意把握转让实质,实行简单的审批制,且监管部门在转让申请前及转让过程中与转让双方及时沟通。

OBJECTIVE To put forward several suggestions on designing procedure of authorization transfer in marketing authori- zation system. METHODS Domestic and foreign regulations and articles were searched. The elements and procedures of marketing authorization transfer in America, Europe and Japan were analyzed. RESULTS Marketing authorization transfer should be reviewed in Europe. In America and Japan, the transfer will not be reviewed, America requires the two sides of transfer to submit some information while Japan requires the transferee submit transfer notifications. These three managements all focus the transfer time of marketing authorization holder＇ responsibility, transferee＇s commitment of undertaking responsibility and the transfer of related documents. CON- CLUSION When design the procedure of marketing authorization transfer, the transfer essence should be catched, and a brief review should be conducted. Moreover, before and during the procedure, there should be some in - time communications between CFDA and two sides of transfer.