浅析治疗用生物制品进口注册临床试验与国际多中心临床试验的关系

International multi-center versus registration clinical trial regarding therapeutic biologics: how to understand their relationship

现行《药品注册管理办法》中有关进口药物的申报和审批中规定:临床试验获得批准后,申请人应当按照药物临床试验及有关要求进行试验。本文拟就进口治疗用生物制品临床试验相关问题,如国际多中心临床试验与注册临床试验之间的相互关系,提出探讨性的意见。

It is stated in the current regulations for drug registration that, once clinical trial application from a foreign vendor is approved, the research should be conducted as required in the provisions. This paper pres- ents preliminary comments on the relationship between international multi-center and registration clinical trials re- garding the therapeutic biologics.