欧洲药品局对在第三国进行临床试验的伦理和GCP问题的考虑

Consideration on the ethical and GCP issues of clinical trials in third countries of bureau of European Medicines Agency

众所周知,欧洲药品管理局(EMA)是欧盟的一个非集权实体,主要职责是通过审评和监督人用药品和兽用药品保护并促进公众和动物健康。欧洲药品管理局负责对药品的欧洲上市许可申请(集中程序)进行技术审评。对来源于欧盟以外的临床研究数据,如何保证受试者的合法权益,保证临床研究符合伦理和GCP的要求,成为欧洲药品局关注的一个问题。2009年,EMA起草了"对在第三国进行的人用药品临床试验中以及向欧洲药品管理局递交的上市许可申请中的伦理和GCP草案"并广泛征求意见,2010年9月在伦敦召开会议对草案进行了讨论。本文主要介绍该草案的基本情况以及会议讨论要点。

The European Medicines Agency（EMA） is a decentralised body of the European Union.Its main responsibility is the protection and promotion of public and animal health,through the evaluation and supervision of medicines for human and veterinary use.The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products（centralised procedure）.In 2009 the EMA established a Working Group on third country clinical trials on medicinal products for human use.Reflection Paper on ethical and Good Clinical Practice（GCP） aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA responds to the challenges arising from the increasing globalisation of clinical research.The workshop held on 6-7 September 2010 was part of the consultation process.