仿制药申报新出路，EU尝试跨国分散审评

一沙一叶

Europe to boost international cooperation on generics

欧洲促进仿制药的国际合作

EMA to share assessments reports for generic medicines with regulators outside the EU

EMA将要与EU之外的监管部分分享仿制药的评估报告

The European Medicines Agency (EMA) is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU). This initiative aims to facilitate the timely authorisation and availability of safe, effective and high quality generic medicines worldwide.EMA准备与EU之外的法规部门合作实时分享仿制药申请的评价。这个行动的目标是为了便于世界上安全有效高质量的仿制药的及时授权和应用。

The information-sharing initiative is part of the International Generic Drug Regulators Pilot (IGDRP). It started in July 2014 using the European Union decentralised procedure as a model, and it is now extended to the centralised procedure.信息分享行动是International Generic Drug Regulators Pilot (IGDRP)的一部分。它开始于2014年，以欧盟的分散审评程序为模型，现在延伸到了集中审评程序。

The EU is leading this initiative with the aim to both save global assessment resources and to facilitate and strengthen the scientific assessment process for medicines. It is expected that this sharing of assessments will allow authorisation of generic products in concerned countries in a coordinated and resource effective way.EU领导这个行动的目标既是为了节约全球的评估资源，也是为了方便和加强药品的科学评估。评价的分享希望能够在这些国家以协调的、充分利用资源的方式来批准仿制药。

The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland. Other members of the IGDRP may decide to take part in the pilot programme at a later stage. These include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa. The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization (WHO) participate to IGDRP as observers.这个项目第一阶段会包括EU、澳大利亚、加拿大、中国台北和瑞士。其它IGDRP在以后阶段可能决定参加这个项目。这些国家包括巴西、中国、日本、韩国、墨西哥、新西兰、俄罗斯、新加坡和南非。EDQM和WHO作为观察国参与。

In the initial phase, 10 applications for generic medicines will be selected for participation in the pilot; further products might be considered after evaluation of first results.在最初阶段，将会有10份仿制药的申请被选中参与这个项目；在最初的结果评估之后，将会有更多产品参与。

Companies are invited to express their interest in participating in the pilot programme. Further information has been published today on the EMA website.公司被邀请参与表达他们参与这个项目的兴趣。EMA网站会公布进一步的信息。

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002251.jsp&mid=WC0b01ac058004d5c1

yanzhengren

学习了，谢谢。