| [GMP] EMA將要與EU之外的監(jiān)管部分分享仿制藥的評估報告 |
Europe to boost international cooperation on generics
歐洲促進仿制藥的國際合作 EMA to share assessments reports for generic medicines with regulators outside the EU EMA將要與EU之外的監(jiān)管部分分享仿制藥的評估報告 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準備與EU之外的法規(guī)部門合作實時分享仿制藥申請的評價。這個行動的目標是為了便于世界上安全有效高質量的仿制藥的及時授權和應用。
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. 信息分享行動是International Generic Drug Regulators Pilot (IGDRP)的一部分。它開始于2014年，以歐盟的分散審評程序為模型，現(xiàn)在延伸到了集中審評程序。
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領導這個行動的目標既是為了節(jié)約全球的評估資源，也是為了方便和加強藥品的科學評估。評價的分享希望能夠在這些國家以協(xié)調的、充分利用資源的方式來批準仿制藥。
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. 這個項目第一階段會包括EU、澳大利亞、加拿大、中國臺北和瑞士。其它IGDRP在以后階段可能決定參加這個項目。這些國家包括巴西、中國、日本、韓國、墨西哥、新西蘭、俄羅斯、新加坡和南非。EDQM和WHO作為觀察國參與。
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. 在最初階段，將會有10份仿制藥的申請被選中參與這個項目；在最初的結果評估之后，將會有更多產品參與。
Companies are invited to express their interest in participating in the pilot programme. Further information has been published today on theEMA website. 公司被邀請參與表達他們參與這個項目的興趣。EMA網站會公布進一步的信息。
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