EDQM新闻：TGA加入EDQM的CEP评估程序----Julia

巴西木

官网原文：http://www.edqm.eu/en/TGA-joins-EDQM-s-CEP-assessment-process-1587.html?mbID=20626 June 2014
TGA joins EDQM’s CEP assessment process

The European Directorate for the Quality of Medicines and HealthCare (EDQM) and the Australian Therapeutic Goods Administration (TGA) are strengthening their collaboration related to the procedure for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP).

EDQM和澳大利亚TGA加强其在CEP方面的合作。

In May 2014, the CEP Steering Committee accepted the request from the TGA to actively participate in the scientific assessment of applications submitted by manufacturers to obtain aCEP.  This will allow the Australian authority to get a more detailed insight into the CEP procedure and to exchange best practices, skills and experience with international colleagues. The TGA has been accepting CEPs for a couple of years already

2014年5月，CEP指导委员会接受了TGA要求参与CEP申报资料科学评审的申请。这使得澳大利亚可以对CEP程序有更详细的了解，同时与国际同行在操作规范、技能和经验方面进行交流。TGA在多年前已经接受CEP。

syhorchid

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xqliu

学习一下啦，谢谢提供分享。