2018年5月2日 · The 2017 annual report of the European Medicines Agency published today provides an overview of the work of the European Medicines Agency (EMA) and highlights last year's major achievements in protecting and promoting public and …

This Act concerns the conservation and management of the environment in Malawi and prescribes environmental standards. It also concerns the conservation and management of biological (genetic) resources.

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In 2017, EMA and the national competent authorities (NCAs) established a new task force to explore how big data can be used to support research, innovation and robust medicines development for the benefit of human and animal health.

Authorisation of new medicines Overview of the key figures on the European Medicines Agency’s (EMA) recommendations for the authorisation of new medicines in 2017:

EMA 2017 was the 21st edition of the Slovenian national final format Evrovizijska Melodija (EMA). The competition was used by RTV Slovenija to select Slovenia's entry for the Eurovision Song Contest 2017, and consisted of three shows that commenced on 17 February 2017 and concluded on 24 February 2017.

Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for …

2017年9月19日 · 此前GMP办公室发布了EMA《制剂成品生产指南》-2017版的新闻，现在该指南已由GMP办公室翻译组-旺仔翻译，并校对完成。 现将它发布出来分享给大家。 Executive summary. 综述. 1. Introduction (background) 介绍（背景） 2. Scope 范围. This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation.

4 天之前 · Updated guidance is available for sponsors requesting joint scientific advice on clinical trial applications and evidence needs for marketing authorisation applications, which is provided by the Clinical Trials Coordination Group (CTCG) …

2018年3月5日 · 2017年10月26日，EMA发布了修订版的《临床试验用生物药品的质量文件要求指南》（Guideline on the requirements for quality documentationconcerning biological investigational medicinal products in clinical trials），该指南将于2018年4月26日生效。 为促进欧盟《人用药品临床试验法规》（EU No. 536/2014）的实施，由EMA授权，人用药品委员会（CHMP）生物制剂工作组对2012年4月15日生效的第一版指南进行了修订。 由于2014年以 …