Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 101

In 1995, the European Medicines Evaluation Agency (EMEA) now called European Medicines Agency (EMA) but also “the Agency” was created and based in London, England but has moved to Amerstdam, The Netherlands. Now, over two decades later, the face of drug regulation in Europe has totally changed. In 2010, a new PV Regulation was issued generating hundreds of associated Directives, Guidances, Q&A etc. This “tsunami” continues to evolve with ongoing new or updated regulatory documents which continue to be published. In addition, Brexit and the EMA move to Amsterdam — is generating further turbulence in both the EMA organization and its functioning. See the very extensive website of the EMA (http://www.ema.europa.eu/ema/). We will examine the EMA in detail and take a brief look at one member state’s Health Agency: France.