Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 102

Like the US FDA, the EMA’s main responsibility is the protection and promotion of public and animal health through the evaluation, supervision and safety monitoring of medicines throughout the European Union. The EU comprises 27 countries (Member States), as well as the three European Free Trade Area (EFTA) nations of Iceland, Liechtenstein, and Norway. These 31 countries are also referred to as the European Economic Area (EEA).

Switzerland also works closely with the EMA, particularly in areas regarding inspections, but is not within the EU.

Due to Brexit, the EMA moves to Amsterdam, The Netherlands and the number of EU countries will be back to 27. Even if all players are working for a smooth transition, we can expect some difficulties in the functioning of the EMA for a few years.