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European regulatory system medicines european medicines agency consistent approach medicines en 1

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The European regulatory system for medicines A consistent approach to medicines regulation across the European Union An agency of the European Union The European regulatory system for medicines A consistent approach to medicines regulation across the European Union This booklet explains how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network — a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) — works to ensure that patients in the EU have access to high-quality, effective and safe medicines. The EU regulatory system for medicines The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. This network is what makes the EU regulatory system unique. The network is supported by a pool of thousands of experts drawn from across Europe, allowing it to source the best possible scientific expertise for the regulation of medicines in the EU and to provide scientific advice of the highest quality. The diversity of experts involved in the regulation of medicines in the EU encourages the exchange of knowledge, ideas and best practice between scientists stri ...
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