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2.2.2 European Medicines Agency

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The EMA is the European Union (EU) body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision, and pharmacovigilance of medicinal products. The mission of the EMA is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health. The agency provides the Member States and the institutions of the EU the best‐possible scientific advice on any question relating to the evaluation of the quality, safety, and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products.5

Biologics, Biosimilars, and Biobetters

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