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Jul 10, 2018 · Medicines for Europe president Marc-Alexander Mahl outlines the challenges facing the generic, biosimilar and value-added medicines industry and its role in achieving sustainable healthcare Medicines For Europe (formerly EGA) represents the European generic, biosimilar and valued added pharmaceutical industries The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications EMA's opinion refers to its scientific recommendation, upon which the European Commission bases its legal decision to grant an EU-wide marketing authorisation About the Generic Medicines Group The Generic Medicines Group is a sector group of Medicines for Europe, representing the generic medicines developers and manufacturers, which provide high-quality cost-competitive medicines to millions of patients in Europe and around the world Over 400 manufacturing and research & development sites across Europe produce your essential medicines, employ over EU pharmaceutical law governs how medicines are authorized, manufactured, distributed and monitored across Europe This guide explains key legislation, including Directive 2001 83 EC and the Clinical Trials Regulation, outlines legal requirements across the product lifecycle, offers a practical compliance checklist, and previews upcoming reforms affecting European pharma companies --- medicineseurope comOct 22, 2026 · Updated daily · official EMA data EMA Drug Approvals Tracker Every EU marketing authorisation from the last 12 months - new medicines, biosimilars and generics approved centrally through the European Medicines Agency - plus CHMP positive opinions still awaiting a European Commission decision