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European Commission › European Medicines Agency (EMA) › Regulatory Reform

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The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

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In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

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The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Orphan Medicines

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We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years

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On 26 April 2023, the European Commission published two legislative proposals - a new Regulation 2023/0131 and a new Directive 2023/0132 - to replace the current EU regulatory framework for all medicines (including those for...more

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