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European Commission European Medicines Agency (EMA) Member State

Goodwin

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

Goodwin

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

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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

Cooley LLP

European Commission Publishes Proposals to Revise Current EU Pharmaceutical Legislative Framework

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Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

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Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 42

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LATEST KEY DEVELOPMENTS - Competition & State Aid • European Commission issues Comfort letter on Cooperation at a Matchmaking Event – Towards COVID19 vaccines upscale production • European Commission publishes...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 41

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LATEST KEY DEVELOPMENTS - Competition & State Aid • Commissioner McGuinness addresses EU’s bank crisis management and deposit insurance framework, including COVID-19 crisis and State aid concerns • EU approves...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 28

Jones Day on

LATEST KEY DEVELOPMENTS - Competition & State Aid • EU approves new and amended Member State measures to support the economy • Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more

Jones Day

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

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On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more

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