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Data Protection European Medicines Agency (EMA)

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

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 104

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 103

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...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

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. 39

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LATEST KEY DEVELOPMENTS Competition & State Aid • European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic • EU approves new...more

Jones Day

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

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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

Smart & Biggar

Biosimilars: Comparison chart between Canada, US and Europe

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As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more

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