Luke Nauth

Luke Nauth

Goodwin

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

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

6/28/2023  /  EU , European Commission , European Medicines Agency (EMA) , Orphan Drugs , Pharmaceutical Industry , Regulatory Reform , Regulatory Standards

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

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

5/23/2023  /  Data Protection , EU , European Commission , European Medicines Agency (EMA) , Exclusivity , Life Sciences , Marketing Authorization Application , Member State , Pharmaceutical Industry , Regulatory Standards

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

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

4/28/2023  /  EU , European Commission , European Medicines Agency (EMA) , Pharmaceutical Industry , Regulatory Reform , Regulatory Standards
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