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European Medicines Agency

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Impact of Brexit on marketing authorisation holders – new EMA and CMDh guidance

Posted on June 7, 2017

The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA…

FDA / EMA parallel scientific advice principles published

Posted on June 1, 2017

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products.

The PSA program provides scientific advice and…

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