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Regulatory Agenda › European Union › European Medicines Agency (EMA)

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

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From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

Hogan Lovells

EMA publishes list of COVID-19 treatments that have been the subject of the Agency’s guidance

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On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task...more

Hogan Lovells

EMA launches public consultation on the use of patient disease registries for regulator purposes

Hogan Lovells on

On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries...more

Hogan Lovells

Personalised Medicines at the top of the European Agenda

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In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare...more

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