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EU Regulatory Round-Up: RWE Platform Proposed, Brexit Transition Update, EPI Principles Published

Mar 23 2020

The latest EU regulatory developments - EMA and HMA are looking to build an EU-wide real-world data platform; EU OTC firms can operate as normal in the UK until the end of the year; EMA, HMA and the EC have published key principles on how to develop and use electronic product information for medicines marketed within the EU.

3d render of Europe map Earth globe — • Source: Shutterstock

The European Medicines Agency – in partnership with the Heads of Medicines Agencies (HMA) – is one step closer to establishing a regulatory framework and platform for harnessing real-world data (RWD) and real-world evidence (RWD).

Named DARWIN for short, the Data Analysis and Real-World Interrogation Network “will deliver a sustainable platform to access and analyse...