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What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?

 
• By Ian Schofield

Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

EU Europe and regulations
New regulations could disrupt the way novel drugs are developed in the EU • Source: Shutterstock

One of the key features of the European Commission’s proposals for revising the EU medicines legislation is a “regulatory sandbox,” which the commission describes as a “structured context” for testing innovative medicines and other medical technologies.

The sandbox, part of the commission’s plans for reducing the regulatory burden and providing a flexible framework to support innovation in the EU, could be set up if it was...

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