‘Regulatory Sandbox’ In EU's Sights For Innovative Drug Development & Approval

The European Commission’s vision for a more agile and streamlined drug development and assessment framework includes the use of controlled regulatory environments for testing innovative new drugs and technologies.

Child playing with his truck toy on a sunny summer day sandy background.
A sandbox could be used to drive regulatory innovation • Source: Shutterstock

The use of regulatory “sandboxes” to test out new approaches to the development and assessment of novel medicines could become widespread in the EU if proposals for the overhaul of the pharmaceutical legislation are approved.

Sandboxes could allow highly innovative products or technologies to be tested using novel regulatory tools as well as real-world evidence, with the necessary safeguards in place

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