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