21/10/2026
Policy update | How can regulatory sandboxes support the next generation of medicines?
A regulatory sandbox establishes a time-limited framework in which developers can design, validate and test innovative medicines or methodologies in a controlled, real-world environment, under strict regulatory oversight.
What does this mean for EU pharmaceutical legislation?
The new framework allows regulatory sandboxes to be considered when genuine scientific or technical barriers prevent the development of innovative medicines under existing requirements. The aim is to explore targeted regulatory adaptations and generate learnings for future regulatory approaches, without compromising quality, safety or efficacy.
๐ค On 21 September 2026, the European Commission (EC) and the European Medicines Agency (EMA) held a multi-stakeholder workshop to discuss how regulatory sandboxes can be implemented in practice.
Explore the presentations: https://www.ema.europa.eu/en/events/regulatory-sandboxes-joint-european-commission-ec-european-medicines-agency-ema-multi-stakeholder-workshop