This session explored key elements of the EU General Pharmaceutical Legislation (GPL) that aim to foster innovation and accelerate patient access to new treatments. Key focus included Platform Technology approaches and Regulatory Sandboxes.

By bringing together perspectives from patients, regulators, legislators, academia and industry, the discussion highlighted how these regulatory tools can support cutting-edge pharmaceutical development and manufacturing while keeping the EU region competitive and attractive for innovation.

This session provided a comprehensive regulatory and scientific perspective on how these approaches can drive the future of pharmaceutical development in Europe, ensuring faster access to innovation while maintaining regulatory scientific robustness.

A regulatory sandbox is a controlled framework that allows the testing of an innovative development in a controlled environment for a limited period of time.

The creation of a regulatory sandbox might be necessary when it is not possible to develop a medicinal product unless targeted adaptations or derogations to certain requirements are applied, under direct supervision of the relevant competent authorities.

The EC legal proposal is still under discussion with the Parliament and Council, and a final decision on inclusion of the Regulatory Sandbox in the EU pharmaceutical framework has not yet been reached.

However, as part of the Agency’s monitoring horizon scanning on future innovative products, informal ITF meetings with medicine developers may help to identify, at an early stage during development, potential case studies that could inform a regulatory sandbox approach in the future (if endorsed by the co-legislators). These meetings are:

• Early informal dialogue between medicine developers and regulators to gather information
• Not a pre-assessment of product eligibility for a future regulatory sandbox approach or any other procedure.

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/innovation-task-force-briefing-meetings#how-to-apply-76207

Points to note:

• Foreseen for MAA only at present
• R&D with Industry, Regulators, Patients and Academia involved
• Masterfile concept
• Patent protections to be considered in advance

Written by

Alice D’Alton