EC and EMA Invite to Workshop on Regulatory Sandboxes

The European Commission (EC) and the European Medicines Agency (EMA) will jointly host a multi-stakeholder workshop on September 21, 2026, focusing on the implementation of regulatory sandboxes. This new mechanism is part of the revised EU legislation on medicinal products and aims to facilitate the development and market access of innovative medicines.

The workshop will provide a platform for discussions on how regulatory sandboxes can effectively be utilized to expedite the regulatory pathways for novel therapies. Representatives from both regulatory bodies and the pharmaceutical industry are expected to share their perspectives and experiences with this emerging tool.

The event aims to foster a dialogue among key stakeholders, including regulatory authorities, pharmaceutical companies, and healthcare professionals. The goal is to establish a shared understanding of how these sandboxes can support medical innovation while ensuring patient safety.

Discussions are anticipated to cover potential challenges and best practices for navigating the regulatory processes for groundbreaking treatments. This initiative marks a significant step towards adapting the EU's regulatory framework to better accommodate and encourage pharmaceutical advancements.