Europe launches pilot to streamline approvals

The European Commission has launched a pilot program to simplify the approval process for certain clinical studies conducted across multiple European Union (EU) countries. The initiative aims to streamline applications, allowing sponsors to submit a single request for coordinated assessment.

By centralizing interactions with national authorities, the program seeks to create a more predictable process for approvals. It is designed to reduce administrative burdens, improve communication between countries, and ensure greater consistency in decision-making.

Sponsors can engage with all participating EU states simultaneously, avoiding delays caused by differing national interpretations. The program also aims to standardize requests for additional information, making the process more efficient.