Q&A: New Rules for Clinical Trials conducted in the EU

Recommendation
18-20 November 2025
Heidelberg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
Following the positive vote in Parliament for the new Clinical Trial Regulation, the EU Commission has published a set of Q&As on clinical trials.
Here it is also discussed why the current legislation is being replaced and the main changes are summarised:
- The new authorisation procedure
- The simplified reporting procedures
- More rights for the Commission to conduct controls
In the new regulation, the concept of tacit agreement in the assessment phase of an application will be extended. According to the Q&A, this was needed "to avoid bottlenecks and delays in the procedure".
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