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

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".