Clinical Trials Regulation (EU) No 536/2014 Draft

Questions & Answers Version 4

In July 2021 European Commission published the draft Q&A guidance on EU clinical trials regulation.

The Q&As were discussed progressively since December 2014. Certain sections of this Q&A document are not yet complete. Updated versions of the Q&A will be published progressively.

Changes compared to superseded version, the Q&As guidance of the version 4 added or revised: Chapter 3 (complete revision), 11.6 (updated), 11.7 (updated), 11.14 (NEW), 11.15 (NEW), ANNEX IV changes to the source country (NEW).

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