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What is the EU Clinical Trial Regulation?

Nurse performing weight check — NIH History Office

The Clinical Trials Regulation (Regulation (EU) No 536/2014) (CTR) was enacted on April 16, 2014 and entered into force on June 16, 2014.

The timing of its application however depends on the development of a fully functional EU clinical trials portal and database.

  • The Regulation described that the full functionality of the portal needed to be verified by the European

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