EU Clinical Trials Regulation

Published: 2/2/2022

European Union pharmaceutical legislation known as the Clinical Trials Regulation

The Clinical Trials Regulation has been published by EMA and has come into effect throughout the European Union on 31 January 2022.

What can we expect with this new harmonised legislation?

  1. The Clinical Trials Information System (CTIS) will streamline the applications' submission through a single system.
  2. The Medical Ethics review across the EU adjustment.
  3. The clinical trials under the new regulation – 3 years transition period.
  4. Substantial Modifications – limited.

For further details, see EU Clinical Trials Regulation published on EMA website.

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