Ongoing clinical trials under the Directive

As of January 31, 2023, clinical trials can no longer be applied for under EU Directive 2001/20/EC. Instead, please refer to the EU Regulation for clinical trials on medicinal products. Read more here: Transition (from Directive to Regulation) and guidance in EudraLex Vol 10 for the Regulation

If an ongoing trial is not completed 3 years after the regulation has entered into force, the trial must be transferred to the regulation. This means that trials not completed by January 31, 2025 must be transferred to the regulation. If the trial is not transferred before then, it must be stopped, otherwise it will be conducted illegally.

Until the trial is transferred to the regulation, amendments, annual safety reports, termination of trials etc. must be submitted under the current legislation for the directive.