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EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation

The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across the European Union (EU) to ensure patient safety and foster innovation. On 19 July, 2023 EC released an updated guidance "Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation".

After a clinical trial's transition from the CTD, MS reduces the assessment to meet the minimum requirements for compliance with the CTR rules (such as transparency).

Clinical trial sponsors should register their trials under CTIS as early as possible in order to facilitate that process, taking into account the time needed for the applications to be approved.

The guidance contains a list of questions and answers that provide information on the type of clinical trials that sponsors have to transfer to CTIS, the timeline, and the content of the application for mono- and multinational trials.

An application for a clinical trial to transition to the CTR must be submitted as part of a transitioning application. The transitioning application will reflect the application that has already been approved by an ethics committee and authorised by an NCA.

Only clinical trials authorised under the CTD with at least one active site in the EU on 30 January 2025 need to be transitioned. The transition of clinical trials from the CTD to the CTR is open to sponsors:

  • from the day of the entry into application of the Regulation, on 31 January 2022

  • until the end of the 3-year transitional period, on 30 January 2025, without the need to discontinue a clinical trial or put a trial on hold.

It is the sponsor's responsibility to make public the documents submitted in the transitioning application in accordance with the CTR transparency requirements.

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