Clinical Trials: EMA clarifies Dates for the Transition Period

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised Version 3.01 has now been published. Following the previous update on how to manage clinical trials transitioned to the CTR (Version 3.00), the EMA now clarifies the timelines for the transition period.

Transition Period Timelines

There is a 3-year transition period that started on the CTIS go-live date:

• Year 1 (31 January 2022 to 30 January 2023):
  During the first year after CTIS go-live, sponsors may choose whether to apply for a new Clinical Trials Application (CTA) under the Clinical Trial Directive (CTD), or to apply under the new legislation, the Clinical Trial Regulation (CTR), using the Clinical Trials Information System (CTIS). Both options are possible, and sponsors are able to choose which legislation to follow.
• Years 2 and 3 (31 January 2023 to 30 January 2025):
  From 31 January 2023, all new CTAs must be submitted under the new legislation (CTR) using CTIS. Submission of new CTAs under the CTD in EudraCT will not be available for new CTAs. The addition of new member states (MS) will no longer be possible under the CTD as from 31 January 2023. Trials under the CTD must first be transitioned, and then an Additional MS Concerned Application can be submitted using CTIS.

What are the Assessment Timelines?

Only trials submitted under the CTD and likely to be ongoing beyond 30 January 2025 need to be transitioned if they meet certain criteria (see "How to manage clinical trials transitioned to the CTR"). In CTIS after submission of the dossier, the assessment workflow is triggered and the MSC (Member States Concerned) need to select the RMS (Reference Member State) in the event of multi-national trials. Transitioning a trial from the CTD to the CTR can take up to a period of 60 days. In case, the documentation submitted does not correspond with the documents approved under the CTD the timelines would be extended by 15 days in the validation or 31 days in the assessment phase.

More information can be found in the Clinical Trial Information System (CTIS) - Sponsor Handbook (v. 3.01) on the EMA CTIS website.