Transfer of clinical trials from CTD to CTR
As of 31 January 2023, all clinical trial approvals must be granted in accordance with Regulation (EU) No. 536/2014 – the Clinical Trials Regulation (CTR). One of the stipulations of the CTR is that clinical trials that were approved under the old legislation, the Clinical Trials Directive (CTD), may only continue under the CTD until 30 January 2025. After this date, these clinical trials may only continue pursuant to Article 98 of Regulation (EU) No. 536/2014 after having been transferred to the new legal framework.
The transfer of clinical trials – from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) – is available to sponsors until the end of the three-year transition period on 30 January 2025. There is no need to cancel or suspend a clinical trial during the transfer process. The transferred clinical trial must be approved by the deadline. Once the deadline has passed, according to the CTR, an ongoing clinical trial can only continue after an application for a new clinical trial is submitted.
If a clinical trial is ongoing and will continue beyond 30 January 2025, planning for the transition must be initiated in a timely manner so that the clinical trial will be compliant with the law after 30 January 2025.
In order to ensure a smooth transition, the Paul-Ehrlich-Institut expressly asks sponsors to submit their transition applications as early as possible and not shortly before the deadline.
Sponsors must be sure to consider the time required to complete the approval process in accordance with Chapter 2 of the CTR and the European Commission Directive. Sponsors are therefore strongly advised to submit their applications before 30 January 2025, taking into account the time needed for evaluation, which may extend from one week (accelerated procedure) to up to 106 days if a complete study application is required. Please also note the winter clock stop (from 22 December 2024 to 6 January 2025).
The end of the clinical trial is considered to be the end according to the study protocol (= end of the conduct of the trial).
An extension of the transitional period for clinical trials is not possible.
Updated: 31.01.2024
