All ongoing clinical trials in the EU must have transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. The FAMHP is hosting a webinar for all stakeholders on 13 June 2024.
31 January 2025 marks the end of a three-year transition period for ongoing clinical trials that started when the Clinical Trial Regulation 536/2014 (CTR) came into effect in the EU.
Sponsors of clinical trials initiated according to the old legislation and expected to continue after 30 January 2025, should take into account the time required by the FAMHP to complete the authorisation process, which can take up to three months. The FAMHP therefore recommends that applications be submitted no later than 16 October 2024. Additionally, if applicable, when submitting a final substantial amendment according to the old legislation (law of 7 May 2004 on experiments on human beings) to enable transition to CTR, sponsors are asked to clearly state this in the first section of the cover letter.
With this timely transition to CTR, ongoing clinical trials will not have to be stopped or terminated during the transition from the previous legal framework, meaning the law of 7 May 2004, to the Clinical Trials Regulation (CTR).
Webinar
The Federal Agency for Medicines and Health Products (FAMHP) invites all stakeholders to a webinar on the transition of clinical trials from the law of 7 May 2004 to CTR. This event is scheduled on 13 June 2024, from 10:30 a.m. to noon. English will be the only language of communication.
To register, send an email before 27 May 2024 to ct.rd@fagg-afmps.be with the following subject line: "Webinar transition trials."
Those who signed up for the webinar will have the opportunity to submit their questions in advance. The link will be sent by email at the end of May and will close one week prior to the event.
During the webinar, participants will be given ample opportunity to ask additional questions and clarifications. Keep in mind that the information will be provided orally.
The webinar will be recorded, and the recording will be made available at a later date.
More information
FAMHP website: European Regulation 536/2014 (CTR) and CTIS
EMA website: Clinical Trials, Guidance and Q&As
CTIS training for non-commercial sponsors transferring clinical trials to CTR.