From 31 January 2025, only the Clinical Trials Regulation (EU) 536/2014 and its delegated acts will apply, as stipulated in Article 98 of the regulation. The FAMHP calls on sponsors to transfer clinical trials to Regulation 536/2014 as soon as possible.
Clinical trials that have not transitioned to the Clinical Trials Regulation (EU) 536/2014 (CTR) by 31 January 2025 and have not been approved in the Clinical Trials Information System (CTIS), will no longer be authorised and are in breach of the CTR and the Act of 7 May 2017 on clinical trials of medicinal products for human use.
Therefore, all trial activities must be stopped until an authorisation has been granted in CTIS. If not, sponsors could be subject to corrective measures and penalties by Member States, and may be held civilly and criminally liable. Due to its unauthorised nature, continuing the trial would, at the very least, violate Article 4 of the CTR. This means that severe sanctions such as fines or even imprisonment are possible.
It is the responsibility of the sponsor to have obtain an approved transition application in CTIS by 31 January 2025. To ensure timely handling/processing of your submission, and therefore to avoid violation of the CTR and the law of 7 May 2017, the following recommendations apply.
- The applicant should provide a timely transition application so that your application can be finalised on time. The recommended date was 16 October 2024, but since this date is in the past, it is strongly recommended to submit your transition application as soon as possible. Keep in mind that processing your request could take up to 37 days, therefore your trial could no longer be authorised if not approved in CTIS by 30 January 2025.
- Substantial modifications according to the Clinical Trials Directive (CTD) and the law of 7 May 2004 are still legally acceptable, however we strongly recommend to prioritise the timely transition and to introduce your changes as substantial modifications according to CTR/law of 7 May 2017 afterwards.
To ensure an overview of the remaining trials that need to be transitioned, please send an e-mail to ct.rd@fagg-afmps.be with subject ‘TRANSITION_BELGIUM’. Please include the following information.
- The anticipated date of submission of the transition application in CTIS.
- If you are no longer a contact point for this trial, please let us know. If possible, also provide us the current contact point of this trial (sponsor/applicant).
- If you are aware of a foreseen end-of-trial (EOT) notification of this trial before 30 January 2025, please let us know.
- If this clinical trial has already ended, prematurely ended or never started in Belgium, please provide a duly completed end of trial notification form. Please inform us as well if the ethics committee never provided a favorable opinion.
This follow-up is crucial to ensure the lawful conduct of clinical research and thus the safety of participants and the quality of research data.
More information on transitioning a study from CTD to CTR:
- Guidance for transition of clinical trials from CTD to CTR published by the European Commission
- CTCG Best Practice guide for sponsors on transition trials
- CTCG Template annex cover letter for transition trials
- A summary of available information on transition trials on the website of the FAMHP
Questions about or problems with the transition application?
ct.rd@fagg-afmps.be