Activity
Mission
The Clinical Trial College (CT College) ensures that the ethical assessment of both clinical trials on medicinal products for human use and clinical investigations with medical devices is carried out in Belgium:
- within the harmonised European approval process;
- with the required quality; and
- independently of the sponsor, the clinical trial or investigation site, the investigators involved and any other undue influence.
The safety of the participants in the clinical trials and investigations is essential in this regard.
Tasks & Competences
As described in the art. 9 §3 of the Belgian law of 7th May 2017 (see tab ‘legislation’), the mission of the CT-College is as follows:
- to guarantee the communication between the FAMHP[1] and the ethics committees (ECs) as single point of contact;
- to select the independent EC that will carry out the ethical assessment of the clinical trial and investigation dossiers submitted, and to follow up on these submission dossiers;
- to ensure a coherent application of the law by the ECs. The CT College can in this case advise the ECs;
- to formulate on its own initiative or at the request of the Minister, advice relating to the application of the regulation, the law and its implementing decrees;
- to ensure the coordination, harmonization, support and monitoring of the quality control conducted by the ECs. The CT-College can adopt recommendations to this effect;
- to give administrative support to the ECs during the evaluation of the dossiers;
- to send an annual report to the minister and the Parliament.
List of ethics committees recognised under the law of 7 May 2017:
Below, you will find a list containing all ethics committees that have obtained a recognition in accordance with the law of 7 May 2017. This list also specifies whether the recognition is valid for the evaluation for Phase I clinical trials. The first recognition of each ethics committee is valid for a period of two years. Every renewal of this recognition is valid for a period of four years. This is the maximum validity period as determined by law (Art.6 §4 of the Law concerning clinical trials with medicinal products for human use of 7 May 2017).
|
Name Ethics Committee |
Recognized for Clinical trials of Phase 1 |
Recognition valid until (date) |
|
/ |
01/04/2030 |
|
|
/ |
01/04/2030 |
|
|
Comité d'Ethique Hospitalo-Facultaire Universitaire de Liège |
X |
01/04/2028 |
|
/ |
01/04/2029 |
|
|
/ |
01/10/2029 |
|
|
X |
01/10/2028 |
|
|
CEHF "Comité d'Ethique Hospitalo-Facultaire" Saint-Luc - UCLouvain |
X |
01/04/2029 |
|
X |
01/10/2026 |
|
| Commissie Medische Ethiek UZ Brussel/VUB | / | 01/10/2027 |
| Ethisch Comité U(Z) Gent | X | 01/10/2027 |
|
X |
01/04/2029 |
|
| Commissie voor Medische Ethiek ZAS Middelheim, Cadix, Palfijn, Hoge Beuken, Joostens | X | 01/10/2027 |
| Commissie Medische Ethiek AZ Groeninge | / | 01/10/2027 |
| Comité d’Ethique Hospitalo-facultaire HUB | X | 01/04/2029 |
| Comité Medische Ethiek Ziekenhuis Oost Limburg | / | 01/10/2026 |
[1] Federal Agency for Medicines and Health Products
Organogram
The CT College is an independent body set up within the FPS for Public Health, Food Chain Safety and Environment (FPS HFCSE).
How are we organized?
- Our administrative staff has the following tasks:
- to follow up on the development of the European Portal
- to represent the CT-College at national and European meetings
- to follow up on the budget of the CT-College and the payment of the ethics committees
- quality management, by developing, implementing and following up on a quality system for the CT-College as well as for the recognized ethics committees;
- file management, by the assignment of the Ethics committees to and follow up of the ongoing assessment dossiers.
- On 18 May 2021 and 7 November 2023, the minister appointed a Board of the CT-College, consisting of:
- two experts in quality control systems;
- four doctors with experience in performing or evaluating clinical trials;
- four jurists.
|
Administrative Staff |
|
| Teamleader | Katelijne Anciaux (NL) |
| Coordinator College Board | Sébastien Vanhiesbecq (FR) |
| Operational responsible MDR/IVDR | Michelle Fonteyne (NL) |
| Operational responsible CTR | Sophie Fumire (FR) |
|
File managers |
Marlène Keck-Antoine (FR) Lisa Reyckers (NL) Jean Pirard (FR) Annelies Marin (NL) Julie Seronvalle (FR) Marine Gillain (FR) Myriam De Rudder (FR) Soetkin Theunynck (NL) |
|
Board |
|
|
Effective |
Substitute |
|
Physicians with experience in phase I clinical trials |
|
|
Lucas Van Bortel, President (NL) |
Rene Westhovens (NL) |
|
Didier Verhoeven (NL) |
Philip Debruyne (NL) |
|
Experts in Quality control systems |
|
| Hilde Nevens, Vice-president (NL) | Joline Goossens (NL) |
|
Jurists |
|
| Bruno Fonteyn (FR) | Gauthier Broze (FR) |
| An Vijverman (NL) | Amber Cockx (NL) |
Legislation
Links to European legislation:
- Clinical trial regulation 536/2014 (CTR)
- Medical device regulation 2017/745 (MDR)
- In Vitro Diagnostic Medical device regulation 2017/746 (IVDR)
Links to Belgian legislation:
- Clinical trials
- Law of 7 May 2017 – Law on clinical trials on medicinal products for human use
- Royal decree of 9 October 2017 – Royal decree implementing the law of 7 May 2017 on clinical trials on medicinal products for human use
- Royal decree of 3 November 2019 – Royal decree modifying the royal decree of 9 October 2017 implementing the law of 7 May 2017 on clinical trials on medicinal products for human use
- Medical devices
- In vitro diagnostic medical devices
Workgroups
- Working group CTR-MDR
Along with the administrative staff of the CT-College and with the FAMHP, a few members of fully recognized ethics committees recognized under the 2017 law contribute to the procedures for implementing the CTR,MDR and IVDR in Belgium.
- Information sessions for fully recognized ethics committees under the 2007 law
The administrative staff of the CT-College, in collaboration with the FAMHP, organises an information session four times a to keep them informed of the principles and recommendations of the CT-College, changes of procedures, new documents to be used (templates), the application of the legislation and the new guidelines.
More info
This presentation gives you more information on:
- the implementation of the CTR, MDR and IVDR in Belgium
You'll find this presentation via this link.
Contact
General mailbox: ct.college@health.fgov.be
Publications
In this tab, you’ll find documents that have been approved and endorsed by the College Board. They have been classified by type: advices, guidelines, brochures and annual reports. You’ll find the Informed Consent Forms in the “Forms” tab.
Any questions or remarks regarding one document can be addressed to this email : ct.college(at)health.fgov.be
Advices
Annual reports
|
Title |
Language | Publication date |
|---|---|---|
| Rapport annuel 2021-2022 | FR |
29/02/2024 |
| Jaarverslag 2021-2022 | NL | 29/02/2024 |
| Rapport annuel 2023 | FR | 21/03/2025 |
| Jaarverslag 2023 | NL | 21/03/2025 |
| Rapport annuel 2024 | FR | 17/12/2025 |
| Jaarverslag 2024 | NL | 17/12/2025 |
| Rapport annuel 2025 | FR | 07/09/2026 |
| Jaarverslag 2025 | NL | 07/09/2026 |
Brochures
| Title | Language | Publication date |
|---|---|---|
| Brochure d'information relative aux études cliniques interventionnelles sur des patients adultes | FR | 06/02/2020 |
|
Informatiebrochure voor interventionele studies met geneesmiddel bij volwassen patiënten |
NL | 06/02/2020 |
Guidelines
| Title and endorsement date by the College | Language | Target audience |
|---|---|---|
| Guidance on the compensation of clinical research participants (10/10/2025) | EN | Sponsors, Ethics committees |
| Guidance for sponsors on the use of electronic informed consent in interventional clinical trials in Belgium (v2. 20/05/2022) | EN | Sponsors |
| Recommendation paper on decentralised elements in clinical trials (14/12/2022) | EN | Sponsors |
Forms
You’ll find below three new templates of Informed Consent Form (ICF) which were approved by the Board of the Clinical Trial College on January 24, 2025.
By decision of the CT-College Board, the use of the templates will become mandatory for sponsors and applicants submitting new initial study applications as of August 1st 2025.
Forms
| Title | Language | Approval date |
|---|---|---|
| Model ICF for Interventional clinical trials with trial medicine in adult healthy volunteers | FR, NL, EN | 24/01/2025 |
| Model ICF for Clinical Investigation with a medical device in adult patients | FR, NL, EN | 24/01/2025 |
| Model ICF for Interventional clinical trials with IMP on adult patients | FR, NL, EN | 24/01/2025 |
| EN | 28/06/2019 | |
| FR, NL, EN | 21/09/2020 |
Events
Recommendation of EU on decentralised elements in clinical trials
In December 2022 the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the use of decentralised elements in clinical trials as an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
The EU recommendations include an overview of national provisions for specific decentralised clinical trial elements to be used in clinical trials. Their primary goals are safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected.
Evidently, the recommendations are expected to evolve as knowledge increases and experience is gained. In particular, the overview of national provisions will be updated on a continuous basis.
ACT EU
The joint initiative ACT EU is a collaboration between EC, HMA and EMA that seeks to transform how clinical trials are initiated, designed and run.
The initiative was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system.
ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU/EEA citizens expect. ACT EU features ten priority action areas that are the basis for the ACT EU 2022-2026 workplan.
The original publication of the above mentioned EU recommendations concerning decentralised elements in clinical trials is available for downloading on the Public Health website of the EC: ‘Recommendation paper on decentralised elements in clinical trials’.
For more information and the official press release, please visit the EMA website.