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:
The safety of the participants in the clinical trials and investigations is essential in this regard.
As described in the Belgian legislation (see tab 'legislation'), the mission of the CT-College is as follows:
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)
Commissie medische ethiek AZ Delta
/
01/04/2026
Commissie voor Ethiek van het AZ Sint-Jan Brugge-Oostende AV
Comité d'éthique hospitalo-facultaire universitaire de Liège
X
01/04/2025
Comité d'Ethique hospitalier CHU UCL Namur, site Godinne
Comité d'Ethique Hospitalo-Facultaire Erasme-ULB
01/10/2025
Comité d'Éthique de l’Institut Jules Bordet
Ethische Toetsingscommissie Jessa Ziekenhuis
Ethisch Comité van het Onze-Lieve-Vrouwziekenhuis (Aalst-Asse-Ninove)
01/10/2024
Comité d'Ethique Hospitalo-Facultaire Saint-Luc - UCLouvain
Ethisch Comité UZA/UAntwerpen
01/10/2026
Ethische commissie onderzoek UZ/KULeuven
[1] Federal Agency for Medicines and Health Products
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?
Administrative Staff
File managers
Marlène Keck-Antoine (FR)
Lisa Reyckers (NL)
Jean Pirard (FR)
Annelies Marin (NL)
Bram Ottenbourgs (NL)
Julie Seronvalle (FR)
Marine Gillain (FR)
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
Jurists
Links to European legislation:
Links to Belgian legislation:
To prepare the implementation of the CTR[1] in Belgium, a number of clinical trial applications have been submitted by sponsors to the FAMHP as pilot projects since May 2017. The procedure to approve clinical trials complies with the national legislation of 7 May 2004, but the application dossier as well as the assessment follow the spirit of the new European Regulation and the Belgian law of 7 May 2017.
The CTR pilot project for initial dossiers has now ended and the last initial dossiers were submitted in October 2021. For trials approved under the CTR pilot project, substantial modifications will continue to be treated according to this procedure until 31 January 2025.
The administrative staff of the CT-College works during our pilot projects according to the tasks and competences described. You will find more information about this pilot project on the FAMHP’s website.
Along with the administrative staff of the CT-College and with the FAMHP, a few members of fully recognized ethics committees contribute to the procedures for implementing the CTR and MDR in Belgium.
Along with the administrative staff of the CT-College and with BAREC[2], a few members of fully recognized ethics committees, representatives of patient organisations and Pharma.be[3] contribute to the revision of templates for the Informed Consent Form.
Along with the administrative staff of the CT-College and with BAREC, a few members of fully recognized ethics committees, representatives of Pharma.be, BeCRO[4] and BAPU[5] contribute to the creation of a template for an Informed Consent Form for clinical trials in healthy volunteers.
In order to develop a separate template for vaccine trials in healthy volunteers, the working group has been expanded to include representatives of the Belgian vaccine centers.
The administrative staff of the CT-College, in collaboration with the FAMHP, organises three times a year an information session for the ethics committees recognized under the law of 2017 to inform them about the progress of the aforementioned initiatives.
[1]Clinical Trial Regulation
[2]Belgian Association of Research Ethics Committees
[3]The umbrella organization for the Belgian pharmaceutical industry
[4]Belgian association of Clinical Research Organizations
[5]Belgian association of Phase I units
This presentation gives you more information on how the CTR, MDR, and IVDR have an impact on :
Implementation of the CTR, MDR, and IVDR in Belgium
General mailbox: ct.college@health.fgov.be
Title
Language
Publication date
Recommendation paper on decentralised elements in clinical trials
Advice for Belgian ECs regarding the assessment of safety reports in CTR applications
Guidance for sponsors on the use of electronic informed consent in interventional clinical trials in Belgium
30/09/2020
v2.0 29/06/2022
Information brochure for interventional trials with medicinal products for adult patients
NL
19/03/2020
Model ICF for interventional clinical trials with IMP on adult patients
EN
28/06/2019
Example – The trial at a glance
Information for ethics committees and sponsors on the informed consent procedure in trials ongoing at or completed before 25th may 2018 (pdf)
05/12/2018
ANNEX to the “Information for ethics committees and sponsors on the informed consent procedure in trials ongoing at or completed before 25th May 2018” (docx)
Implementation of the CTR, MDR, and IVDR in Belgium (pdf)
12/06/2018
v2. 11/04/2023
The CT College Board clarifies the role of the Ethics Committees (ECs) in evaluating clinical trial safety reports submitted under the European CTR.
According to...
This information brochure contains an overview of the general (non-study-specific) information that is present in every informed consent form (ICF) that is presented to adult patients who wish to...
This document contains FAQs on the IC procedure in trials ongoing at or completed before the implementation of the GDPR.
A link to the English version of the annex has been added on 04/...
A new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated working group. This working group consisted of representatives of BAREC (Belgian Association of Research Ethics Committees), pharma.be (the Belgian association of the innovative (bio)pharmaceutical industry) and patient organizations, and was coordinated by the CT-College at the FPS Health Food chain safety and Environment. During the review process of the proposed template the feedback on the content and format was also provided by laypersons.
Sponsors are highly recommended to use the template, when preparing the ICF(s) for all new initial interventional clinical trials on adult patients. During the next six months a transitional period will be in place during which both the old and the new template can be used. From 1st January 2020, the ethics committees will require that only the new template is used by all sponsors.
Questions on the use of this template may be sent to ct.college@health.fgov.be”. Please mention “ICF_Template” in the subject of your mail.
This new template for the Informed Consent Form (ICF) for interventional clinical trials with an investigational medicinal product on adult patients was prepared by a dedicated working group. This...
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.
Information session for fully recognized ethics committees taking part in the pilot project:
