Directive 2001/20/EC and Development Safety Update Reports

Clinical trial applications (CTAs)

CTAs according to Directive 2001/20/EC
Dossiers for initial clinical trial applications (CTAs) submitted according to the directive 2001/20/EC can be submitted until 31 January 2023. The submission of substantial amendments (SAs) will be accepted until the end of the trial or until the transition of the trial from the Directive 2001/20/EC to the Clinical Trial Regulation (CTR) EU 536/2014, both at the latest by 31 January 2025.

Transition to the CTR
All clinical trials still ongoing after 31 January 2025 must be transitioned to the CTR. The transition dossier must be submitted at the latest sixty days before the end of the transition period (CTIS). A specific module on how to transition a trial from the Directive 2001/20/EC to the CTR will be published in January 2022 by the European Medicines Agency (EMA).

Submitting a clinical trial application
Each clinical trial protocol is identified at European level with a unique number. This number should be requested by the sponsor/applicant in the EudraCT database before submitting any CTA. The European application form, which is part of the dossier, also has to be completed in the EudraCT database.

A clinical trial can only start after receiving a favourable opinion from a recognised Ethics Committee and if the relevant authority, the Research and Development Division (human use) of the FAMHP, has not indicated any major deficiency within the legal timeframe as stipulated in the law of 7 May 2004 on experiments on humans (French version).

An application to the FAMHP must contain a full electronic file. Please consult the following documents for more information.
•    Guidance for submission of dossier
•    Detailed guidance on the request of a clinical trial to the competent authorities

The application to the FAMHP must be sent via the Common European Submission Portal (CESP) to:

Federal Agency for Medicines and Health Products
Research and Development Division (human use) 
Galileelaan - Avenue Galilée 5/03

We advise you to contact us if no confirmation of receipt has been received within five working days after submission of CTA dossiers and/or SMs via CESP.

Submission of CTAs with genetically modified organisms (GMOs) in medicines
Follow the instructions in the Belgian Regulatory Guidance on the Use of Genetically Modified Organisms in a Clinical Trial for the submission of applications for CTAs with GMOs in medicines.

A questions and answers document and an overview of the regulatory requirements in EU countries are available on the European Commission website.

Development Safety Update Reports (DSURs)

Important message for clinical trial sponsors on suspected unexpected serious adverse reactions (SUSARs) and the use of new functionalities of the Eudravigilance reporting tool EVWEB

Once a year and during the entire duration of the trial, the sponsor must provide the FAMHP and the Ethics Committee a list of all suspected SUSARs that have occurred during that period. The sponsor should also provide a report on the safety of the participants pursuant to article 28, § 2 of the law of 7 May 2004 on experiments on humans (French version) on experiments on humans.

The following documents should be submitted to the FAMHP via the CESP.
•    The DSUR that complies with the format mentioned in the International Conference Harmonisation guideline
•    The template DSUR – submission for Belgium
•    A signed cover letter

A guidance document for submission of DSURs to the Research and Development Division (human use) is available on the FAMHP website.

The sponsor has to pay a fee for each submitted DSUR.
The FAMHP asks that payment be made based on the structured invoice. More information on the payment method and the fee amount is available on the FAMHP-website.

Legal framework
European Directive 2001/20/EC has been incorporated into national law by the law of 7 May 2004 on experiments on humans (French version) published in the Belgian Official Journal of 18 May 2004. This legal framework has been in force since 1 May 2004.

The law of 7 May 2004 has been amended several times (see below).

•    Law of 7 May 2004 on experiments on humans (French version), amended by the following laws
   o    Programme law of 27 December 2004 (French version)
   o    Programme law dated 27 December 2005 (French version)
   o    Health law of 13 December 2006 (French version)
   o    Programme law of 13 December 2006 (French version)
   o    Programme law of 27 April 2007 (French version)
   o    Law of 24 July 2008 on various dispositions (French version)
   o    Law of 19 December 2008 on various health dispositions (French version)

Royal Decrees
•    Royal Decree of 30 June 2004 (French version) determining the measures for implementing the law of 7 May 2004 on experiments on humans (French version) within the framework of clinical trials of medicines for human use, modified by the Royal Decree of 18 May 2006 (French version).
•    Royal Decree of 15 July 2004 (French version) determining the fees to be paid for a request for an opinion or for authorisation to conduct a clinical trial or an experiment.

•    Circular 575 on clinical trials submission has been replaced by the guidance for the submission of a dossier.
•    Circular 586 (French version) on the national implementation of the detailed guidance CT-3. Please note the email address is no longer available. Questions related to reporting via the EudraVigilance system should be sent to instead.
•    Circular 596 (French version) on production and distribution activities for experimental medicines and additional information to point 9 in the annex - point 9 ("extemporaneous preparations") (French version)
•    Circular 639 (French version) on changes to the law of 7 May 7 2004 concerning experiments on humans.
•    Circular 653 (French version)on clinical trial requests related to COVID-19.

European directives
•    Directive 2001/20/EC of the European Parliament and of the Council.
•    Directive 2005/28/EC of the Commission laying down principles and detailed guidelines for good clinical practice.
•    Directive 2003/94/EC of the Commission laying down principles and detailed guidelines for good manufacturing practice.

Orientation documents
•    Eudralex – Volume 10 – Clinical trial guidelines
•    Guidelines of the clinical trials facilitation and coordination group – Heads of Medicines Agencies

Research & Development

Last updated on 21/11/2023