Clinical trials for human medicines
Submitting an aplication
A clinical trial can only start after receiving a favourable opinion from the Ethics Committee ( recognized Ethics committees (XLS, 125.5 Kb) ) and if the relevant authority (AFMPS: R&D) has not indicated any major insufficiency within the legal timeframe.
An application for the FAMHP, is a full paper file which contains the following electronic data: XML; protocol; IMPD and IB. The application must be sent to the attention of:
Devision R&D
Federal Agency for Medicines and Healthproducts
Recherche and development department
Eurostation II
8th floor
Place Victor Horta 40, 40
1060 BRUSSELS
Each submitted file must be accompanied by payment of a fee. Each complete file requires payment of € 3360,06 and each modification requires payment of € 300,24. Payment must be made on the following account : 679-0001514-59
Contact details of the bank :
Poste financière
Chaussée d'Anvers 59
B-1100, Bruxelles (Belgium)
SWIFT code: PCHQBEBB
IBAN code: BE84 6790 0015 1459
For payments from abroad the transfer fees are paid by the payer. It is not necessary to attach proof of payment to the request since this is checked by looking at the bank statement.
Please mention "EudraCT" on the bank statement followed by the EudraCT number. This is also the procedure for any modification – please also mention 'amendement'.
For each file and / or modification a separate payment should be made.
The validation phase only begins when the R&D department has received the file and the proof of payment from the bank.
The maximum time taken by AFMPS to give an opinion is 15 days for monocentric phase I clinical trials and 28 days for all other clinical trials.
For formulating a CTA you will find all the details in the following document : " Detailed guidance for the request for authorisation of a CT on a medicinal product for human use : "CT Application (PDF, 878.07 Kb) ". For Belgium only one copy of each document is required.
The only document not listed in the table is the declaration form. If any stage in the manufacture, storage or distribution of an Investigational Medicinal Product (IMP) takes place in Belgium this IMP has to be submitted by means of a declaration form. Each company responsible for one of these operations, must complete a new declaration form.
The requesting company must also seek a European number from the EUDRACT database of the EU. On this site the XML file must be created and the EU request form must be downloaded :
Special requirements:
In view of the particular nature of the production method, it is possible to grant a "conditional approval" for the annual update of flue vaccines that have already been authorised.
This means that such a trial can be approved even if some data about the quality (in particular certificates of analysis) are missing. But that is only valid if these data are submitted to AFMPS one week before the start of the clinical trial and if the evaluation is positive.
Legal texts
The European directive 2001/20 has been incorporated in national law by the law dated 7th May 2004 (French version)
published in the Belgian Monitor of 18th May 2004. The new legal framework has been in force since 1st May 2004.
After the programme law dated 27th December 2004 (French version) and 27 December 2005 (French version) concerning the changes to the law of 7/05/04 (French version), the law of 13/12/06 (French version) published on 22/12/2006 contains different definitions concerning health.
Note: the laws, royal decrees and circulars are (except for a few) not translated in English. Therefore we refer to the links on the French and the Dutch version of the website.
Laws
Law dated 7th May 2004 (French version) related to experiments on human people.
Law of May 7th 2004 (DOC, 126.5 Kb) : unofficial consolidated version. This is an English translation and can not be considered as legal.
Programme law dated 27/12/04 (French version) modifying the law dated 7/05/04 (French version)
Programme law dated 27/12/05 (French version)
Health law dated 13th December 2006 (French version)
Programme law dated 13th December 2006
Programme law dated 27th April 2007 (French version)
Royal Decrees (laws)
Royal Decree dated 22th April 2007 fixing the fees to be paid in the framework of article 30, § 6 of the law dated7th May2004 (French version) relating to experiments on human people.
Royal Decree dated 30th June 2004 (French version) determining the measures for carrying out the law dated 7th May 2004 (French version) relating to the experiments on human people concerning clinical trials of medicines for human use, modified by the
Royal Decree dated 18th May 2006 (French version)
Royal Decree dated 15th 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.
Royal Decree dated 14th December 2006 (French version) (part 1 - part 2) concerning medicines for human or veterinary use, which replaces the Royal Decree of 6/6/60 (French version).
Circulars
Circular 585 (PDF, 1.11 MB) (04/04/2012) (French version): List of Ethics Committees having full approval according to the law dated 7th May 2004 related to experiments on human people.
Circular 584 (PDF, 947.79 Kb) (14/02/2012) (French version) + annex (DOC, 204.5 Kb): Pending payments for ethics committees (2009).
Circular 583 (PDF, 407.64 Kb) (French version): Fees for applications of clinical trials.
Circular 575 + annexes (PDF, 1.1 MB): Application for clinical trials and submissions of substantial amendments.
Circular 573 (French version) (PDF, 399.51 Kb): Pending payments for ethics committees.
Circular 564 (French version) (PDF, 159.17 Kb): Fees for applications of clinical trials.
Circular 515 (French version) (PDF, 804.27 Kb): changes to the list of the Ethics Committees having full approval.
Circular 512 (French version) (PDF, 1.42 MB): pending payments for the Ethics Commissions - Indexation of the amounts for experiments - data for the interactive website – 2007 activity reports.
Circular 504 (French version) (PDF, 80.55 Kb): indexation of payments for the application for clinical trials.
Note : the amounts to be paid are rounded figures
Circular 493 (French version) (PDF, 1.19 MB): additional payment of € 850, clarifying the changes and some important points when submitting a file for approving a clinical trial, update circular 447 (French version) (DOC, 90.5 Kb).
Circular 493 (DOC, 476.5 Kb) : This document is a summary of the official and signed version in Dutch and French.
Circular 480 (French version) (PDF, 420.41 Kb) for sponsors and CRO's: some clarifications of circular 472 (French version) (PDF, 122.55 Kb).
Circular 472 (French version) (PDF, 122.55 Kb): for directors of hospitals and presidents of Ethics Committees : application of the law dated 7th May 2004 (French version) concerning experiments on human people : some clarifications for Ethics Committees and medical management.
Appendix 1 (French version) (PDF, 76.15 Kb): additional information and the list of ethics committees with full or partial recognition.
Details of the ethics committees with full recognition (XLS, 125.5 Kb)
Appendix 2 (French version) (PDF, 13.72 Kb): the declaration of conflicts of interest.
Financial results : this report is submitted for approval to the consultative Bioethics Committee and to the department of Budget and Management Control at AFMPS at the latest in May each year.
(Article 6, law dated 15/07/2004 (French version) )
Circular 461 (French version) (PDF, 19.93 Kb): clarifications about the lack of proof of payment or absence of the file.
Circular 460 (French version) (PDF, 1.61 MB): quick notification (in 7 / 14 days) of individual reports about serious adverse reactions relating to registered or unregistered medicines to the Directorate-General of Medicines and to the main Ethics Committees.
The history of previous circulars is as follows :
Circular 447 (French version) (DOC, 90.5 Kb): explanations about submitting an application for an opinion or for authorisation to conduct a clinical trial.
Circular 455 (French version) (PDF, 33.46 Kb): explanatory text relating to the law dated 7th May 2004 (French version) concerning experiments on human persons.
Appendix 1 circ. 455 (French version) (DOC, 62.5 Kb): FAQ (French version)
Appendix 2 circ. 455 (French version) (DOC, 85 Kb): circular about volonteers participating in a phase I trial
Appendix 3 circ. 455 (French version) (XLS, 54 Kb): financial report of the local Ethics Committee (CEL in French) for 2004
Appendix 4 circ. 455 (French version) (DOC, 25 Kb): explanations about the 2004 financial report of the local Ethics Committee (CEL)
Directives
Directive 2001/20/EC (PDF, 151.71 Kb) of the European Parliament and of the Council
Directive 2005/28/EC (PDF, 66.21 Kb) of the Commission laying down principles and detailed guidelines for good clinical practice.
Directive 2003/94/EC (PDF, 114.97 Kb) of the Commission laying down principles and detailed guidelines for good manufacturing practice.
Orientation documents
Exploratory clinical trial: guidance (PDF, 148.4 Kb) (version 2 - January 2012)
Eudralex Volume 10: http://ec.europe.eu/enterprise/pharmaceuticals/eudralex/homev10.htm
In particular you will find the following documents in this volume :
- EudraCt (PDF, 231.22 Kb) - Detailed guidance on the European clinical trials database
- EudraVigilance Clinical Trial Module (PDF, 115.66 Kb) - Detailed guidance on the European Database of Suspected Unexpected Serious Adverse Reactions
- CT Application (PDF, 293.7 Kb) - Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use
- Ethics Committees Application (PDF, 134.39 Kb) - Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion
- Adverse reaction reporting (PDF, 86.72 Kb) - Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials
Guidance on IMP’s and other medicinal products used in Clinical Trials (PDF, 41.39 Kb)
Symposia
- Belgian pharmaceutical conference - 17/04/2012
One of the main sessions during the Belgian Pharmaceutical Conference (Terhulpen, 17th of April 2012) covered clinical research in Belgium. An important topic, because clinical research is more then just a way to gather evidence for future medicinal products : it is also an important job creator (almost 30.000 jobs in Belgium). For patients, the participation to clinical trials can mean an early access to innovative medicines. Belgium is one of the bigger research countries in Europe : 9% of the clinical trials in Europe are performed in Belgium.
The current situation on clinical trials has been investigated by Ingrid Maes, Director Strategy & Operations Pharma & Healthcare of PwC. The FAMHP’s database on clinical trials was investigated, and a survey was held with representatives of various stakeholders.
The results of this investigation were presented – the presentation can be downloaded HERE (PDF, 945.47 Kb).
- "Clinical trials: from European perspective to National implmentation - 19/11/2010
The symposium "Clinical trials: from European perspective to National Implementation" took place on November 19th 2010 and was organised by the European Clinical Trials Facilitation Group (CTFG), the Belgian Federal Agency for Medicinal and Health Products (FAMHP) and pharma.be, the federation of the Belgian Pharma industry. The importance of clinical research for Belgium is multiple: not only does the conduct of clinical trials deliver a substantial contribution to the economy in the form of investments and jobs, but clinical trials are also a driver for the financing of scientific and academic research. Both are important drivers in a knowledge economy, that contribute to innovation and to the development of better medicines for mankind.
Presentations of the national and international speakers during the event:
1. Introduction from an industry and an NCA point of view
- G. Musch (FAMHP): "Introduction"
2. Feedback on topics from first day, reactions from industry and EC and proposals on how to proceed especially for (N)IMP issue
- C. Bélorgey (CTFG): "Feedback on topics from first day"
- E. Godfrey (MHRA) : "IMPs/NIMPs - Background therapy in Oncology Trials"
3."One-stop-shop"
- S. Führing (EC): "One-stop-shop"
- Point of view Industry: L. Uylenbroeck (HST): "Clinical trials in Europe and in particular in Belgium: the "one-stop-shop" as a necessary condition for continuity, survival or growth?"
4. Non-Interventional trials: Need for a regulatory framework?
- G. Musch (FAMHP) : "Introduction"
- M.A. Serrano (AEMPS) : "Spanish regulation and experience regarding non-interventional post-authorisation studies (NIS)"
- C.-L. Julou (EFPIA): "Various considerations"
- M. Podoor (pharma.be) : "Industry view"
- F. Meunier (EORTC) : "The Academic point of view"
5. Safety in clinical trials : from detection to decision (how safety events are captured and treated by promoters and NCA's)
- E. Stahl (BFARM): "CTFG -NCA's view"
- S. Luik (EFPIA): "Safety Reporting in Clinical Development - Points to consider"
- N. Dubois (EORTC): "Experience of an academic sponsor regarding the safety reporting process for clinical trials"
The presentations can be downloaded as a zip file : Presentations CTFG 19 november
(ZIP, 3.18 MB)
Contact
Federal Agency for Medicines and Healthproducts Recherche and development department
Eurostation II
8th floor Place Victor Horta 40, 40
1060 BRUSSELS