Draft circular concerning the request for authorisation of a clinical trial: call for comments

A new version of the document "Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (“CT-1 ")" was published on 30th March 2010. A draft circular giving instructions resulting from the transposition of this guidance in Belgium is submitted to the concerned partners for comments.

The new version of the document “Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)” contains a number of important changes including the introduction of electronic application for authorisation to conduct clinical trials and the substantial amendments.

Therefore, the FAMHP organised a workshop in June with a number of partners. It now gives the possibility to all interested persons to critically evaluate and comment on the draft version (French, Dutch and English version) of the circular that will apply in future.

Comments may be submitted until 23rd October 2010, either by e-mail to ct.rd@fagg-afmps.be  or by post to the following address:

Federal Agency for Medicines and Health Products
Research and Development Division
For the attention of Kristof Bonnarens
Eurostation II
Victor Hortaplein 40/40
1060 Brussel

Last updated on 25/01/2013