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The FAMHP is organising two information sessions for sponsors on the new clinical trials regulations (CTR):
•    on 10 March 2023;
•    on 13 March 2023 (in the morning).

Register before 15 February 2023 by sending an e-mail to CTR@fagg-afmps.be with the following subject: “registration CTR info session 2023”.
 

News

Important for clinical trials sponsors: mandatory use of E-Submission Food Chain platform for clinical trials with genetically modified medicinal products

Since 1 October 2022, all Summary Notification Information Format documents submitted with applications for clinical trials with medicinal products, entirely or partly composed of genetically modified organisms covered by Directive 2001/18/EC for deliberate release, must be submitted through the E-Submission Food Chain platform.

New Clinical Trial Regulation: new transition phase, possible delays in the processing of substantial modifications, and information sessions for sponsors

The new Clinical Trial Regulation 536/2014 (CTR) entered into force on 31 January 2022. This new regulation on clinical trials applications of medicines for human use aims to simplify administration and harmonise legislation within the European Union. On 31 January 2023, a new transition phase will start and from then on all initial clinical trial applications have to be submitted via CTIS. The FAMHP is organising two information sessions on the clinical trials regulation.