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The new law on clinical trials has been published in the Belgian Official Gazette (Moniteur belge/Belgisch Staatsblad) on 22 May 2017. Following this occasion, the Federal Agency for Medicines and Health Products (FAMHP) will organise a symposium on clinical trials on 26 September 2017 in Brussels.

Following the success of the first session of the recast symposium, the FAMHP organises, as the competent authority, on Tuesday 13th June 2017 a second session of this symposium over the latest official information about the recast.

The VACCINES spearhead from the FAMHP organises a symposium on vaccinology on Saturday 9 th September 2017 at the Hotel Pullman (Brussels). 

As previously reported, the FAMHP has started a pilot for clinical trials in Belgium in collaboration with the new college charged with designation the ethics committee for the evaluation of clinical trials, the current ethics committees and sponsors of clinical trials.

All tissue establishments in Europe, including the ones located in Belgium, can from now on be found through a new compendium.

As from the  7th of February, new version of the electronic application form are available. For more details please go to the esubmission webpage of EMA.

The Federal Agency for Medicines and Health Products was created in 2007. In 2017 we celebrate our ten year anniversary.

In October 2018 the new clinical trial regulation 536/2014 (CTR) is foreseen to enter into force. This important change in legislation targets administrative simplification and harmonization in Europe.

The Heads of Medicines Agencies (HMA) has published a statement of intent related to the replacement of the eAFs by the CESSP. As outlined in the eSubmission Roadmap, the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway will be integrated into a Single Submission

During the Christmas holidays, famhp will be closed from Monday 26 December 2016 until Friday 30 December 2016 included.