Annual Report 2017
Database for clinical trials
New database for clinical trials in Belgium
News
The FAMHP is updating the guidance document to assist clinical trials sponsors as
part of the pilot project for clinical trials in Belgium.
Submission of dossiers and documents to the Research and Development Division (human use) of the FAMHP via the CESP is compulsory since 1 October 2018. Today, the FAMHP publishes version 1.2 of the guidance.
The battle against anti-microbial resistance (AMRI) is one of the greatest challenges for our society according to the World Health Organization. Diseases are transferred from humans to animals and vice versa, so actions must be taken for prevention and fighting AMR in both the human and veterinary sector, and even on the level of the environment. This is why the FAMHP, together with all of the authorities involved, are committed to an inter-sector strategy in the battle against AMR, according to the principle of “One World One Health”.
During its meeting of October 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.
During the Christmas holidays, the FAMHP will be closed from Monday 24 December 2018 until Tuesday 1 January 2019 included.
The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XI from 9 to 15 October 2018. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were carried out at the Zaventem and Bierset airports.
Public consultation: clinical trial on a genetically modified medicinal product against hemophilia B
Give your opinion on a clinical trial with a genetically modified medicinal product for the treatment of hemophilia B.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified medicinal product AMT-061 from the company uniQure biopharma B.V. The purpose of this trial is to demonstrate the efficacy of AMT-061 for the treatment of moderate to severe haemophilia B and to further describe its safety aspects. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.
The FPS Public Health and the FAMHP invite you to participate in the public consultation on two clinical trials with the genetically modified medicinal product AVXS-101 from the company AveXis, Inc. The purpose of the trials is to evaluate the safety, tolerability and efficacy of AVXS-101 for the treatment of spinal muscular atrophy. The public consultation runs from 17 October 2018 to 17 November 2018 inclusive.