Annual Report 2017
Database for clinical trials
New database for clinical trials in Belgium
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.
European medicines authorities have placed the Chinese company Zheijiang Huahai under increased supervision and the Indian company Aurobindo Pharma is no longer allowed to supply irbesartan to EU member states.
The European Medicines Agency (EMA) published the eighth ESVAC (European Surveillance of Veterinary Antimicrobial Consumption) report on the sale of antibacterials for veterinary use in 2016.
Until today, the good manufacturing practices (GMP) for medicinal products were only available in English. As of now, the GMP will be available in French and Dutch on the FAMHP website.
The FAMHP would like to remind consumers and patients about a recall by Reckitt Benckiser of Durex Natural Feeling Extra Lubricated condoms and Durex Real Feeling latex-free polyisoprene condoms. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.
The FAMHP would like to relay safety information concerning two types of ear thermometer to consumers and patients. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.
In 2017, the 460 employees of the FAMHP closed more than 8,000 applications for marketing authorisation for medicines, carried out no less than 2,200 inspections and investigations, analysed more than 10,000 reports of adverse effects, reactions and incidents, and answered more than 250 press questions.