The American Food and Drug Administration (FDA) has recognised the FAMHP as its Belgian counterpart under the mutual recognition agreement (MRA) between the European Union and the United States.
Make medicines safer by reporting side effects in children or during pregnancy or breast feeding. The FAMHP again participates in an international campaign to emphasize the importance of reporting side effects.
The campaign will run from the 19th to the 23rd of November and is part of an awareness week of 32 drug authorities from the EU, South America, the Middle East and Australia.
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.
Give your opinion on two clinical trials with a genetically modified medicinal product for the treatment of spinal muscular atrophy
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.
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 European Medicines Agency (EMA) is conducting a review of the possible health effects in patients who may have taken certain lots of valsartan medicines containing an impurity called NDMA. This impurity was found in the active substance manufactured by Zhejiang Huahai Pharmaceuticals.
Request for information to the marketing authorisation holders for medicinal products for human use, in view of Brexit
The Federal Agency for Medicines and Health Products (FAMHP) wants to get a better view of all upcoming new MRPs (Mutual Recognition Procedures), DCPs (Decentralised Procedures) as well as of all RMS switches (Reference Member State) resulting from Brexit. Marketing authorisation holders are asked to provide the FAMHP with the necessary information as well as the information regarding the sites for which the UK is actually responsible.
Give your opinion on a clinical trial with genetically modified vaccines developed for the treatment of hepatitis B
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified hepatitis B vaccines from the company GlaxoSmithKline Biologicals. The purpose of this trial is to evaluate the safety, the immunogenicity and the efficacy of hepatitis B candidate vaccines in adult patients with chronic hepatitis B. The public consultation runs from 24 July 2018 to 23 August 2018 inclusive.
During its meeting of July 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.