News FAMHP

De FOD VVVL en het FAGG nodigen u uit om deel te nemen aan de publieksraadpleging over een klinische proef met het genetisch gewijzigde geneesmiddel AG013 van de firma Oragenics. De proef dient om de veiligheid en werkzaamheid te beoordelen van AG013 voor de onderdrukking van orale mucositis bij patiënten met kanker van het hoofd en de hals die gelijktijdig radio- en chemotherapie krijgen. De publieksraadpleging loopt van 18 juni 2018 tot en met 18 juli 2018.

The company Bayer Pharma AG has decided to permanently withdraw the ESSURE ESS 305 sterilisation device from the market in the European Union, as of 30.05.2017. The manufacturer confirms that women already implanted with this device may continue to use it and that its preventative removal is not necessary for women who are not presenting any symptoms.

The telephone accessibility of the Call centre Marketing Authorisation of the FAMHP will change as from 1 June 2018. The Call centre Marketing Authorisation will answer your call between 9 AM and 1 PM.

During its meeting of May 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has confirmed its recommendation to suspend hydroxyethyl-starch (HES) solutions for infusion, has recommended new measures for Esmya, has finalised the review of Zinbryta and has issued precautionary advice on HIV medicine.

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

The FAMHP informs you about the new guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the R&D (human) Division of the FAMHP.

The FPS Health and the FAMHP invite you to participate in the public consultation on a clinical trial with candidate vaccines genetically modified against polio and developed by the University of Antwerp. The purpose of this trial is to evaluate the safety and immunogenicity of two new oral candidate vaccines for polio, live attenuated serotype 2. The public consultation runs from 14 May to 13 June 2018 inclusive.

The AFMPS has created an online database to hold information on all the clinical trials that it approves in Belgium and that have not yet been concluded. Healthcare professionals and patients will be able to use the database to query recruitment criteria of the clinical trials.

The FAMHP reiterates the guidelines that were published in July 2014 about the correct posology and certain precautionary measures when using medicines based on paracetamol. The therapeutic indication of paracetamol is the symptomatic treatment of fever and pain.

Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted. Accordingly, the RMA evaluation and approval deadlines have also been adapted. Moreover, fees must now be paid for the submission of applications for approval.