Database for clinical trials

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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.

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.

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 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.

Last updated on 29/06/2017