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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 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 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.

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.

From May 1, 2018 the FAMHP is simplifying a number of procedures for homoeopathic and (traditional) herbal medecines with the intention of streamlining the process and reducing the administrative load for companies and the government.

In 2017, FAMHP saw a 37% increase in the number of side effects reports received. This remarkable progress is an encouraging sign of ongoing improvements in the safety profiles of medicines; however, FAMHP would still like to encourage all health care professionals to report more side effects.

Brexit has led to a larger number of files relating to changes in Reference Member State (RMS). A new template has accordingly been developed to streamline this process.