News FAMHP

The European Commission has issued a second call for Member State laboratories to submit applications to become a European Union reference laboratory for in vitro diagnostic medical devices. The designation of these laboratories is provided for in Article 100 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The FAMHP, EMA and the Heads of European Medicines Agencies warn about unregulated products in the EU, including dendritic cell cancer therapies.

Biovigilance ensures systematic monitoring, from donor selection to recipient follow-up, in order to guarantee safer and more efficient use of tissues and cells. In this 2023 report, all SAEs and SARs that occurred during the processing and use of SoHO from 1 January 2023 to 30 June 2024 have been compiled.

In April 2024, the Critical Medicines Alliance was established under the Belgian Presidency of the Council of the European Union. The goal of the Alliance is to foster collaboration among policymakers and stakeholders, and develop a robust and responsive system for the supply of critical medicines in the European Union. Today, on 28 February 2025, the Critical Medicines Alliance presents its strategic report. This report will be used as the basis for new European legislation on medicines shortages: the Critical Medicines Act.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified hepatitis B vaccine vaccine LAV-YF17D/HBc (AVX70371). The public consultation will take place from 28 February 2025 to 30 March 2025.

In January 2025, the Committee for Veterinary Medicinal Products of the European Medicines Agency issued a positive opinion on an application for authorisation under Article 25 for the immunological veterinary medicinal products Syvazul BTV-3 and Bluevac-3. Both products will therefore shortly be given a marketing authorisation.

Since February 2020, the European Union Innovation Network has been running a pilot project for simultaneous national scientific advice provided by multiple national competent authorities at the same time. Following a positive evaluation of the results of the simultaneous national scientific advice pilot project at the Heads of Medicines Agencies meeting in January 2025, the continuation of the concept was supported.

Marketing authorisation holders must submit the 2024 sales volumes of veterinary medicinal products to the UPD by 28 February 2025.

During its January 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of medicines containing semaglutide following concerns regarding an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION).

Customs, the Federal Police, the Federal Agency for Medicines and Health Products (FAMHP), the Federal Agency for the Safety of the Food Chain (FASFC) and anti-doping organisations (NADO Flanders, ONAD Fédération Wallonie-Bruxelles, ONADO Brussels) took part in operation SHIELD V, coordinated by Europol. This operation ran from April to November 2024 and targeted counterfeit medicines, doping and food supplements.