News

EMA publishes new data on sales and use of antimicrobials in animals within the European Union

The European Medicines Agency publishes the second European Sales and Use of Antimicrobials for Veterinary Medicine report and launches a new platform to improve monitoring of data on the use of antimicrobials in animals. The report shows a slight increase in antimicrobial sales, an increase of 5 % in 2024 compared to 2023.

Donor TP53 - What measures have been taken in Belgium?

The European press has published information about a Danish sperm donor who carries a rare genetic mutation (TP53). Many European countries have been affected by this. In Belgium, this case has received extensive media coverage since May 2025, and several parliamentary hearings have taken place in which the FAGG responded to questions from federal parliamentarians.

New Royal Decree on parallel distribution and parallel import of medicinal products for human use effective from 11 December 2025

From 11 December 2025, a new Royal Decree will come in force that fundamentally changes the rules on parallel distribution and parallel import of medicinal products for human use in Belgium. The decree simplifies administrative steps and provides more transparency.

FAMHP speeds up assessment of clinical trials to bring innovative treatments to patients more quickly

From 1 January 2026, the FAMHP will introduce accelerated timelines for the assessment of initial clinical trial applications concerning medicinal products for human use. This measure ensures that clinical research can start faster, to the benefit of the patient, and strengthens Belgium's top position as a centre for clinical trials.