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.

Medication errors have occurred with injectable forms of GLP-1 analogues and dual GIP/GLP-1 analogues. Below are a few reminders for a proper use of these medicines.

As of 28 May 2026, it will be mandatory to use the first four modules of the European database on medical devices. This follows a decision published by the European Commission.

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.

Ever more healthcare institutions are developing their own digital tools. This obviously raises some questions: what about regulations and patient safety? Therefore, the FAMHP is organising a study day on in-house software. Please mark your calendar for 10 March 2026.

The medical devices HeartSine samaritan PAD models SAM 350P/360P/450P/500P, as well as the HeartSine samaritan Pad-Pak and Paediatric-Pak units, are subject to two safety actions due to potential malfunctions or failures of certain defibrillators and accessories.

On Tuesday 18 November 2025, the Federal Agency for Medicines and Health Products (FAMHP) once again appeared before the House of Representatives regarding the sperm donor case involving a sperm donor who carried a TP53 gene mutation and the failure to comply with the legal limit of six women per donor.

As every year, the World Antimicrobial Resistance Awareness Week (18-24 November 2025) is raising awareness of the need to take action in the face of this public health challenge. The FAMHP is also actively working on this challenge.