After a fertility centre contacted the Federal Agency for Medicines and Health Products, it emerged that its dossier on the sperm donor carrying the TP53 gene mutation was incomplete, as two additional children were reported. FAMHP inspectors immediately visited the centre for an inspection. The procedure is still underway. The FAMHP considers that the fact that the centre is communicating these elements only now, despite previous information and questions, is very serious.

During its June 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). Furthermore, the PRAC is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.

The FAMHP has set up an internal crisis unit in response to news of a specific donor carrying a potentially carcinogenic TP53 gene mutation, and the fact that the limit of six women per donor has been exceeded.

The FAMHP now publishes a list of medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 and 2017/746, introduced by the regulation (EU) 2024/1860. In other words, medical devices that are temporarily (interruption) or permanently (discontinuation) absent from the Belgian market and whose unavailability could result in serious harm or a risk of serious harm to patients or public health.

From 1 June 2025, the Federal Agency for Medicines and Health Products (FAMHP) will introduce a new contact form for firms that have questions around their files of variations and renewals for medicinal products for human use.

At its May 2025 meeting, the European Medicines Agency Risk Assessment Committee proposed new risk mitigation measures for finasteride and dutasteride. Suicidal thoughts were confirmed as an adverse effect for finasteride, but not for dutasteride. Belgium does not agree with the conclusion. The PRAC also initiated a review of Ixchiq (live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.

Healthcare institutions often develop their own software to support patient care. This software has to comply with the legal requirements and obligations described below.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SPVN20 for the treatment of rod-cone dystrophy. The public consultation will take place from 19 May to 18 June 2025.