A new system for financing the surveillance of the medical devices market applies from 2023. This system aims to make fees fairer between the different stakeholders in the sector, as each one must pay a fee that is consistent with its turnover and with the level of risk involved in its activity and in the workload it represents for the FAMHP.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicinal product JNJ-81201887 (AAVCAGsCD59) for the treatment of geographic atrophy secondary to age-related macular degeneration. The public consultation runs from 22 March 2023 to 21 April 2023.

The FAMHP and the NIHDI wish to remind prescription software suppliers of a number of homologation requirements for the order of presentation and selection of medicinal products and non-medicinal products.

Due to production problems of Sabril 500 mg, a medicinal product used for epilepsy, there has been a critical shortage in Belgium since February 21, 2023. A task force is making recommendations.

During its February 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started a review of medicines containing pseudoephedrine.

The European Commission's new Delegated Regulation (EU) 2023/196 adds five drug precursors to the list of scheduled substances. These are substances that can be used to produce fentanyl or amphetamines. The trade, possession and use of these substances are subject to governmental supervision. The regulation enters into force on 20 February 2023.

Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors and New safety information for healthcare professionals for Zolgensma

The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.