During its May 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. The PRAC discussed direct healthcare professional communications (DHPCs) containing important information on fluoroquinolone antibiotics and Gavreto.

In the context of the new clinical trials regulations (CTR), on 15 September 2023,the FAMHP is organising an information session on early phase clinical trials.

Since 2019, negative formulations are no longer allowed on the packaging of medicinal products for human use in Belgium. This decision came after consultation at European level and in agreement with the other European Member States. The FAMHP will therefore reject such formulations.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified medicine RO7494222 (SRP-9001) for the treatment of Duchenne muscular dystrophy. The public consultation runs from 29 March to 28 April 2023.

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.