As of 1 January 2026, sponsors will not be charged a fee for the Clinical Trial Regulation safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System, provided that these issues occurred after validation.
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The FAMHP is launching a dashboard with up-to-date figures and statistics for clinical trials
The FAMHP is launching a new dashboard with up-to-date figures on clinical trials in Belgium. With this initiative, the agency aims to increase transparency and further support the clinical research sector.
Rybelsus – Reminder: risk of medication errors due to the introduction of a new formulation
From 1 April 2026, Rybelsus tablets (oral semaglutide) will be replaced by a new formulation that offers improved bioavailability. Both formulations will temporarily coexist on the market, which may lead to confusion and a risk of overdose.
Give your opinion on a genetically modified medicine against Duchenne Muscular Dystrophy
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine GNT0004 for the treatment of Duchenne Muscular Dystrophy. The public consultation will take place from March 9th to April 8th 2026.
Launch of the new online application HemoVigilance
The FAMHP is launching HemoVigilance, a new online application for reporting serious adverse reactions related to the donation or transfusion of blood and blood components. The application also allows users to report any serious adverse incidents that have an impact on the quality and safety of labile blood components to the FAMHP.
PRAC February 2026 – PRAC recommends the withdrawal of medicines containing levamisole
During its February 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended the withdrawal of medicines containing levamisole from the EU market. These medicinal products are not marketed in Belgium, but are included in the World Health Organisation list of essential medicines.
Give your opinion on a genetically modified medicine against Stargardt Disease
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine AAVB-039 for the treatment of Stargardt Disease. The public consultation will take place from February 28th to March 30th 2026.
Unavailability of Holoxan 1 g powder for solution for injection for intravenous use: recommendations for physicians specialists and hospital pharmacists
Due to a delay in production, the oncological medicinal product Holoxan 1 g powder for solution for injection for intravenous use has been unavailable since 28 January 2026.
Share your feedback on the new contact form for variations and renewals
In 2025, the FAMHP introduced a new web form for questions on variations and renewals. This form should make it easier and more efficient to submit your questions. Please let us know what you think so we can continue to improve it.
Give your opinion on a genetically modified medicine against Amyotrophic Lateral Sclerosis
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine VTx-002 for the treatment of Amyotrophic Lateral Sclerosis (ALS). The public consultation will take place from February 9th to March 11th, 2026.