News

CT CURE extends expedited review of multinational clinical trial applications on COVID-19 therapeutics

CT CURE, coordinated by the FAMHP, is the European Union’s (EU) joint action seeking ways to expedite assessment and decisions on multinational clinical trial applications related to COVID-19 therapeutics and has entered its final year. The project involves 15 EU Member States and now extends its scope to therapies that bridge the gap between therapeutic and preventive treatments in order to include as many clinical trials as possible and make the European Union a more attractive region for large, multi-country trials using master protocols.

PRAC April 2024 – PRAC finds no link between suicidal thoughts and thoughts of self-harm and GLP-1 receptor agonists and new safety information for HCPs on new Rybelsus tablets

During its April 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no available evidence supporting a link between GLP-1 receptor agonists and suicidal thoughts and thoughts of self-harm and advice to CHMP on new Rybelsus tablets.

Shifting towards needs-driven healthcare: highlights from the Belgian high-level conference

On 17 and 18 April, the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI) and the Health Care Knowledge Centre (KCE) organised a high-level conference on health-related needs as drivers for healthcare policy and innovation. This conference was organised in the context of the Belgian presidency of the Council of the EU. The aim is to establish a research and innovation ecosystem that focuses on the most pressing health needs.

Warning of counterfeit ivermectin tablets sold via social media

The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.

Marketing authorisation holders: mandatory update of contact details in product information for reporting adverse reactions to the FAMHP

The current postbox address of the FAMHP is no longer applicable. The contact details for reporting adverse reactions to the FAMHP should be changed by marketing authorisation holders in the product information of medicinal products for human use as soon as possible.