News

Unavailability of Rabipur: recommendations for medical doctors (specialists) and pharmacists

Bavarian Nordic, the company that holds the marketing authorisation for Rabipur (Powder and solvent for solution for injection in pre-filled syringe - Rabies virus (inactivated, strain Flury LEP)) has notified the FAMHP that the medicinal product will be unavailable until 31 August 2024 due to a delay in the release of the final product. The Federal Agency for Medicines and Health Products (FAMHP) convened a task force with experts in order to find solutions.

Training session on ‘Emergency Preparedness through Platform Trials in the European Union-European Economic Area’ on September 5th and 6th, 2024, in Brussels

CT CURE, the European Union’s joint action, will conduct the training session titled ‘Emergency Preparedness through Platform Trials in the European Union - European Economic Area’ on September 5th and 6th in Brussels. The training is designed specifically for assessors of clinical trial applications from Medical Research Ethics Committees and National Competent Authorities.

PRAC May 2024 – 17-hydroxyprogesterone caproate medicines to be suspended from the EU market

During its May 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). 

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.