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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).

Less than a year to go before clinical trials transition to new EU system. FAMHP hosts webinar for all stakeholders

All ongoing clinical trials in the EU must have transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. The FAMHP is hosting a webinar for all stakeholders on 13 June 2024.

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.

Fighting antimicrobial resistance: a new antimicrobial medicinal product marketed in Belgium

In the fight against antimicrobial resistance, it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. Eravacycline, a new antibiotic active substance, has recently been launched on the Belgian market.

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.

Fighting antimicrobial resistance: a new antimicrobial medicinal product marketed in Belgium

In the fight against antimicrobial resistance, it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. Maribavir, a new viral active substance, has recently been launched on the Belgian market.

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.

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