News FAMHP

The FAMHP reminds marketing authorisation holders of the obligation to add recommendations on the use of contraception to the package leaflet of genotoxic medicines.

FAMHP organises two information sessions, in collaboration with its stakeholders, for sponsors and applicants on 23 September 2021 and on 25 November 2021 on the new Clinical Trial Regulation (CTR).

The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability. While waiting for a sufficient quantity of the medicinal product to return to the market, the FAMHP experts recall the recommendations for the rational use of stocks of Bleomycine Sanofi 15,000 IU that may still be available.

The FAMHP has once again renewed a number of measures in a new decision by the Chief Executive Officer of the FAMHP. This decision has once again been taken to avoid medicine shortages in the context of the coronavirus pandemic (COVID-19).

During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.

The European Medicines Agency (EMA) has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium.

During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.

On 26 May 2021, EU Regulation 2017/745 on medical devices entered into force. This new Regulation addresses the needs for innovation, security and traceability.

As is customary and with full transparency, the FAMHP publishes the figures and results for 2019 for all its services and activities. You are receiving this annual report later than you would normally expect from us, as the COVID-19 health crisis has been given priority over the past year. The annual report contains many novelties, rising and falling trends and interesting figures. 2019 was a year of progress, you can read all about it in the FAMHP digital annual report, which is available again in four languages.

Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.