Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.
Update on the guidance document to assist clinical trials sponsors as part of the pilot project of the FAMHP
Based on the evolution of the pilot project for the new Clinical Trial Regulation, the FAMHP made an update on the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials.
During the meeting of 28 - 31 October 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) implemented measures to minimise risk of serious side effects with Lemtrada. Furthermore, the PRAC recommended Xeljanz to be used with caution for all patients at high risk of blood clots.
The FAMHP asked more than 12,000 francophone university students about the use of stimulant drugs. 5% of them said to use stimulant medicines for non-medical use, in order to study better.
The European Medicines Agency (EMA) and the competent medicine authorities of the European member states, including the FAMHP, have been notified that in a small number of diabetes medicines based on metformin outside of the European Union, a nitrosamine contamination (NDMA, N-nitrosodimethylamine) has been detected. Currently, analyses are being performed on the medicines within the European Union.
As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.
The FAMHP launches PharmaStatus, the new online application that collects information about the availability of medicines in Belgium and makes it public. Current information will help patients, doctors, pharmacists and the pharmaceutical industry to limit the impact of unavailable medicines.
The fight against anti-microbial resistance continues: the Belgian BAPCOC 2019 antibiotics guide is available on the CBIP website
As recommended by the Belgian Health Care Knowledge Centre (KCE), a new step in the fight against anti-microbial resistance has been taken: the 2019 edition of the Belgian Antibiotic Policy Coordination Committee (BAPCOC)’s antibiotics guide is available online on the Belgian Pharmacotherapy Information Centre (CBIP) website.
Campaign to report side effects: in 2019, focus on interactions during simultaneous use of various medicines
The fourth #MedSafetyWeek runs from November 25 to 29, 2019. Competent authorities from all over the worlds are participating in a social media campaign to draw attention to the importance of reporting side effects of medicines. This year, the campaign focuses on possible interactions when various medicines are used at the same time.
The Federal Agency for Medicines and Health Products (FAMHP) is holding a symposium on vaccines on Friday 6 December 2019. The symposium will highlight certain current challenges in the development of new vaccines and the improvement of existing vaccines. Spekers will also talk about the role of various Belgian public institutions in bringing vaccines to market and monitoring them.