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6th Vigilance Day
15 October 2019 - More information
Annual Report 2018
At its July 2019 meeting, EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in September. Professor Norga will replace Dr Dirk Mentzer who is retiring as PDCO Chair, having served the maximum of two three-year mandates.
When reporting side effects in the product information, one can now refer to the FAMHP’s post box address.
Last year, the e-PIL pilot project on the electronic patient information leaflet started. Hospital pharmacists will soon receive a link to an online survey to evaluate the project, one year after its start.
Later this year, the European Commission will launch a call for experts in medical devices and devices for in-vitro diagnostics. They will form expert panels to provide advice and assess new risky devices.
The U.S. Food and Drug Administration (U.S. FDA) has recognized all 28 EU member states. This means that starting 11 July 2019, the United States (US) and the European Union (EU) have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.
The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium.
The European Medicines Agency (EMA) is reassessing the risk of meningioma on medicines based on cyproterone, a risk that has long been known to medical professionals. A French study suggests that the risk of meningioma, even though small, can be greater in women who have taken high doses of cyproterone over long periods of time.
During its meeting of July 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended new measures to avoid dosing errors with methotrexate. Furthermore, the PRAC started a review of meningioma risk with cyproterone medicines