March 20, 2024

News from the European Medicines Agency

Jose Drabwell, an IPOPI board member, attended the meeting of the Patients and Consumers’ Working Party organised by the European Medicines Agency (EMA) on 27 and 28 February 2024, in Amsterdam (the Netherlands). Jose was invited to present as a patient representative at the European Network of Paediatric Research (Enpr-EMA), a network of research networks, investigators, and centres with recognised expertise in performing clinical studies in children. More information on the work of Enpr-EMA can be found here.

The meeting held very interesting and relevant items for patients with primary immunodeficiencies, such as:

– An update on the Union list of critical medicines – as it was reported in the last e-News edition, the EMA published the first version of the Union list of critical medicines in December 2023 in which immunoglobulin replacement therapies were included. This first draft will now be subject to expansion and revision during the next months, with the view of having a final list later this year.

– Pharmacovigilance guidelines were also discussed during the meeting and participants of the meeting were informed by the European Medicines Agency and the European Commission of the envisaged steps to review the current requirements of pharmacovigilance. Pharmacovigilance relates to the activities associated with the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems. The EMA is very active in this area and more information can be found here.

If you want to know about the other aspects of the agenda or check the presentations provided, please click here.