March 31, 2025
News from the European Medicines Agency
The European Medicines Agency is an agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the European Union. There have been some interesting developments in the past months:
- The European Commission has launched a new website displaying all clinical trials taking place in the EU. The new website is very informative, as it contains information on currently recruiting or ongoing trials, including the centres participating and the responsible person per centre, as well as details on the conditions studied, inclusion and exclusion criteria and the objectives of the trial (endpoints). The website can be accessed here (https://euclinicaltrials.eu/search-for-clinical-trials/trial-map/?lang=en)
- The Workshop on the challenges in drug development, regulation and clinical practice in immunoglobulins, on March 5, aimed at presenting the regulatory requirements for the clinical development of immunoglobulins (Igs) in support of a marketing authorisation application; present the clinicians’ and healthcare professionals’ perspective on the use of Igs and their views on established and new indications; and present perspectives from industry and health technology bodies on the use of Igs. This workshop was organised while the EMA launched a public consultation on two documents: 1) the scientific guideline on the clinical investigation of Ig for subcutaneous and/or intramuscular administration and 2) the core Summary of Product Characteristics (SmPC). More information on the workshop can be found here https://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-immunoglobulins
- The Committee of Human Medicines has given a positive opinion to Deqsiga, an immunoglobulin(Ig) solution available as 100mg/ml solution for infusion. This Ig would contain lower levels of IgA than Kiovig. The therapy now needs to get the green light from the European Commission to be marketed in the EU. It is, unfortunately, not the end of the story, as it would come to EU Member States to decide whether this medicine is reimbursed (and if so, to which extend) with the manufacturing company. More information here.
The EMA’s post in memory of Jose can be found here
