Patient registries are a means of collecting patient data following treatment with newly authorised medicinal products when there is a need for ongoing analysis of the benefit–risk relationship. The European Medicines Agency (EMA) has established a new patient registry initiative to explore ways of dealing with current challenges faced by companies and regulators in using existing registries and establishing new registries if needed. This initiative will involve experts from EMA itself as well as the European Commission and national competent authorities, and will comprise the development of a strategy on registries and a pilot phase expected to last 2 years. Full details can be found here.
Author: Anthony Lodge