EMA Launches Patient Registry Initiative

On Oct. 12, 2015, the European Medicines Agency (EMA) announced the launch of a patient registry initiative to use existing registries as a source of post-authorization data for regulatory decision making and to facilitate the establishment of new registries. According to the agency, regulators may require the use of information collected by registries on patients diagnosed with a particular disease or treatment to complement data already available and to monitor the safety and efficacy of authorized drugs. The EMA patient registry initiative “will explore ways of dealing with current challenges faced by companies and regulators in using existing registries and establishing new registries if needed,” the agency said in a press release.

A cross-committee task force on registries that includes representatives from EMA scientific committees and working parties, representatives from the European Commission, and experts from national competent authorities, will support the initiative.

The initiative includes a strategy for a planned collaborative approach to facilitating the interactions between coordinators of registries, regulators, and pharmaceutical companies. A pilot phase will test whether the strategy meets regulators' and other stakeholders' needs for data and information on the basis of real-life examples.