Initiative aims to support use of existing registries to collect information on medicines in clinical use and support benefit-risk evaluation

The European Medicines Agency (EMA) has launched an initiative on patient registries aimed at making better use of existing registries as a source of high-quality post-authorisation data for regulatory decision-making, and to facilitate the establishment of new registries if needed.

Registries collect information over time on patients who are diagnosed with a particular disease or who receive particular treatment(s). Regulators may sometimes require that pharmaceutical companies establish a registry to obtain information from clinical use in order to complement the data already available and to more effectively monitor the safety and efficacy of authorised medicines. In some cases, existing registries are available at national or international levels, e.g. operated by physicians’ associations or national agencies, which could be further utilised for this purpose. However, companies and regulators sometimes face challenges in using existing registries, including differences in requirements for types and structure of data provided. In cases where no suitable registry is available, a new registry will need to be established to collect these data.

The 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.

It is supported by a cross-committee task force on registries, which includes representatives from EMA scientific committees and working parties, representatives from the European Commission, and experts from national competent authorities.

The initiative includes two components: a strategy on registries and a pilot phase.

The strategy involves a planned collaborative approach to facilitating the interactions between coordinators of registries, regulators and pharmaceutical companies who need high-quality data on medicines in clinical use. Where needed, methodological components of newly established registries will be identified to ensure high quality and relevant data are collected.

The pilot phase aims to test whether the strategy meets regulators’ and other stakeholders’ needs for data and information on the basis of real-life examples. Participation in the pilot phase will be determined on a case-by-case basis by the cross-committee task force on registries. The pilot phase is anticipated to last for two years.


Posted on the EMA website on 12 October 2015