EMA launches initiative for better use of patient registries

The European Medicines Agency today launched an initiative on patient registries aimed at making better use of existing registries as a source of high-quality post-authorization data in medicines 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 authorized medicines. In some cases, existing registries are available at national or international levels, eg, 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.

Aims to address current challenges faced by industry and regulators