12 October 2015 - 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.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/10/news_detail_002413.jsp&mid=WC0b01ac058004d5c1