Regulatory Focus™ > News Articles > Patient Registries: EMA Wants to Make Better Use of Medicines Data

Patient Registries: EMA Wants to Make Better Use of Medicines Data

Posted 24 October 2016 | By Zachary Brennan 

Patient Registries: EMA Wants to Make Better Use of Medicines Data

The European Medicines Agency (EMA) on Friday is hosting a workshop to discuss ways to better use existing patient registries that collect high-quality data on drugs in clinical practice.

Patient registries collect information over time on patients with a particular disease or who receive particular treatment during both pre-authorization and post-authorization periods. Such data can complement data from other sources to more effectively monitor drug risks and benefits.

Regulators sometimes require pharmaceutical companies to establish a registry to collect such safety and efficacy data in clinical practice. And although existing registries are sometimes available at national or international levels, there are often challenges in using them, EMA notes, particularly due to lack of access and collaboration, as well as because of differences in the type and structure of the data collected.


The 28 October workshop, which will be broadcast live on the EMA event page, will focus on: Identifying the challenges and opportunities for collaboration, understanding the technical challenges of existing registries and identifying ways to facilitate collaboration and better use existing data.

EMA says it seeks to promote tools and standards to support a better approach to registries, with two components: a new strategy on registries and a pilot phase, expected by the end of 2017, to test different components of the strategy.

EMA’s initiative on patient registries is supported by a task force comprising representatives from EMA scientific committees and working parties, representatives from the European Commission and experts from national competent authorities.

EMA is organizing this workshop as part of a broader initiative launched in September 2015 to explore ways of expanding the use of patient registries.

How to make better use of patient registries to collect high-quality data on medicines

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.