EMA - Generating high-quality evidence from registry-based studies

27th October 2021

EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies.

A patient registry is an organised system that collects uniform data over time on patients who are diagnosed with a particular disease or condition, or who receive particular medicines. A registry-based study is a clinical trial or a non-interventional study that investigates a research question using the data collection infrastructure or the patient population of one or several patient registries.

For more information, click here.

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