The European Medicines Agency (EMA) has announced the publication of a guideline on registry-based studies following its adoption by the EMA’s cross-Committees Task Force on registries and the Committee for Medicinal Products for Human Use (CHMP).
The guideline provides pharmaceutical organisations with key methods and good regulatory practices on the planning and conduct of studies using patients registries’ data collection infrastructure or population to inform on medicines’ impact on public health. Additionally, the Annex proposes aspects of good practice in the establishment and management of patient registries considered relevant to their use for registry-based studies and other possible regulatory purposes.
For more information: https://www.ema.europa.eu/en/news/generating-high-quality-evidence-registry-based-studies