Patient registries
Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide an adequate source of post-authorisation data for regulatory decision-making.
Human
Regulatory and procedural guidance
Pharmacovigilance