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What are 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. High-quality patient registries can make valuable contributions to the evaluation and monitoring of
medicines for public health benefit, especially in relation to their safety and notwithstanding that most registries were not established for this purpose.

Regulators and pharmaceutical companies currently face a number of challenges in using existing registries or establishing new ones to support medicines evaluations during the marketing authorisation process, including a lack of

- coordination between ongoing initiatives at national and international levels
- harmonised protocols, scientific methods and data structures
- data sharing and transparency
- long-term sustainability of registries.

These factors have led to under-use of existing patient registries, inefficiency when registries are used, non-useable registries, and a duplication of efforts.

EMA Guideline - Registry-based studies 2021

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