Product Registries

Product Registries

EU: EMA Use of Patient Disease Registries for Regulatory Purposes – Product registries are patient registries where entry is determined by the prescription of a specific drug (as per Section 3.2 of EMA – Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, Nov 2018)

USA: Registries for Evaluating Patient Outcomes: A User’s Guide – Product registries, by definition, focus on patients treated with a particular medical product. To be useful, the registry should record specific information about the products of interest, including route of administration, dose, duration of use, start and stop date, and, ideally, information about whether a generic or branded product was used (and which brand) and/or specific information about the product. Biologic medicines and devices have their own challenges, ideally requiring information about device identifiers, production lots, and batches (as per Section 19.2.1 of AHRQ Registries for Evaluating Patient Outcomes: A User’s Guide [Internet]. 3rd edition)