EMA - Data Quality Framework for EU medicines regulation: application to Real-World Data Public Consultation

11th December 2024

EMA - Data Quality Framework for EU medicines regulation: application to Real-World Data

The document describes the Real-World Data (RWD) specific recommendations as derived from the Data Quality Framework (DQF) for EU Medicines regulation endorsed by the Committee for Medicinal Products for Human Use (CHMP). The EMRN DQF sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases. It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring DQ in the regulatory context.

Comments should be provided by 31 January 2025 using this EU survey.

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