EMA – Draft of Data Quality Framework for EU medicines regulation application to real-world data
The EMA is currently carrying out a public consultation on the Data quality framework for medicines regulation chapter dedicated to real-world data .
The chapter under consultation provides guidance on how to assess the quality of real-world data in the evaluation of medicines. It aims to enhance the use of real-world data in regulatory decisions.
This 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.
The consultation deadline is 31 January 2025.
More information on the Data Quality Framework for EU medicines regulation on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2024). EMA – Draft of Data Quality Framework for EU medicines regulation application to real-world data. ELSIBI. Consulté le 13 janvier 2026 à l’adresse https://doi.org/10.58079/12wce





