The framework published by the EMA and the HMA (Heads of Medicines Agencies) addresses the representativeness and quality of data as a basis for regulatory decisions. For stakeholders, the document provides definitions for data dimensions and sub-dimensions, terminologies, principles and general guidance that can be applied in characterising and assessing the relevant data quality. In addition, quality criteria are defined for data used in medicines regulation. This is to ensure that data are appropriate for the consistency of benefit-risk decisions.

The document already takes into account feedback from various stakeholders who have worked with the EMA and the HMA. Much of the definitions stem from an expert workshop held in April 2022.

Comments on the document are possible until 18 November 2022. The framework will be continuously updated and adapted to developments in the future. A public webinar will be held on 18 October.

Source:

EMA: Data Quality Framework for EU medicines regulation

EMA: High-quality data to empower data-driven medicines regulation in the European Union