EU: New Data Quality Framework for Medicines Regulation

On 10 October 2022, the EMA published a 24-pages document on data quality (DQ) framework, which is open for consultation until 18 November 2022. As the topic of data quality and data overall becomes more and more critical to regulating medicinal products, a Data Quality Framework for EU medicines regulation is a logical consequence to provide a unitary approach. Thus, the amount of data that digitalisation brings along not only opens up new possibilities, but also increasingly complex data landscapes.

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