New EU data quality framework aims to align stakeholders

The European Medicines Agency (EMA) on Monday published a data quality (DQ) framework intended to put stakeholders on the same page regarding data quality, as data has become more critical to regulating medical products.

The joint Big Data Steering Group, created by EMA and the Heads of Medicines Agencies (HMA), has published a document titled, Data Quality Framework for EU medicines regulation. It lists definitions, principles and guidelines that stakeholders can apply to a wide range of data sources to characterize and assess data quality used for regulatory decision-making.

EMA says that the progress in digitization and information technology, and the resulting plethora of data being generated in health care creates opportunities for regulators but also makes for an increasingly complex landscape for regulatory decision-making. The agency hopes to use the framework to get everyone involved to agree on definitions and terminologies to ensure high quality of the data that it uses when regulating products.

“As methods, terminologies, metrics and issues vary across different data types and sources this framework seeks to provide a coherent umbrella to identify, define and further develop DQ assessment procedures and recommendations for current and novel data types,” the document states. “Objectives of this framework are therefore to achieve consistency in DQ-related processes, enable the development of horizontal systems for DQ and eventually enable a more direct and automated use of data for regulatory decision making.”

The document builds on the recommendations proposed by the Towards the European Health Data Space (TEHDAS) project and takes into consideration feedback from a wide range of stakeholders who engaged with EMA, HMA and TEHDAS. Much of the definitions also result from an April 2022 workshop held by the organizations to get feedback from experts in the field and learn from existing experiences.

“In recent years, the EU regulatory assessment process has been progressively shifting from a predominantly document-based submission to a direct assessment of the underlying data used to create those documents,” EMA said. “This shift in process brings about the need for a framework, which would characterize the DQ and allows the regulator to make reliable assessments if the data are fit for the purpose of making decisions.”

“Data quality is a critical element for realizing the full potential of data-driven regulation and supports the trust of patients and healthcare professionals,” the agency added. “The draft Data Quality Framework for EU medicine regulation, now open for public consultation, sets out quality criteria for data used in medicine regulation to ensure they are fit for purpose to support benefit-risk decisions.”

EMA is encouraging stakeholders to comment on the document by 18 November and says it plans to regularly update the framework with developments including initiatives to support the European Health Data Space (EHDS) proposed by the European Commission. The agency also plans to host a public webinar on 18 October to present the framework and discuss it with stakeholders.

New EU data quality framework aims to align stakeholders

Related topics

Recommended content

Welcome to the new RAPS Digital Experience