EMA opens public consultation on Data Quality Framework for RWD

The framework aims to provide regulators with a structured approach to assess the quality of real-world data (RWD), ensuring its appropriateness for generating robust real-world evidence (RWE) in regulatory assessments.

The European Medicines Agency (EMA) has launched a public consultation on the application of the Data Quality Framework (DQF) to RWD in the context of EU medicines regulation. This initiative aims to enhance the use of RWE in regulatory decision-making, providing stakeholders—including regulators, pharmaceutical companies, and academic entities—with the opportunity to contribute their insights.

The draft chapter under consultation provides guidance for assessing the quality of RWD for use in regulatory contexts. It emphasizes the importance of evaluating key elements such as data collection methods, reliability, coherence, and representativeness to determine the data's reliability and relevance in addressing specific research questions. The draft provides actionable recommendations for assessing RWD quality, supporting the evaluation of data using metrics and evidence of processes that underpin the data. This guidance is expected to enhance the utility of RWE in regulatory assessments by ensuring consistent methodologies across datasets.

The EMA highlights that the framework, referred to as RW-DQF, is designed to address the challenges associated with using RWD for regulatory purposes. According to the EMA, the RW-DQF, "sets out the specificities of RWD and enable[s] regulators to evaluate the quality of data underpinning RWE as used in the regulatory assessment." This framework aligns with other significant health data initiatives, such as the European Health Data Space (EHDS) and Towards European Health Data Space (TEHDAS). By maintaining consistency with these projects, the RW-DQF aims to streamline and improve the use of health data in regulatory decision-making processes.

The consultation opened on November 29, 2024 and will run until January 31, 2025. The consultation process is straightforward, allowing stakeholders to submit their comments via the EU Survey tool, without needing a login. Submissions can be edited until the deadline, providing contributors with flexibility to refine their input. This inclusive approach is intended to encourage a diverse range of perspectives from key stakeholders, including pharmaceutical companies, academia, and collaborative entities like DARWIN EU®. The insights gathered will play a critical role in shaping how RWD is used to support medicine regulation across the EU.