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Data-driven Medicines Regulation in the European Union

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 set up by EMA and the Heads of Medicines Agencies (HMA) has endorsed two documents for public consultation, one looking at the quality of all data types used in regulatory decision-making, the other one focusing specifically on the discoverability of real-world data.

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 framework addresses principles and procedures that apply across data types and across regulatory activities. It also provides considerations on data quality, definitions for data dimensions and sub-dimensions, as well as their characterization and related metrics.

The framework seeks to provide a coherent umbrella to identify, define and further develop data quality assessment procedures and recommendations for current and novel data types.

The draft Data Quality Framework has been produced by EMA, HMA and the Towards the European Health Data Space (TEHDAS) Joint Action. The public consultation is open until 18 November 2022.

The document will be updated regularly in line with developments including initiatives to support the European Health Data Space (EHDS) proposed by the European Commission.

The second document out for public consultation is a draft good practice guide for the use of the EU metadata catalogue of real world data sources. It is the first guide produced worldwide to focus on metadata to empower systematic integration of real-world evidence in medicines regulation.

The guide provides recommendations on how to use the catalogue of real-world metadata that is currently being built and in late 2023 will replace the existing catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

The guide will help to identify suitable real-world data sources for studies and describes the metadata elements that will be used. The public consultation is open until 16 November 2022.

Real-world data are observational data stored in repositories such as electronic health records and disease registries. Metadata characterize real world data and are essential to improve data discoverability, create a clearer understanding of their meaning and achieve greater reliability and quality when using them to improve the evidence available for benefit-risk decisions. Overall, they help to get better medicines to patients.

Resource Person: Barbara Pirola

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