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

News 10/10/2022

emA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the quality of the data that underpin decision-making on the benefits and risks of medicines in the European Union (EU).

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.

Quality of data is key to data-driven regulation

Data quality is a critical element for realising the full potential of data-driven regulation and supports the trust of patients and healthcare professionals. 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.

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 characterisation 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.

EMA, HMA and TEHDAS consulted a wide range of stakeholders during the development of this framework and organised a workshop in April 2022 to collect input from experts in the field and learn from existing experiences. A follow-up webinar will take place on 18 October to present the draft framework to interested stakeholders and support the public consultation.

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.

First ever guide for the use of real-world metadata

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 characterise 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.

Data Quality Framework for EU medicines regulation

PDF阅读下载：https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf

Good practice guide for the use of the Metadata Catalogue of Real-World Data Sources

PDF阅读下载：https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-use-metadata-catalogue-real-world-data-sources_en.pdf

来源：European Medicines Agency 官网 2022年10月10日

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