EMA Vouch to Increase Access and Improve Quality of Data-Driven Medicine Regulation
October 2022 saw the official announcement that the EMA and the Heads of Medicines Agencies (HMA) are set to empower data-driven medicines regulation across EU Member States for 2023. So far, two documents for public consultation have been drafted. The first outlines a data quality framework for EU medicines regulation and the second focuses on best practices for real-world data usage.
Data Quality Framework for EU Medicine Regulation
Data quality is a measurement determining a proposed data set's accuracy, consistency, reliability, completeness, and relevance. Appropriate data quality is critical for achieving data-driven regulation and provides an essential foundation for the trust of both patients and healthcare providers.
The EMA's draft document "is the first release of the EU data quality framework for medicines regulation and addresses high-level principles and procedures that apply across the European Medicines Regulatory Network (EMRN) 's regulatory activities."
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The document defends the advent of such guidelines in the following words: "Identification of appropriate data sources is becoming an increasing need for regulatory decision-making. While data needs are becoming more complex, standardised information and statistics on real-world data sources is lacking."
The EMA's draft document "is the first release of the EU data quality framework for medicines regulation and addresses high-level principles and procedures that apply across the European Medicines Regulatory Network (EMRN) 's regulatory activities."
In response, the regulation endorses the practice of metadata: "descriptive data that characterise other data to create a clearer understanding of their meaning and achieve greater reliability and quality when using the data for a specific purpose". The framework provides a set of best practices to identify, define, and develop data quality assessment procedures. It likewise outlines considerations for novel data types as well as definitions for data dimensions and sub-dimensions.
Making History: The First Ever Guide for Real-World Metadata Use
The second document released is a good practice guide for the EU metadata catalogue of the real-world data source. It is the first guideline created globally that focuses on employing metadata to empower real-world evidence integration in regulation.
According to the document, "the Good Practice Guide aims to provide recommendations for the use of the EU metadata catalogue to identify real-world data sources suitable for specific research questions and to assess the suitability of data sources proposed to be used in a study protocol or referred to in a study report."
The guide also "provides a detailed description of all the metadata elements as envisaged to be used in the EMA catalogue, which have been published by HMA/EMA in the List of metadata for Real World Data catalogues, and it guides the user for the insertion and maintenance of data in the catalogue." The catalogue being built will replace the existing catalogue provided by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
This catalogue is targeted for release in late 2023.
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