Data quality framework and first ever guide to the use of RWD metadata will empower data-driven medicines regulation in the EU

The European Medicines Agency and EU Heads of Medicines Agencies have jointly issued for public consultation a draft data quality framework and draft guide to the use of RWD metadata in order to increase the uptake and quality of RWD to drive EU medicines decision-making.

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The European Medicines Agency (EMA) and EU Heads of Medicines Agencies (HMA) joint Big Data Steering Group has issued two documents for public consultation, the draft Data quality framework for EU medicines regulation and the draft Good practice guide for the use of the metadata catalogue of real-world data sources. The objectives of these papers are to improve the quality of all data types, and specifically to facilitate the usage of RWD, in data-driven medicines decision-making in the EU.

The EMA and HMA produced the draft data quality framework together with Towards the European Health Data Space (TEDHAS) Joint Action. EMA, HMA and TEHDAS consulted a wide range of stakeholders during the development of the framework, including a workshop in April 2022 to collect input from experts in the field and learn from existing experiences. They followed this with a webinar in mid-October 2022 to present the draft framework to interested stakeholders and support the public consultation, which is open until 18 November 2022. The resulting document will receive ongoing regular updates in line with developments, including initiatives to support the European Health Data Space proposed by the European Commission.

Quality of data is key to data-driven regulation and supports the trust of patients and healthcare professionals. The EMA says, “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”. It sets out quality criteria standards to ensure data used in medicine regulation are fit for supporting benefit-risk decisions.

The draft good practice guide is the first ever to address the use of RWD metadata. It applies to the metadata catalogue of EU RWD sources that the EMA is currently compiling: in late 2023 the metadata catalogue will replace the existing catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Metadata characterize the observational RWD stored in repositories such as electronic health records and disease registries. The catalogue and guide together are intended to increase the discoverability of RWD and to help identify suitable RWD sources for particular studies. The public consultation on the RWD metadata guide is open until 16 November 2022.