News Brief:  EMA and HMA Joint Workplan on Data and AI in Medicines Regulation

EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan, Data and AI in medicines regulation to 2028, which maps how they will leverage large volumes of regulatory and health data and utilize new tools to encourage research and innovation. The goal is to support regulatory decision-making for better medicines that reach patients faster.

"In view of the technology-driven explosion of data, we need to be strategically aligned across the EU in terms of data governance, management and AI-powered analysis tools to transform data into tangible benefits for public and animal health,” said Peter Arlett, EMA’s Head of Data Analytics and Methods Task Force and co-chair of the Network Data Steering Group (NDSG).

The workplan provides a roadmap for managing, analyzing and sharing data across the European Union (EU) regulatory network, while adhering to high security and ethical standards. It also provides a framework for coordination to address new legislative initiatives in the EU, notably the pharmaceutical legislation, the European Health Data Space (EHDS), the Interoperable Europe Act and the AI Act.

The workplan was announced on the following website on 7 May: https://www.ema.europa.eu/en/news/leveraging-power-data-public-animal-health