EMA Highlights Trial Innovation, Real-World Data Advances

The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trials and a new real-world data (RWD) network.

The 65-page report, which looks at progress made from March 2020 to December 2022, notes the launch of the EU’s Clinical Trials Information System, which went live as a searchable public website in January 2022. The agency also launched the Accelerating Clinical Trials initiative to help develop the EU as a center for innovative clinical research.

Other advances included building the Data Analysis and Real-World Interrogation Network, publishing a catalog of observational data sources to be used in medicine regulation, publishing an executive summary about the best approach to generate and collect patient experience data, and holding a stakeholders’ workshop to support developers.

The EMA said it expects the progress to continue in the next two years.