EMA – Publication of Real-world evidence framework to support EU regulatory decision-making: 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024

The EMA published its 2nd report on the Real-world evidence framework to support EU regulatory decision-making for the period between February 2023 and February 2024. This report builds on the experience previously acquired during the period from September 2021 to February 2023 in conducting regulatory-led studies using real-world data (RWD) to support EU regulatory decisions (see previous report here). It covers the period from 8 February 2023 to 7 February 2024, which corresponds to year 2...