Latest EMA’s updates on the use of RWE in regulatory decision-making

The third annual report on the integration of real-world evidence (RWE) into regulatory decision-making shows a marked increase in the number of RWE studies conducted by the three pathways for generating RWE, the European consortium DARWIN EU, the framework contract (FWC), and in-house EMA studies. The PRAC Committee gave rise to the higher number of requests in the monitored period

New Approach Methodologies, the EMA’s horizon scanning report

The Horizon scanning report published by the European Medicines Agency and the Heads of Medicines Agencies discusses the challenges and opportunities for the development and implementation of New Approach Methodologies (NAMs) to support regulatory decision-making