Sustainable framework to support scientific evaluations in the EU
By complementing existing evidence, use of real-world data (RWD) and real-world evidence (RWE) can speed up medicine development and support post marketing safety and effectiveness monitoring.
Overseen by the Big Data Steering Group (BDSG), EMA and the European medicines regulatory network (EMRN) are working to establish a sustainable framework enabling better integration of RWD/RWE into regulatory decisions. Pilots with EMA scientific committees and working parties (COMP, PDCO, SAWP, CHMP and CAT) are ongoing. EMA has reviewed the experience gained so far in conducting studies with RWD and the
challenges and opportunities of providing RWE to support regulatory decision making…
