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

"E.I.P.G. is a European association representing the national, professional organizations of pharmacists
employed in the pharmaceutical or allied industries of the Member States of the European Union,
the European Economic Area, or European countries having a mutual recognition agreement
with the European Union on compliance control of regulated medicines."