Global regulators look to integrate real-world evidence into regulatory decision-making

The International Coalition of Medicines Regulatory Authorities is calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making, with harmonization of real-world data and RWE terminologies, convergence of RWD and RWE guidance, and best practice, readiness and transparency key areas of focus. 

ICMRA’s joint statement, released Monday, follows a workshop last month in Amsterdam on RWE co-chaired by EMA, FDA and Health Canada.  ...