Global regulators look to integrate real-world evidence into regulatory decision-making
Regulators from 13 countries agree to harmonize RWE use
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. ...