Real-World Evidence in Regulatory Decision-Making: Enabling its Use Through International CReal-World Evidence in Regulatory Decision-Making: Enabling its Use Through International Collaboration

To further exploit the full potential of real-world data (RWD) to generate evidence suitable to inform regulatory decision-making, the International Coalition of Medicines Regulatory Authorities (ICMRA) has recently issued a statement calling for international collaboration of medicine regulators. The statement follows a workshop from June 2022, co-organised by EMA, US FDA and Health Canada to discuss the challenges of generating reliable real-world evidence (RWE) from different sources and subject to different governance models. The workshop identified 4 main areas for closer cooperation: harmonization of terminologies; regulatory convergence on guidance and best practice; readiness to address public health challenges and emerging health threats; and transparency. The session will discuss the opportunities for collaboration in these areas to help overcome common challenges and further enable integration of RWE into regulatory decision-making.