Commonality in evidentiary requirements across regulatory and HTA stakeholders


Workshop objectives

  • Discuss the progress made to align evidentiary requirements, what the drivers have been and if this has improved the efficiency and effectiveness of the development, approval and reimbursement processes.
  • Identify the areas where there are still major differences that impede efficient and non-divergent regulatory and HTA decision making.
  • Make further concrete recommendations as to how to ensure complementary evidence generation and what is needed to mitigate the risk of mismatch of outcomes that can occur when a regulatory authority grants an approval that is not compatible with current HTA decision-making requirements.