Posted by Michael Wonder on 14 Jun 2018
Building synergy between regulatory and HTA agencies beyond processes and procedures—can we effectively align the evidentiary requirements? A survey of stakeholder perceptions
13 June 2018 - The pathway for bringing a new medicine to the market is dependent on two sequential processes: achieving market authorisation from the regulatory agency and reimbursement from a payer.
Wang et al. set out to evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy.
Two separate questionnaires were developed to assess stakeholders’ perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies.
