EMA, EUnetHTA outline priorities in work plan

EMA and the European network for Health Technology Assessment (EUnetHTA) said they will focus on generating data to support decision making by both regulators and health technology assessment (HTA) organizations. In a work plan, the parties outlined areas of focus for their collaboration through 2015, including working to develop guidelines for clinical trial designs that can generate data for both benefit-risk and relative effectiveness assessments as well as developing approaches to collect data post-approval that support both regulators and HTA bodies.

On Tuesday, EMA is hosting a one-day workshop on parallel scientific advice from the agency and HTA bodies on generating evidence during drug development. ...