EMA, EUnetHTA look to collaboration's future
EMA and the European network for Health Technology Assessment (EUnetHTA) said they will continue to collaborate and listed future areas for cooperation in a report summarizing the results of a three-year work plan that guided their collaboration through December 2015. The groups are working together to clarify the data needs of regulators and HTA bodies so that drug sponsors can satisfy both with a single development program.
The groups said they hope to engage in more structured interactions surrounding MAAs, including presubmission dialogue; improve regulatory reports, in part by adding patient-reported outcomes, to guide HTAs for reimbursement; and develop guidelines on the design of clinical development programs for specific conditions. ...