Positive early dialogue with regulators and HTA bodies reported by EMA

The European Medicines Agency (EMA) has published today a report on its pilot on parallel scientific advice with health-technology-assessment (HTA) bodies that finished at the end of March 2016. This initiative that allows developers of new medicines to receive simultaneous feedback on their development plans from both regulators and HTA bodies is being continued.

Since its start in July 2010, a total of 63 parallel scientific advice procedures were completed by December 2015. 14 applications for the parallel scientific advice procedure are currently registered for 2016 (four are ongoing, two are completed and eight are due to start). Take up of parallel scientific advice increased significantly, as the number of procedures almost tripled in 2015 compared to the previous year.

The report also indicates that a high level of alignment between the requirements of regulators and HTA bodies was achieved with the parallel scientific advice procedure. An analysis of a subset of 31 parallel scientific advice procedures completed between the start of the pilot and May 2015 showed that in around 70% of cases, one clinical trial design or one development program could satisfy the evidence needs of regulators and HTA bodies.