EMA Publishes Parallel Scientific Advice Report

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.   Parallel scientific advice is one of EMA's key initiatives to improve patient access to important new medicines because it ensures that the envisaged clinical trials generate appropriate data for regulators and HTA bodies and allow the assessment of both benefit-risk balance and added value. This can reduce delays between a medicine’s marketing authorization and decisions on reimbursement.   Following the completion of the pilot, parallel scientific advice with HTA bodies and other relevant stakeholders is now routinely offered as part of the Agency’s scientific advice activities.   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 approximately 70% of cases, one clinical trial design or one development programme could satisfy the evidence needs of regulators and HTA bodies.   “Our parallel scientific advice fosters a different, more rational approach to the development of medicines, by bringing together requirements of regulators and HTA bodies in a single development programme,’’ said Professor Guido Rasi, EMA’s Executive Director. “This ensures that patients only participate in well-designed clinical trials that generate the evidence needed for both regulatory and health technology assessment. Ultimately, this will improve timely access by patients to meaningful new medicines across Europe for the benefit of public health.”