A report by the European Medicines Agency (EMA) on its pilot on parallel scientific advice with health technology assessment (HTA) bodies is now available.
This initiative was set up to allow sponsors to receive simultaneous feedback on their development plans from both regulators and HTA bodies. Since data generated during clinical trials is appropriate for regulators and HTA bodies, simultaneous feedback can lead to fewer delays in access to medicines for patients. According to EMA, there is a “high level of alignment between the requirements of regulators and HTA bodies was achieved with the parallel scientific advice procedure.”
Thus EMA has stated “parallel scientific advice with HTA bodies and other relevant stakeholders is now routinely offered as part of the Agency’s scientific advice activities.”
OrphaNews April 19, 2016
Read the report