EMA assesses parallel scientific advice program

In a report evaluating the pilot program in which EMA is providing parallel scientific advice with health technology assessment (HTA) organizations, EMA said regulators and HTA groups are reaching "a high level of alignment," and uptake of the program is increasing.

EMA began the pilot program in 2010 to assist drug developers in meeting data requirements of both EMA regulators and HTA bodies, such as the U.K.'s NICE and Germany's Institute for Quality and Efficiency in Health Care (IQWiG). In Thursday's report, EMA said that among 31 parallel advice procedures it analyzed, about 70% of sponsors could satisfy the evidence needs of both regulators and HTA organizations through a single clinical trial design or development program. ...