The Institute for Quality and Efficiency in Health Care (IQWiG) is calling for international reforms to the drug development and approval cycles, FiercePharma reports.
According to the report, the agency found that only 25 percent (54) of 216 approvals between 2011 and 2017 delivered major health benefits over standard care.
“We believe that regulators should become far less tolerant of shortened drug development programs,” the agency said. “Restoring their previous policy, they should demand robust evidence from longer-term and sufficiently large phase 3 randomized controlled trials to prove efficacy and safety, which in parallel could be used to collect data for health technology assessment.”
To read the full report on Fierce Pharma, click here.