EMA responds to IQWiG criticism of adaptive pathway

In a response to criticism by Germany's Institute for Quality and Efficiency in Health Care, EMA said the now-completed pilot program of its adaptive licensing pathway was "intended to be a learning exercise" about the use of real-world data, one of the pathway's key components.

The adaptive pathway is designed to bring drugs to market through iterative phases of evidence gathering and licensing, with further approval or adjustments based on postmarket trials and real-world evidence (see BioCentury, July 18, 2014). ...