This Reflection Paper was endorsed by the Assembly in June 2018.

This ICH Reflection Paper outlines a strategic approach to enhance the portfolio of ICH Quality-related guidelines to support continual improvement and innovation in biopharmaceutical manufacturing technologies and approaches. Accordingly, ICH will continue to advance the ICH Quality Vision to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasising an integrated approach to quality risk management and science”.

This ICH Reflection Paper furthermore describes, in the annex, the remit of the Quality Discussion Group (QDG), which serves as a technical discussion forum for issues relevant to the ICH Quality Vision.