This topic was endorsed by the ICH Assembly in June 2023.
Further to the ICH Management Committee’s endorsement of the E22 Concept Paper in June 2024, the E22 Guideline aims to optimise the use of patient preference information as input to pharmaceutical product development using a globally harmonised framework and allow regulatory authorities and the pharmaceutical industry to benefit from harmonised approaches for PPS throughout drug development including, where applicable, submission to different regulatory agencies.
