ICH Publishes Draft Guidelines on Patient Preferences, RWE, and Biosimilars

The International Council for Harmonisation (ICH) has released the E22 Draft Guideline on General Considerations for Patient Preference Studies for public consultation until 12 April 2026 in Europe. These studies capture what matters most to patients—such as effectiveness, side effects, safety, and convenience—helping developers and regulators consider patient perspectives in drug development. The draft outlines key principles, study types, and practical guidance for designing and conducting patient preference studies.

Following the final M14 Guideline on real-world data (RWD) for safety assessment, ICH published a concept paper for a new E23 Guideline on the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making, focusing on treatment effectiveness across a medicine’s lifecycle.

Additionally, ICH shared a concept paper for M18, Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs. More details are available on the ICH website under Efficacy Guidelines.

20-01-2026