Swissmedic launches the public consultation on Guideline E22 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 12 April 2026 for comments.
Public consultation on ICH Guideline E22 “General Considerations for Patient Preference Studies” launched in Switzerland
22.12.2025
Stakeholders in Switzerland are invited to submit comments by 12 April 2026 on the draft Guideline E22 “General Considerations for Patient Preference Studies”.
The integration of patient perspectives has become increasingly systematic across all stages of drug development, ensuring that decisions and benefit-risk assessments are better aligned with patients’ values and needs. Patient Preference Studies (PPS) include any qualitative or quantitative assessment of the relative desirability or acceptability to patients of aspects that differ among alternative health interventions. PPS can add to the body of evidence and supplement clinical trial data when assessing benefit-risk; they can help with characterisation of medical need, endpoint selection and identify subgroups with different preferences.
ICH Guideline E22 will cover one of the proposed initiatives in the ICH Patient-focused Drug Development Reflection Paper (2021), which identified the need for harmonised guidance on general considerations for the design and conduct of PPS to inform pharmaceutical product development and promote consistency in regulatory submissions.
This new ICH guideline will provide high level principles and practical guidance for:
- Describing situations where PPS could be informative to pharmaceutical product development;
- Study design and methodological considerations;
- Study documentation;
- Operational aspects and additional considerations.
Comments can be provided to networking@swissmedic.ch using the feedback form specified by ICH. Stakeholders will receive confirmation of receipt of their comments, but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working groups and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page: