RAPS published this news on 26 June 2026. ICH E22 was released in November 2025. The guideline covers patient preference studies in drug development. It recommends placing PPS evidence in CTD modules 2 and 5. European groups asked for clearer rules on caregivers, regions, and digital tools.
ICH E22 Main Topic
ICH E22 explains how patient preference studies can support drug development, benefit-risk assessment, and regulatory submissions. The guideline covers the use, design, analysis, and submission of PPS evidence. One key technical point is CTD placement: RAPS reports that PPS evidence should be included in modules 2 and 5, making it relevant for regulatory writers and submission teams.
RA, Clinical, and Benefit-Risk Impact
For regulatory affairs, clinical development, and benefit-risk teams, the positive impact is stronger patient-centered evidence in submissions. PPS data can help explain risk tolerance, treatment burden, and patient priorities. The negative side is uncertainty around global applicability, local healthcare differences, reimbursement context, and study transferability. European commenters also asked for clearer guidance on caregiver input, digital platforms, and qualitative versus quantitative methods.
Career Signals for Patient-Centric Roles
This topic matters for RA specialists, clinical research teams, medical affairs professionals, and immigrant pharmacists because patient-centered evidence is becoming more technical. Candidates who understand ICH E22, PPS, CTD, benefit-risk assessment, EMA comments, and patient engagement can stand out in EU-facing roles.
RA Strategy Teams
RA teams should understand how PPS evidence supports CTD structure, benefit-risk narratives, labeling discussions, and regional regulatory questions across ICH regions.
- Map PPS evidence to CTD modules.
- Prepare region-specific justification early.
Clinical Development Teams
Clinical teams may need stronger PPS protocol design, patient recruitment logic, caregiver input planning, and digital data-capture methods for future studies.
- Separate qualitative and quantitative PPS methods.
- Include patient-facing materials early.
Immigrant Pharmacist Pathways
Immigrant pharmacists and job seekers can use ICH E22 to learn modern EU regulatory language and connect pharmacy knowledge with patient-centered evidence roles.
- Learn PPS and benefit-risk vocabulary.
- Mention CTD awareness in interviews.
PPS Evidence Outlook
The result could be stronger expectations for patient preference evidence in 2026 regulatory work. European feedback highlights practical gaps: caregiver input, local-region definitions, digital platforms, patient protocol input, and decision-use examples. This may increase demand for RA, clinical operations, regulatory writing, medical affairs, and patient engagement professionals.
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