Swissmedic offers Scientific Advice for Weight-of-Evidence Approach described in the Addendum of ICH Guideline S1B(R1)


As described in the Addendum of ICH S1B(R1), applicants are advised to provide a thorough integrated Weight-of-Evidence (WoE) approach on the need for a 2-year rat carcinogenicity study. Swissmedic encourages applicants to seek regulatory feedback when the WoE assessment supports a conclusion that conduct of a 2-year rat study does not add value to the assessment of human carcinogenic risk.
At Swissmedic, such consultation is provided as Scientific Advice. As described in the relevant Guidance document “Meeting for applicants held with the Authorisation sector”, adequate documentation, which addresses all aspects of the WoE approach (see section 2.1 of the Addendum of ICH S1B(R1)), should be submitted with the request for Scientific Advice.

Swissmedic will conduct an evaluation of the submitted documentation and provide feedback on the need to perform carcinogenicity studies within 4-8 weeks. Swissmedic reserves the right to request further information from the applicant.

Scientific advice is not legally binding. The final assessment on the need of a 2-year rat carcinogenicity study will be made as part of the assessment of the marketing authorisation application once the full data package is available.