22. September 2023 – As described in the Addendum of the S1B(R1) guideline for carcinogenicity of pharmaceuticals of the ICH, applicants are advised to provide a thorough integrated Weight-of-Evidence approach regarding the necessity for a 2-year rat carcinogenicity study. Swissmedic encourages applicants to seek regulatory feedback when the Weight-of-Evidence assessment supports a conclusion that conduct of a 2-year rat study does not add value to the assessment of human carcinogenic risk.

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