S04-02 Implemetation of ICHS1B addendum: a regulatory point of view

Abstract

Since the revision of ICH S1B has come into effect in 2022, several Weight of Evidence documents have been submitted to regulatory authorities, to establish the risk of a carcinogenic effect of a medicinal product, and the need for a 2-year rat study to further investigate this risk. An overview will be provided, illustrating how many and to which authorities WoE approaches are submitted, and what proportion is accepted or denied. Further an analysis of reasons why such decisions were made is provided. Any discrepancies between regulatory agencies on the decision of accepting or denying the WoE will be presented and discussed further.