Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
ICH S1B(R1) guideline was published in August 2022 after over 10 years of international joint prospective study. In the addendum, added as Part II of this revised guideline, a comprehensive approach based on a weight of evidence (WoE) is introduced to determine whether conducting a 2-year rat carcinogenicity study is considered to add value to human carcinogenicity risk assessment. Thus, it opens the way to assess carcinogenicity risk to humans without conducting a 2-year rat carcinogenicity study. This addendum applies to all pharmaceuticals requiring carcinogenicity studies, and for the value judgement of 2-year rat carcinogenicity test on human carcinogenicity risk assessment, 1) target biology, 2) secondary pharmacology, 3) histopathological data from chronic studies, 4) hormonal effects, 5) genotoxicity, and 6) immune modulation as major factors should be considered, with potential investigative approaches including non-clinical and clinical data approaches to further inform concerns identified by WoE.
In the United States, it was issued on November 2, 2022. In Japan, a notification was issued by the Ministry of Health, Labor and Welfare on March 10, 2023. In Europe, it was implemented on March 16, 2023 at about the same time, and carcinogenicity evaluation based on this addendum has started domestically and internationally.
It has been about one year since this addendum was established and about three months since it has been implemented in the three regions. It is considered necessary to reorganize the main points of the addendum and to share information on the implementation status of evaluations based on the WoE approach. In this symposium, we would like to provide information on the main points of S1B(R1), the actual implementation status, and points for future application, and take this as an opportunity to discuss appropriate use.
