ICH Project ICH S1B (R1) Guideline Workshops
November 28, 2023
The ICH S1B(R1) Guideline reached Step 4 on August 4, 2022 based on the study by the ICH S1B(R1) Expert Working Group, and in Japan, "Revision of Guidelines for Carcinogenicity Studies of Drugs" including the revision of the ICH S1B(R1) Guideline was
published in March2023. The "Revision of Guidelines for Carcinogenicity Studies of Pharmaceuticals" was issued as a notice on March 10, 2023, and has reached Step 5 in Japan.
In order to promote understanding of this guideline, ICH S1B (R1) Guideline Workshops were recently held.
The program and other details of the briefing can be found on the PMDA Website.