ICH Project ICH S1B (R1) Guideline Workshops
November 28, 2023
The ICH S1B(R1) Guidelines reached Step 4 on August 4, 2022, based on the discussions in the ICH S1B(R1) Expert Working Group, and "Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals" including the revision of the ICH S1B(R1) Guidelines was issued in Japan on March 10, 2023. The revision of the guideline 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.