ICHPharmaceutical Regulations in Japan

Genotoxicity test Q&A 2014 (revision)

“Genotoxicity test Q&A 2014 (revision)” is issued by Non-Clinical Evaluation Expert Committee of Drug Evaluation Committee in JPMA.
This revised version amends that 3 types of mammalian cell assays (in vitro chromosome aberration test, in vitro micronucleus test and mouse lymphoma assay) are equally acceptable for the genotoxic assessment of antimicrobial drugs, in accordance with the current ICH S2 (R1) genotoxicity guideline.

A series of “Genotoxicity test Q&A” has been voluntarily issued by JPMA with the intention of offering a practical example to lab-scientists every time when a guideline for genotoxicity test for pharmaceuticals was notified /revised in Japan.
Early versions had been published as a book but this time we decided that the Q&A materials are disclosed on the JPMA ICH website to be used readily. These Q&A materials explained about how to deal with the guideline however the contents are limited to items that were changed or added in the latest guideline. Therefore, we recommend referring to the previous book titled “Q&A on Genotoxicity testing for Pharmaceuticals” (Scientist Inc., Tokyo, 2000). We hope the Q&A books and materials help the lab-scientists solve the problems to be faced in routine works.

Working Language: Japanese
Simultaneous English-Japanese Translation: Not Available

Genotoxicity test Q&A 2014(revision) (PDF 1041KB)

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