The Industry’s Proposal on Revision of Guideline of Toxicological Methods for Mediational Pharmaceuticals

Abstract

Approx. twenty years have passed since the last revision of the “Guidelines for Toxicity Testing of Pharmaceuticals” in Japan. In International Conference on Harmonization (ICH), new guidelines have been issued and some existing guidelines have been revised, but the contents described in the new and the revised guidelines have not been reflected in “Guidelines for Toxicity Testing of Pharmaceuticals”. Therefore, the Non-clinical Evaluation Committee, Drug Evaluation committee, Japan Pharmaceutical manufacturers Association proposes the draft revision that incorporates the contents of the new ICH guidelines, animal welfare issues, and scientific advances, namely the “Guidelines on General Toxicology Studies of Drugs (Proposal)”. The authors wish this manuscript is a trigger for revision of the guideline.