Regulators Publish Guidance for Industry, Non Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization.
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The purpose of this document is to recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.
This is a revision of the ICH guidance “M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals” that published in 1997. The revisions further harmonize recommendations in a number of areas and include a new section on exploratory clinical studies. This revised guidance discusses other nonclinical studies that should be conducted on a case-by-case basis as appropriate, including phototoxicity studies, immunotoxicity studies, juvenile animal toxicity studies, and abuse potential studies.
This guidance should facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3R (reduce/refine/replace) principles, and reduce the use of other drug development resources. Although not discussed in this guidance, consideration should be given to use of new in vitro alternative methods for safety evaluation. These methods, if validated and accepted by all ICH regulatory authorities, can be used to replace current standard methods. This guidance promotes safe, ethical development and availability of new pharmaceuticals.
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