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# ICH Guidance on Nonclinical Studies for Anticancer Agents
- URL: https://www.fdaweb.com/ich-guidance-on-nonclinical-studies-for-anticancer-agents/
- Published: 2016-09-16T12:00:00.000Z
- Updated: 2026-09-14T21:32:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136827

FDA has posted an International Conference on Harmonization [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM520942.pdf?ref=fdaweb.com) on “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers” that is intended to help sponsors implement the S9 Guideline to reduce/replace the use of animals in preclinical studies. For example, where a therapeutic increases survival, “no additional general toxicology studies are usually warranted,” the guidance says. “The clinical safety data in the intended population is more relevant to assess human risks than those generated in additional animal studies. Toxicology studies other than general toxicology may be needed on a case-by-case basis. If additional studies are important, such studies could be available post-approval.”