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  1. Guidance, Compliance, & Regulatory Information

International Council for Harmonisation - Safety

International Council for Harmonisation - Safety

The International Conference on Harmonisation has changed its name to International Council for Harmonisation 

Category Title Type Date
International Council on Harmonisation - Safety The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 100KB) Final Guidance 3/1/1996
International Council on Harmonisation - Safety S1B Testing for Carcinogenicity of Pharmaceuticals (PDF - 145KB) Final Guidance 2/28/1998
International Council on Harmonisation - Safety S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF - 185KB) Final Guidance 9/17/2008
International Council on Harmonisation - Safety S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF - 123KB) Final Guidance 4/1/1996
International Council on Harmonisation - Safety S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF - 131KB) Final Guidance 11/21/1997
International Council on Harmonisation - Safety S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF - 427KB) Final Guidance 6/6/2012
International Council on Harmonisation - Safety S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF - 46KB) Final Guidance 3/1/1995
International Council on Harmonisation - Safety S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF - 14KB) Final Guidance 3/1/1995
International Council on Harmonisation - Safety S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (PDF - 21KB) Final Guidance 6/25/1999
International Council on Harmonisation - Safety S5A Detection of Toxicity to Reproduction for Medicinal Products S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised. (PDF - 87KB) Final Guidance 9/1/1994
International Council on Harmonisation - Safety S5B Detection of Toxicity to Reproduction for Medicinal Products: S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised. (PDF - 98KB) Final Guidance 4/1/1996
International Council on Harmonisation - Safety S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (July 2011) See Attachment Final Guidance 5/17/2012
International Council on Harmonisation - Safety S7A Safety Pharmacology Studies for Human Pharmaceuticals (PDF - 44KB) Final Guidance 7/1/2001
International Council on Harmonisation - Safety S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (PDF - 52KB) Final Guidance 10/19/2005
International Council on Harmonisation - Safety S8 Immunotoxicity Studies for Human Pharmaceuticals (PDF - 72KB) Final Guidance 4/12/2006
International Council on Harmonisation - Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 169KB) Final Guidance 3/5/2010
International Council on Harmonisation - Safety S10 Photosafety Evaluation of Pharmaceuticals (PDF - 256KB) Final Guidance 1/26/2015
International Council for Harmonisation - Safety S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling (PDF - 149KB) Final Guidance 5/9/2018
International Council for Harmonisation - Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers (PDF - 536KB) Final Guidance 6/15/2018
International Council for Harmonisation - Safety S5(R3) Detection of Toxicity to Reproduction (PDF - 1.4MB) Draft Guidance 11/9/2017