Drugs

International Council for Harmonisation - Safety

Below is a sortable list of the International Council on Harmonisation - Safety Guidance Documents. You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

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

CategoryTitleTypeDate
International Council on Harmonisation - Safety S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (PDF - 100KB) Final Guidance 03/01/96
International Council on Harmonisation - Safety S1B Testing for Carcinogenicity of Pharmaceuticals (PDF - 145KB) Final Guidance 02/28/98
International Council on Harmonisation - Safety S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF - 185KB) Final Guidance 09/17/08
International Council on Harmonisation - Safety S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF - 123KB) Final Guidance 04/01/96
International Council on Harmonisation - Safety S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF - 131KB) Final Guidance 11/21/97
International Council on Harmonisation - Safety S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF - 427KB) Final Guidance 06/06/12
International Council on Harmonisation - Safety S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF - 46KB) Final Guidance 03/01/95
International Council on Harmonisation - Safety S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF - 14KB) Final Guidance 03/01/95
International Council on Harmonisation - Safety S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (PDF - 21KB) Final Guidance 06/25/99
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 09/01/94
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 04/01/96
International Council on Harmonisation - Safety S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (July 2011) See Attachment Final Guidance 05/17/12
International Council on Harmonisation - Safety S7A Safety Pharmacology Studies for Human Pharmaceuticals (PDF - 44KB) Final Guidance 07/01/01
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 10/19/05
International Council on Harmonisation - Safety S8 Immunotoxicity Studies for Human Pharmaceuticals (PDF - 72KB) Final Guidance 04/12/06
International Council on Harmonisation - Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 169KB) Final Guidance 03/05/10
International Council on Harmonisation - Safety S10 Photosafety Evaluation of Pharmaceuticals (PDF - 256KB) Final Guidance 01/26/15
International Council for Harmonisation - Safety S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic (PDF - 181KB) Draft Guidance 09/08/16
International Council for Harmonisation - Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers (PDF - 190KB) Draft Guidance 09/16/16

Page Last Updated: 09/20/2016
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