ICH Guidelines—Implementation of the 3Rs (Refinement, Reduction, and Replacement): Incorporating Best Scientific Practices into the Regulatory Process (PDF)
Safety Guidelines
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF)
M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (PDF)
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use – M4S: The CTD - Safety
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use – M4S: The CTD - Safety Appendices
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (PDF)
S1B Testing for Carcinogenicity of Pharmaceuticals (PDF)
S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF)
S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes (PDF)
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (PDF)
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (PDF)
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF)
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF)
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (PDF)
S5A Detection of Toxicity to Reproduction for Medicinal Products (PDF)
S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility (PDF)
S7A Safety Pharmacology Studies for Human Pharmaceuticals
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
S8 Immunotoxicity Studies for Human Pharmaceuticals
