S1A 药物致癌试验必要性的指导原则 1
S1B 药物致癌试验 8
S1C（R） 药物致癌试验的剂量选择和剂量限度 19
S2A 药物审评遗传毒性试验的特殊性指导原则 31
S2B 遗传毒性：药物遗传毒性试验标准组合 45
S3A 毒物代谢动力学（毒代动力学）指导原则：毒性研究中全身暴露的评价 56
S3B 药物代谢动力学（药代动力学）：重复给药的组织分布研究指导原则 71
S4 动物（啮齿类和非啮齿类）慢性毒性试验的期限 75
S5（R2） 药品的生殖毒性检测和雄性生育力毒性 78
S5B 雄性生育力毒性ICH指导原则 103
S6 生物技术药物的临床前安全性评价 109
S7A 人用药物安全药理学研究指导原则 123
S7B 人用药延迟心室复极化（QT间期延长）潜在作用的非临床评价指导原则 137
S8 人用药物免疫毒性研究 151
M3（R1） 支持药物进行临床试验的非临床安全性研究 166
S1A GUIDELINE ON THE NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS 178
S1B TESTING FOR CARCINOGENICITY OF PHARMA-CEUTICALS 188
S1C(R1) DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS ＆ LIMIT DOSE 204
S2A GUIDANCE ON SPECIFIC ASPECTS OF REGULATORY GENOTOXICITY TESTS FOR PHARMACEUTICALS 224
S2B GENOTOXICITY:A STANDARD BATTERY FOR GENOTOXICITY TESTING OF PHARMACEUTICALS 248
S3A NOTE FOR GUIDANCE ON TOXICOKINETICS:THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES 265
S3B PHARMACOKINETICS:GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES 288
S4 DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NON RODENT TOXICITY TESTING) 294
S5(R2) DETECTION OF TOXICITY TO REPRODUCTION FOR MEDICINAL PRODUCTS ＆ TOXICITY TO MALE FERTILITY 299
PART Ⅰ:DETECTION OF TOXICITY TO REPRODUCTION FOR MEDICINAL PRODUCTS 303
PART Ⅱ:TOXICITY TO MALE FERTILITY 332
S6 PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS 339
S7A SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS 360
S7B THE NON-CLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION(QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS 380
S8 IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS 399
M3(R1) MAINTENANCE OF THE ICH GUIDELINE ON NON-CLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS FOR PHARMACEUTICALS 421