Q1A（R2） 新原料药和制剂的稳定性试验 1
Q1B 稳定性试验：新原料药和制剂的光稳定性试验 27
Q1C 新剂型的稳定性试验 38
Q1D 新原料药和制剂稳定性试验的括号设计法和矩阵设计法 41
Q1E 稳定性数据的评价 52
Q1F 气候带Ⅲ和Ⅳ注册用稳定性数据 73
Q2A 分析方法论证的文本 80
Q2B 分析方法的论证：方法学 87
Q3A（R） 新原料药中的杂质 99
Q3B（R） 新药制剂中的杂质 112
Q3C 杂质：残留溶剂的指导原则 126
Q3C（M） 杂质：残留溶剂（修订）N-甲基吡咯烷酮（NMP）的日允许接触剂量（PDE） 145
Q3C（M） 杂质：残留溶剂（修订）四氢呋喃的日允许接触剂量PDE 149
Q5A 生物技术产品的病毒安全性评价 152
Q5B 对用于生产rDNA来源蛋白质产品的细胞的表达构建体分析 184
Q5C 生物技术产品质量：生物技术／生物制品稳定性试验 191
Q5D 用于生物技术／生物制品生产的细胞基质的来源和鉴定 205
Q5E 生物技术产品／生物制品在生产工艺变更前后的可比性 221
Q6A 规范：新原料药和新药制剂的测试方法和认可标准：化学物质 238
Q6B 质量标准：生物技术产品及生物制品的测试方法和认可标准 277
Q7A 活性药物成分（API）的GMP指南 298
Q8 药品研发 354
Q9 质量风险管理 364
Q1A(R2) STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS 388
Q1B STABILITY TESTING:PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS 424
Q1C STABILITY TESTING FOR NEW DOSAGE FORMS Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products 439
Q1D BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS 443
Q1E EVALUATION FOR STABILITY DATA 456
Q1F STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES Ⅲ AND Ⅳ 486
Q2A TEXT ON VALIDATION OF ANALYTICAL PROCEDURES 494
Q2B VALIDATION OF ANALYTICAL PROCEDURES:METHODOLOGY 503
Q3A(R) IMPURITIES IN NEW DRUG SUBSTANCES 519
Q3B(R) IMPURITIES IN NEW DRUG PRODUCTS 537
Q3C IMPURITIES:GUIDELINE FOR RESIDUAL SOLVENTS 557
Q3C(M) IMPURITIES:RESIDUAL SOLVENTS(MAINTENANCE)PDE FOR N-METHYLPYRROLIDONE(NMP) 582
Q3C(M) IMPURITIES:RESIDUAL SOLVENTS(MAINTENANCE)PDE FOR TETRAHYDROFURAN 586
Q5A VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN 590
Q5B QUALITY OF BIOTECHNOLOGICAL PRODUCTS:ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS 637
Q5C QUALITY OF BIOTECHNOLOGICAL PRODUCTS:STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS 647
Q5D DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS 666
Q5E COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS 692
Q6A SPECIFICATIONS:TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:CHEMICAL SUBSTANCES 717
Q6B SPECIFICATIONS:TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS 770
Q7A GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS 803
Q8 PHARMACEUTICAL DEVELOPMENT 886
Q9 QUALITY RISK MANAGEMENT 902