| Q1A(R2) | Step 5 | Stability Testing of New Drug Substances and Products
新原料药和制剂的稳定性试验 |
| Q1B | Step 5 | Stability Testing : Photostability Testing of New Drug Substances and Products
稳定性试验：新原料药和制剂的光稳定性试验 |
| Q1C | Step 5 | Stability Testing for New Dosage Forms
稳定性试验：新剂型的要求 |
| Q1D | Step 5 | Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
新原料药和制剂稳定性试验的括号法和矩阵法设计 |
| Q1E | Step 5 | Evaluation of Stability Data
稳定性数据的评价 |
| Q1F | 废止 | Stability Data Package for Registration Applications in Climatic Zones III and IV
气候带III和IV注册申请的稳定性数据包 |
| Q2(R1) | Step 5 | Validation of Analytical Procedures: Text and Methodology
分析方法验证：文本及方法学 |
| Q3A(R2) | Step 5 | Impurities in New Drug Substances
新原料药中的杂质 |
| Q3B(R2) | Step 5 | Impurities in New Drug Products
新药制剂中的杂质 |
| Q3C(R6) | Step 5 | Impurities: Guideline for Residual Solvents
杂质：残留溶剂指南 |
| Q3D | Step 5 | Guideline for Elemental Impurities
元素杂质指南 |
| Q4 | | Pharmacopoeias
药典 |
| Q4A | | Pharmacopoeial Harmonisation
药典的同一化 |
| Q4B | Step 5 | Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH各地区使用的药典正文评估和建议 |
| Q4B Annex 1 (R1) | Step 5 | Residue on Ignition/Sulphated Ash General Chapter
关于ICH区域内药典附录的评价及建议-炽灼残渣（硫酸灰分）检查法 |
| Q4B Annex 2 (R1) | Step 5 | Test for Extractable Volume of Parenteral Preparations General Chapter
关于ICH区域内药典附录的评价及建议-注射剂装量检查法 |
| Q4B Annex 3 (R1) | Step 5 | Test for Particulate Contamination: Sub-Visible Particles General Chapter
关于ICH区域内药典附录的评价及建议-不溶性微粒检查法 |
| Q4B Annex 4A (R1) | Step 5 | Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：微生物计数法 |
| Q4B Annex 4B (R1) | Step 5 | Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：控制菌检查法 |
| Q4B Annex 4C (R1) | Step 5 | Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：原料药及其制剂的判定标准 |
| Q4B Annex 5 (R1) | Step 5 | Disintegration Test General Chapter
关于ICH区域内药典附录的评价及建议-崩解时限检查法 |
| Q4B Annex 6 | Step 5 | Uniformity of Dosage Units General Chapter
关于ICH区域内药典附录的评价及建议-含量均匀度检查法 |
| Q4B Annex 7 (R2) | Step 5 | Dissolution Test General Chapter
关于ICH区域内药典附录的评价及建议-溶出度检查法 |
| Q4B Annex 8 (R1) | Step 5 | Sterility Test General Chapter
关于ICH区域内药典附录的评价及建议-无菌检查法 |
| Q4B Annex 9 (R1) | Step 5 | Tablet Friability General Chapter
关于ICH区域内药典附录的评价及建议-片剂脆碎度检查法 |
| Q4B Annex 10 (R1) | Step 5 | Polyacrylamide Gel Electrophoresis General Chapter
关于ICH区域内药典附录的评价及建议-聚丙烯酰胺凝胶电泳法 |
| Q4B Annex 11 | Step 5 | Capillary Electrophoresis General Chapter
关于ICH区域内药典附录的评价及建议-毛细管电泳法 |
| Q4B Annex 12 | Step 5 | Analytical Sieving General Chapter
关于ICH区域内药典附录的评价及建议-筛分法 |
| Q4B Annex 13 | Step 5 | Bulk Density and Tapped Density of Powders General Chapter
关于ICH区域内药典附录的评价及建议-粉末的堆密度和拍实密度测定法 |
| Q4B Annex 14 | Step 5 | Bacterial Endotoxins Test General Chapter
关于ICH区域内药典附录的评价及建议-细菌内毒素检查法 |
| Q5A(R1) | Step 5 | Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
来源于人或动物细胞系的生物技术产品的病毒安全性评价 |
| Q5B | Step 5 | Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
生物技术产品的质量：rDNA衍生蛋白质产品生产细胞的表达构建体分析 |
| Q5C | Step 5 | Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
生物技术产品的质量：生物制品/生物技术产品的稳定性试验 |
| Q5D | Step 5 | Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
用于生物技术产品及生物制品生产的细胞基质的来源和鉴定 |
| Q5E | Step 5 | Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
生物技术产品/生物制品在工艺变更时的可比性 |
| Q6A | Step 5 | Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
质量标准 新原料药和制剂的检测以及可接受标准：化学物质 |
| Q6B | Step 5 | Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
质量标准：生物技术产品以及生物制品的检测方法和可接受标准 |
| Q7 | Step 5 | Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
原料药生产的GMP指南 |
| Q7 Q&As | Step 5 | Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
原料药生产的GMP指南的问与答 |
| Q8(R2) | Step 5 | Pharmaceutical Development
药品研发 |
| Q9 | Step 5 | Quality Risk Management
质量风险管理 |
| Q10 | Step 5 | Pharmaceutical Quality System
药品质量体系 |
| Q8/9/10 Q&As(R4) | Step 5 | Q8/Q9/Q10 Questions and Answers
Q8，Q9，Q10的问与答 |
| Q11 | Step 5 | Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
药物的研发和生产（化学实体和生物技术产品/生物制品实体） |
| Q11 Q&As | Step 3 | Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Q11的问与答 |
| Q12 | Step 1 | Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
药品生命周期的技术和监管考虑 |
