ICH 系列指导原则

ICH：Quality质量

Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)新原料药和制剂的稳定性试验（第二版）

Q1B: Photostability Testing of New Drug Substances and Products 新原料药和制剂的光稳定性试验

Q1C: Stability Testing for New Dosage Forms 新制剂的稳定性试验

Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

原料药和制剂稳定性试验的交叉和矩阵设计 Q1E: Evaluation of Stability Data 对稳定性数据的评估处理

Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV

在气候带III和IV，药物注册申请所提供的稳定性数据 Q2A: Text on Validation of Analytical Procedures 分析程序的验证

Q2B: Validation of Analytical Procedures: Methodology 分析程序的验证：方法学

Q3A(R): Impurities in New Drug Substances (Revised Guideline) 新原料药中的杂质（修订版）

Q3B(R): Impurities in New Drug Products (Revised Guideline) 新制剂中的杂质（修订版）

Q3C: Impurities: Guideline for Residual Solvents 杂质：残留溶剂指南

Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance) 杂质：残留溶剂指南（修改内容） Q4: Pharmacopoeias药典

Q4A: Pharmacopoeial Harmonisation 药典的协调

Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability 药典互替在法规上的可接受性

Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

来源于人或者动物细胞系的生物技术产品的病毒安全性评估

Q5B: 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：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析

Q5C:Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products

生物技术产品的质量：生物技术/生物产品的稳定性试验

Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

用于生产生物技术/生物产品的细胞底物的起源和特征描述

Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

基于不同生产工艺的生物技术产品/生物产品的可比较性 Q6: Specifications for New Drug Substances and Products 新原料药和制剂的质量规格

Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质 Q6B:

Specifications:

Test

Procedures

and

Acceptance

Criteria

for

Biotechnological/Biological Products

质量规格：生物技术/生物产品的检验程序和可接收标准 Q7: Good Manufacturing Practices for Pharmaceutical Ingredients 活性药物成份的GMP

Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

活性药物成份的GMP指南 Q8: Pharmaceutical Development 药物研发

Q9: Quality Risk Management 质量风险管理 ICH：Safety安全

S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals 药物致癌性研究需要的指南

S1B: Testing for Carcinogenicity of Pharmaceuticals 药物致癌性的检验

S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals 药物致癌性研究之剂量选择

S1C(R): Addendum: Addition of a Limit Dose and Related Notes 附录：极限剂量和有关注释的的补充

S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

受法规管辖的药物基因毒性检验的特定方面的指南

S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性：药物基因毒性检验的标准

S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估

S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 药物代谢动力学：重复剂量的组织分布研究指南 S4: Single Dose Toxicity Tests 单剂量毒性检验

S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)

动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验） S5A: Detection of Toxicity to Reproduction for Medicinal Products

药物对生殖发育的毒性的检验

S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products

对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录

S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 生物技术生产的药物的临床前安全评价

S7A: Safety Pharmacology Studies for Human Pharmaceuticals 人用药的安全药理学研究

S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization

(QT Interval Prolongation) By Human Pharmaceuticals 药物延迟心室复极化（QT间期）潜在作用的非临床评价 S8: Immunotoxicology Studies for Human Pharmaceuticals 人用药免疫毒理学研究

M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals 药物的对人临床试验的非临床安全研究指南的变动

E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions

对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围 E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

临床安全数据管理：速报制度的定义和标准

E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports

个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版 E2B (M): Maintenance of the Clinical Safety Data Management including: Data

Elements for Transmission of Individual Case Safety Reports 临床安全数据管理的变动包括：个案安全报告送交的数据要素

E2B(M): Maintenance of the Clinical Safety Data Management including Questions and Answers

临床安全数据管理的变动，包括问答

E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

临床安全数据管理：已上市药品的周期性安全数据更新报告 Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs E2C的附录：已上市药品的周期性安全数据更新报告

E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

批准后的安全数据管理：速报制度的定义和标准 E2E: Pharmacovigilance Planning 药物警戒计划

E3: Structure and Content of Clinical Study Reports 临床研究报告的结构和内容

E4: Dose-Response Information to Support Drug Registration 支持药品注册的剂量－效应资料

E5: Ethnic Factors in the Acceptability of Foreign Clinical Data 引入海外临床数据时要考虑的人种因素 E6: Good Clinical Practice: Consolidated Guideline GCP：良好的临床规范：统一的指南

E7: Studies in Support of Special Populations: Geriatrics 对特定族群的支持的研究：老人病学 E8: General Considerations for Clinical Trials 对临床试验的总的考虑

E9: Statistical Principles for Clinical Trials 临床试验的统计原则

E10: Choice of Control Group and Related Issues in Clinical Trials

临床试验中控制组和有关课题的选择

E11: Clinical Investigation of Medicinal Products in the Pediatric Population 小儿科药物的临床调查

E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs 新抗高血压药物的临床评价原则

E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价 Multidisciplinary Guidelines 多学科兼容的指南 M1: Medical Terminology 医学术语

M2: Electronic Standards for Transmission of Regulatory Information (ESTRI) 药政信息传递之电子标准

M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics) 有关临床试验的临床前研究的时间安排

M4: The Common Technical Document (See CTD section for complete Status of the guidelines)

通用技术文件（见有关CTD章节）

M5: Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准

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