ICH指南目录

ICH指南目录

ICH：Quality质量

彭姓男孩取名 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，更生霉素 药物注册申请所提供的稳定性数据 Q2A: Text 显示器校色

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 (Revid Guideline) 新原料药中的

杂质（修订版）

Q3B(R): Impurities in New Drug Products (Revid 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希斯克利夫 估

Q5B: Quality of Biotechnological Products: Analysis of the Expression

Construct in Cells Ud

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 Ud 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: Do 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 Do 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 Asssment 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 Do 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 Do 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 Asss 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 Ca 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国庆作文

Transmission of Individual Ca 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: Do-Respon 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 ction for complete Status of

the guidelines) 通用技术文件（见有关九里香花语 CTD章节）

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

标准

感谢您的阅读，祝您生活愉快。