1、ICH Guidelines,王震 2015-02-01,ICH Guidelines,说明,ICH的论题主要分为四类，因此ICH根据论题的类别不同而进行相应的编码分类： “Q”类论题：Q代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。 “S”类论题：S代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。 3. “E”类论题：E代表EFFICACY，指那些与人类临床研究相关的课题。 4. “M”类论题：M代表MULTIDISCIPLINARY, 指那些不可单独划入以上三个分类的交叉涉及的论题。同时M又细分为5个小类 M1: 常用医学名词 （MedDRA）
2、M2: 药政信息传递之电子标准 M3: 与临床试验相关的临床前研究时间的安排 M4: 常规技术文件(CTD) M5: 药物词典的数据要素和标准,一、Quality Guidelines 质量研究指导原则,Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach t
3、o pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.,Q1A - Q1F Stability稳定性,Q1A(R2) Stability Testing of New Drug Substances and Products新原料药和制剂的稳定性试验 Q1B Stability Testing : Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验 Q1C Stability Testin
4、g for New Dosage Forms新剂型的稳定性试验 Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and 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稳定性数据的评估 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,Q
5、2 Analytical Validation分析验证,Q2(R1)Validation of Analytical Procedures: Text and Methodology分析程序的验证：正文及方法论,Q3A - Q3D Impurities杂质,Q3A(R2) Impurities in New Drug Substances新原料药中的杂质 Q3B(R2) Impurities in New Drug Products新制剂中的杂质 Q3C(R5) Impurities: Guideline for Residual Solvents杂质：残留溶剂指南 Q3D Guideline
6、 for Elemental Impurities - NEW Q3D Implementation of Guideline for Elemental Impurities,Q4 - Q4B Pharmacopoeias药典,Q4 Pharmacopoeias药典 Q4A Pharmacopoeial Harmonisation药典的协调 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions药典内容的评估及推荐为用于ICH地区 Q4B Annex 1R1 Residue on
7、 Ignition/Sulphated Ash General Chapter附录1 关于灼烧残渣/灰分 常规篇 Q4B Annex 2R1 Test for Extractable Volume of Parenteral Preparations General Chapter关于注射剂可提取容量测试 常规篇 Q4B Annex 3R1 Test for Particulate Contamination: Sub-Visible Particles General Chapter附录3 关于颗粒污染物测试:不溶性微粒 常规篇 Q4B Annex 4AR1 Microbiological
8、Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter,Q4 - Q4B Pharmacopoeias药典,Q4B Annex 4BR1 Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter Q4B Annex 4CR1 Microbiological Examination of Non-Sterile Products: Accep
9、tance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4B Annex 5R1 Disintegration Test General Chapter Q4B Annex 6 Uniformity of Dosage Units General Chapter Q4B Annex 7R2 Dissolution Test General Chapter Q4B Annex 8R1 Sterility Test General Chapter,Q4
10、 - Q4B Pharmacopoeias药典,Q4B Annex 9R1 Tablet Friability General Chapter Q4B Annex 10R1 Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 11 Capillary Electrophoresis General Chapter Q4B Annex 12 Analytical Sieving General Chapter Q4B Annex 13 Bulk Density and Tapped Density of Powders Gen
11、eral Chapter Q4B Annex 14 Bacterial Endotoxins Test General Chapter Q4B FAQs Frequently Asked Questions,Q5A - Q5E Quality of Biotechnological Products 生物技术产品的质量,Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin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 An
12、alysis 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 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
13、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,Q6A- Q6B Specifications规格,Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug S
14、ubstances 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(包括决定过程) 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 Practice (原料药GMP规范),Q7 Good Manufacturing Practice Guide for
15、Active Pharmaceutical Ingredients活性药物成份的GMP指南 Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,Q8 Pharmaceutical Development药物开发,Q8(R2) Pharmaceutical Development药物开发 Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation,Q9 Quality Risk Management 质量风险管理,Q9 Q
16、uality Risk Management Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation,Q10 Pharmaceutical Quality System 药物质量体系,Q10 Pharmaceutical Quality System药物质量体系 Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation实施,Q11 Development and Manufacture of Drug Substances原料药研发与生产,Q11Development and Manufacture of Drug Substances (Ch
17、emical Entities and Biotechnological/Biological Entities) Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances,Q12 Lifecycle Management 生命周期管理,Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
18、,Cross-cutting Topics,Cross-cutting Guidelines,二、Safety Guidelines 安全性评价指导原则,ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT
19、interval prolongation liability: the single most important cause of drug withdrawals in recent years.,S1A - S1C Carcinogenicity Studies致癌性研究,S1 Rodent Carcinogenicity Studies for Human Pharmaceuticals S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmace
20、uticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals,S2 Genotoxicity Studies 遗传毒性研究,S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceutica
21、ls; S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals;,S3A - S3B Toxicokinetics and Pharmacokinetics毒代动力学和药代动力学,S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A Q&AsQuestions and Answers: Note for Guidance on Toxico
22、kinetics: The Assessment of Systemic Exposure - Focus on Microsampling S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies,S4 Toxicity Testing毒性试验,S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing),S5 Reproductive Toxicology 生殖毒理学,S5(
23、R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility,S6 Biotechnological Products 生物技术制品,S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals,S7A - S7B Pharmacology Studies药理学研究,S7A Safety Pharmacology Studies for Human Pharmaceutical
24、s S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals,S8 Immunotoxicology Studies 免疫毒理学研究,S8 Immunotoxicity Studies for Human Pharmaceuticals人类的药物免疫毒性研究,S9 Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药
25、物非临床评价,S9 Nonclinical Evaluation for Anticancer Pharmaceuticals S9 Q&AsQuestions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals,S10 Photosafety Evaluation 光安全评价,S10 Photosafety Evaluation of Pharmaceuticals药物的光安全评价,S11 Nonclinical Safety Testing 非临床安全性试验,S11Nonclinical Safety Tes
26、ting in Support of Development of Paediatric Medicines,Cross-cutting Topics,Cross-cutting GuidelinesSome ICH Products do not fit uniquely into one of the Quality, Safety or Efficacy categories. Those Products can be found under the Mulidisciplinary Section.,三、Efficacy Guidelines 有效性评价指导原则,The work c
27、arried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines,E1 Cli
28、nical Safety for Drugs used in Long-Term Treatment用于长期治疗药物的临床安全性,E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions要评估用于非危及生命的疾病的长期治疗药物的临床安全性人群暴露程度,E2A - E2F Pharmacovigilance 药物警戒,E2A Clinical Safety Data Mana
29、gement: Definitions and Standards for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B(R3) IWGImplementation: Electronic Transmission of Individual Case Safety Reports E2C(R2) Periodic Benefit-Risk Evaluation Report,E2C
30、(R2) -E2F,E2C(R2) Q&AsQuestions & Answers: Periodic Benefit-Risk Evaluation Report E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning E2F Development Safety Update Report,E3 Clinical Study Reports 临床研究报告,E3 Structure and Content
31、 of Clinical Study Reports E3 Q&As R1Questions & Answers: Structure and Content of Clinical Study Reports,E4 Dose-Response Studies 剂量反应研究,E4 Dose-Response Information to Support Drug Registration支持药品注册的剂量反应信息,E5 Ethnic Factors民族因素,E5(R1)Ethnic Factors in the Acceptability of Foreign Clinical Data E5
32、 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data,E6 Good Clinical Practice 临床试验规范,E6(R1)Good Clinical Practice E6(R2)Addendum: Good Clinical Practice,E7 Clinical Trials in Geriatric Population 在老年人群中的临床试验,E7 Studies in Support of Special Populations: Geria
33、trics E7 Q&AsQuestions & Answers: Studies in Support of Special Populations : Geriatrics,E8 General Considerations for Clinical Trials 临床试验的一般考虑,E8 General Considerations for Clinical Trials,E9 Statistical Principles for Clinical Trials 临床试验的统计学原理,E9 Statistical Principles for Clinical Trials E9(R1)
34、Addendum: Statistical Principles for Clinical Trials,E10 Choice of Control Group in Clinical Trials临床试验中对照组的选择,E10 Choice of Control Group and Related Issues in Clinical Trials在临床试验中的对照组和相关问题的选择,E11 Clinical Trials in Pediatric Population在儿科临床试验,E11 Clinical Investigation of Medicinal Products in th
35、e Pediatric Population E11(R1)Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population,E12 Clinical Evaluation by Therapeutic Category治疗类别临床评价,E12 Principles for Clinical Evaluation of New Antihypertensive Drugs,E14 Clinical Evaluation临床评价,E14The Clinical Evaluation of QT/Q
36、Tc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14 Q&As R2Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs,E15 Definitions in Pharmacogenetics / Pharmacogenomics药理学/药物基因组学的定义,E15 D
37、efinitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories,E16 Qualification of Genomic Biomarkers 基因组生物标志物的资格,E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions药物或生物技术产
38、品开发相关的生物标志物：上下文，结构和资格文件格式,E17 Multi-Regional Clinical Trials多区域临床试验,E17 General principle on planning/designing Multi-Regional Clinical Trials在规划/设计多区域临床试验的一般原则,E18 Genomic Sampling Methodologies 基因组取样方法,E18 Genomic Sampling Methodologies for Future Use,Cross-cutting Topics,Cross-cutting Guidelines,
39、四、Multidisciplinary Guidelines 多学科指南,Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfe
40、r of Regulatory Information (ESTRI).,M1 MedDRA Terminology 常用医学名词 （MedDRA）,MedDRA Medical Dictionary for Regulatory Activities,M2 Electronic Standards 药政信息传递之电子标准,ESTRI Electronic Standards for the Transfer of Regulatory Information药政信息传递之电子标准,M3 Nonclinical Safety Studies 非临床试验安全研究,M3(R2) Guidance
41、on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2) Q&As R2 Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals,M4 Common Techni
42、cal Document 通用技术文件(CTD),CTD The Common Technical Document,M5 Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准,M5 Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准,M6 Gene Therapy 基因治疗,M6 Virus and Gene Therapy Vector Shedding and Transmission病毒和基因治疗载体脱落和传输,M7 Genotoxic Impurities 基因毒性杂质,M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk评估与DNA反应的控制（突变）的杂质在药品限制潜在的致癌风险,M8 Electronic Common Technical Document (eCTD),Electronic Common Technical Document (eCTD)电子通用技术文件（ECTD）,
