最新ICH指导原则最新版本

1、精选pptICH Guidelines精选pptICH Guidelines精选ppt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） M2: 药政

2、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精选ppt一、一、Quality Guidelines 质量研究指导原则质量研究指导原则 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 ap

3、proach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. 精选pptQ1A - Q1F Stability稳定性稳定性 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

4、Stability Testing 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

5、注册申请所提供的稳定性数据精选pptQ2 Analytical Validation分析验证分析验证Q2(R1)Validation of Analytical Procedures: Text and Methodology分析程序的验证：正文及方法论精选pptQ3A - Q3D Impurities杂质杂质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 Solven

6、ts杂质：残留溶剂指南Q3D Guideline for Elemental Impurities - NEW Q3D Implementation of Guideline for Elemental Impurities 精选pptQ4 - Q4B Pharmacopoeias药典药典 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

7、药典内容的评估及推荐为用于ICH地区地区Q4B Annex 1R1 Residue on 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关于注射剂可提取容量测试 常规篇常规篇Q4B Annex 3R1 Test for Particulate Contamination: Sub-Visible Particles General Chapt

8、er附录附录3 关于颗粒污染物测试关于颗粒污染物测试:不溶性微粒不溶性微粒 常规篇常规篇Q4B Annex 4AR1 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter 精选pptQ4 - Q4B Pharmacopoeias药典药典 Q4B Annex 4BR1 Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General

9、 Chapter Q4B Annex 4CR1 Microbiological Examination of Non-Sterile Products: Acceptance 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 7R

10、2 Dissolution Test General ChapterQ4B Annex 8R1 Sterility Test General Chapter 精选pptQ4 - Q4B Pharmacopoeias药典药典 Q4B Annex 9R1 Tablet Friability General ChapterQ4B Annex 10R1 Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 11 Capillary Electrophoresis General Chapter Q4B Annex 12 Analyti

11、cal Sieving General ChapterQ4B Annex 13 Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 14 Bacterial Endotoxins Test General Chapter Q4B FAQs Frequently Asked Questions 精选pptQ5A - Q5E Quality of Biotechnological Products 生物技术产品的质量生物技术产品的质量Q5A(R1) Viral Safety Evaluation of Biote

12、chnology 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 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的蛋白质产品的生产中所用的细胞中的表达构建分析胞中的表达构建分析Q

13、5C Stability Testing of Biotechnological/Biological Products 生物技术产品的质量：生物技术生物技术产品的质量：生物技术/生物产品的稳定性试验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生物产品的细胞底物的起源和特征描述Q5E Comparability of Bio

14、technological/Biological Products Subject to Changes in their Manufacturing Process 基于不同生产工艺的生物技术产品基于不同生产工艺的生物技术产品/生物产品的可比较性生物产品的可比较性精选pptQ6A- Q6B Specifications规格规格Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格：新原料

15、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：生物技术质量规格：生物技术/生物产品的检验程序和可接生物产品的检验程序和可接收标准收标准精选pptQ7 Good Manufacturing Practice(原料药原料药GMP规范规范) Q7 Good Manufacturing Practice Gu

16、ide for 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 精选pptQ8 Pharmaceutical Development药物开发药物开发Q8(R2) Pharmaceutical Development 药物开发药物开发Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation 精选pptQ9 Qu

17、ality Risk Management质量风险管理质量风险管理 Q9 Quality Risk Management Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation 精选pptQ10 Pharmaceutical Quality System 药物质量体系药物质量体系Q10 Pharmaceutical Quality System 药物质量体系 Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation实施 精选pptQ11 Development and Manufacture of Drug Substances

18、原料药研发与生产 Q11Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances 精选pptQ12 Lifecycle Management生命周期管理 Q12 Technical and

19、 Regulatory Considerations for Pharmaceutical Product Lifecycle Management 精选pptCross-cutting TopicsCross-cutting Guidelines 精选ppt二、二、Safety Guidelines 安全性评价指导原则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 repro

20、toxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. 精选pptS1A - S1C Carcinogenicity Studies致癌性研究 S1 Rodent Carcinogenicity Studies for Human Pharmaceuticals

21、S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals 精选pptS2 Genotoxicity Studies遗传毒性研究 S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Inte

22、nded for Human UseS2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals; S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals; 精选pptS3A - S3B Toxicokinetics and Pharmacokinetics毒代动力学和药代动力学 S3A Note for Guidance on Toxicokinetics: The Ass

23、essment of Systemic Exposure in Toxicity Studies S3A Q&AsQuestions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on MicrosamplingS3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 精选pptS4 Toxicity Testing毒性试验 S4 Duration o

24、f Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 精选pptS5 Reproductive Toxicology生殖毒理学 S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility 精选pptS6 Biotechnological Products生物技术制品 S6(R1) Preclinical Safety Evaluation of Bio

25、technology-Derived Pharmaceuticals 精选pptS7A - S7B Pharmacology Studies药理学研究 S7A Safety Pharmacology Studies for Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals 精选pptS8 Immunotoxicology S

26、tudies免疫毒理学研究S8 Immunotoxicity Studies for Human Pharmaceuticals人类的药物免疫毒性研究 精选pptS9 Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物非临床评价 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals S9 Q&AsQuestions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals 精选pptS10

27、 Photosafety Evaluation光安全评价 S10 Photosafety Evaluation of Pharmaceuticals药物的光安全评价 精选pptS11 Nonclinical Safety Testing非临床安全性试验S11Nonclinical Safety Testing in Support of Development of Paediatric Medicines 精选pptCross-cutting TopicsCross-cutting Guidelines Some ICH Products do not fit uniquely into o

28、ne of the Quality, Safety or Efficacy categories. Those Products can be found under the Mulidisciplinary Section. 精选ppt三、三、Efficacy Guidelines 有效性评价指导原则有效性评价指导原则 The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It

29、also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines 精选pptE1 Clinical 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 Sa

30、fety 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 精选pptE2A - E2F Pharmacovigilance药物警戒E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Tra

31、nsmission of Individual Case Safety Reports E2B(R3) IWGImplementation: Electronic Transmission of Individual Case Safety Reports E2C(R2) Periodic Benefit-Risk Evaluation Report 精选pptE2C(R2) -E2FE2C(R2) Q&AsQuestions & Answers: Periodic Benefit-Risk Evaluation ReportE2D Post-Approval Safety D

32、ata Management: Definitions and Standards for Expedited ReportingE2E Pharmacovigilance PlanningE2F Development Safety Update Report 精选pptE3 Clinical Study Reports临床研究报告 E3 Structure and Content of Clinical Study Reports E3 Q&As R1Questions & Answers: Structure and Content of Clinical Study R

33、eports 精选pptE4 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精选pptE5 Ethnic Factors民族因素 E5(R1)Ethnic Factors in the Acceptability of Foreign Clinical Data E5 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clin

34、ical Data 精选pptE6 Good Clinical Practice临床试验规范 E6(R1)Good Clinical PracticeE6(R2)Addendum: Good Clinical Practice 精选pptE7 Clinical Trials in Geriatric Population在老年人群中的临床试验 E7 Studies in Support of Special Populations: Geriatrics E7 Q&AsQuestions & Answers: Studies in Support of Special Popu

35、lations : Geriatrics 精选pptE8 General Considerations for Clinical Trials临床试验的一般考虑 E8 General Considerations for Clinical Trials精选pptE9 Statistical Principles for Clinical Trials临床试验的统计学原理 E9 Statistical Principles for Clinical TrialsE9(R1)Addendum: Statistical Principles for Clinical Trials 精选pptE10

36、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 精选pptE11 Clinical Trials in Pediatric Population在儿科临床试验 E11 Clinical Investigation of Medicinal Products in the Pediatric Population E11(R1)Addendum: Clinical Inv

37、estigation of Medicinal Products in the Pediatric Population 精选pptE12 Clinical Evaluation by Therapeutic Category治疗类别临床评价 E12 Principles for Clinical Evaluation of New Antihypertensive Drugs 精选pptE14 Clinical Evaluation临床评价 E14The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic

38、 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 精选pptE15 Definitions in Pharmacogenetics / Pharmacogenomics药理学/药物基因组学的定义 E15 Definitions for Genomic Biomar

39、kers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories 精选pptE16 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药物或生物技术产品开发相关的生物标志物：上下文，结构和资格文件格式

40、 精选pptE17 Multi-Regional Clinical Trials多多区域临床试验区域临床试验 E17 General principle on planning/designing Multi-Regional Clinical Trials在规划在规划/设计设计多区域临床试验的一般原则多区域临床试验的一般原则 精选pptE18 Genomic Sampling Methodologies 基因组取样方法基因组取样方法 E18 Genomic Sampling Methodologies for Future Use 精选pptCross-cutting TopicsCross-cutting Guidelines 精选ppt四、四、Multidisciplinary Guidelines多学科指南多学科指南 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 developm