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1、ICH Guidelines,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） M2: 药政信息传递之电子标
2、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 to pharmaceutic
3、al 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 Testing for New Do
4、sage 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,Q2 Analytic
5、al 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 for Eleme
6、ntal 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 Ignition/
7、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 Examinatio
8、n 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: Acceptance Crit
9、eria 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 - Q4B Pha
10、rmacopoeias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 General Chapt
11、er 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 Analysis of
12、 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 of Biot
13、echnological/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 Substa
14、nces 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 Act
15、ive 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 Qua
16、lity 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 (Chemical Entities and Biotechnological/Biological Entities) Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substa
