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[指导原则] 2017.6.20审核查验中心全套ICH指导原则的中文版

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         2017.6.20审核查验中心全套ICH指导原则的中文版



  • ines
    有效性


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    Multidisciplinary Guidelines
    多学科综合



ICH动态
http://www.cfdi.org.cn/cfdi/index?module=A009&m1=10&m2=&nty=F02&tcode=F01



Quality Guidelines(质量)
编号
阶段
发布日期
内容
Q1 Stability (稳定性)
Q1A(R2)
Step 5
2003-2-6
Stability Testing of New Drug Substances and Products
新原料药和制剂的稳定性试验
Q1B
Step 5
1996-11-6
Stability Testing : Photostability Testing of New Drug Substances and Products
稳定性试验:新原料药和制剂的光稳定性试验
Q1C
Step 5
1996-11-6
Stability Testing for New Dosage Forms
[url=]稳定性试验:新剂型的要求
Q1D
Step 5
2002-2-7
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
新原料药和制剂稳定性试验的括号法和矩阵法设计
Q1E
Step 5
2003-2-6
Evaluation of Stability Data[/url]
稳定性数据的评价[/url]
Q1F
废止
废止时间:2006-6-8
Stability Data Package for Registration Applicati** in Climatic Zones III and IV
气候带III和IV注册申请的稳定性数据包
Q2 Analytical Validation (分析方法验证)
Q2(R1)
Step 5
2005-11
Validation of Analytical Procedures: Text and Methodology
分析方法验证:文本及方法学
Q3 Impurities (杂质)
Q3A(R2)
Step 5
2006-10-25
Impurities in New Drug Substances
新原料药中的杂质
Q3B(R2)
Step 5
2006-6-2
Impurities in New Drug Products
新药制剂中的杂质
Q3C(R6)
Step 5
2016-10-20
Impurities: Guideline for Residual Solvents
杂质:残留溶剂指南
Q3D
Step 5
2014-12-16
Guideline for Elemental Impurities
元素杂质指南
Q4 Pharmacopoeias (药典)
Q4

Pharmacopoeias
药典
Q4A

Pharmacopoeial Harmonisation
药典的同一化
Q4B
Step 5
2007-11-1
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regi**
ICH各地区使用的药典正文评估和建议
Q4B Annex 1 (R1)
Step 5
2010-9-27
Residue on Ignition/Sulphated Ash General Chapter
关于ICH区域内药典附录的评价及建议-炽灼残渣(硫酸灰分)检查法
Q4B Annex 2 (R1)
Step 5
2010-9-27
Test for Extractable Volume of Parenteral Preparati** General Chapter
关于ICH区域内药典附录的评价及建议-注射剂装量检查法
Q4B Annex 3 (R1)
Step 5
2010-9-27
Test for Particulate Con**ination: Sub-Visible Particles General Chapter
关于ICH区域内药典附录的评价及建议-不溶性微粒检查法
Q4B Annex 4A (R1)
Step 5
2010-9-27
[url=]Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查:微生物计数法
Q4B Annex 4B (R1)
Step 5
2010-9-27
Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查:控制菌检查法
Q4B Annex 4C (R1)
Step 5
2010-9-27
Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparati** and Substances for Pharmaceutical Use General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查:原料药及其制剂的判定标准
Q4B Annex 5 (R1)
Step 5
2010-9-
Disintegration Test General Chapter
[url=]关于ICH区域内药典附录的评价及建议-崩解时限检查法[/url]
Q4B Annex 6
Step 5
2013-11-13
[url=]Uniformity of Dosage Units General Chapter[/url]
关于ICH区域内药典附录的评价及建议-含量均匀度检查法
Q4B Annex 7 (R2)
Step 5
2010-11-11
[url=]Dissolution Test General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-溶出度检查法[/url]
Q4B Annex 8 (R1)
Step 5
2010-9-27
[url=]Sterility Test General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-无菌检查法[/url]
Q4B Annex 9 (R1)
Step 5
2010-9-27
[url=]Tablet Friability General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-片剂脆碎度检查法[/url]
Q4B Annex 10 (R1)
Step 5
2010-9-27
[url=]Polyacrylamide Gel Electrophoresis General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-聚丙烯酰胺凝胶电泳法[/url]
Q4B Annex 11
Step 5
2010-6-9
[url=]Capillary Electrophoresis General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-毛细管电泳法[/url]
Q4B Annex 12
Step 5
2010-6-9
[url=]Analytical Sieving General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-筛分法[/url]
Q4B Annex 13
Step 5
2012-6-7
[url=]Bulk Density and Tapped Density of Powders General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-粉末的堆密度和拍实密度测定法[/url]
Q4B Annex 14
Step 5
2012-10-18
[url=]Bacterial Endotoxins Test General Chapter[/url]
[url=]关于ICH区域内药典附录的评价及建议-细菌内毒素检查法[/url]
Q5 Quality of Biotechnological Products (生物技术产品的质量)
Q5A(R1)
Step 5
1999-9-23
[url=]Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin[/url]
[url=]来源于人或动物细胞系的生物技术产品的病毒安全性评价[/url]
Q5B
Step 5
1995-11-30
[url=]Quality of Biotechnological Products: Analysis of the Expression C**truct in Cells Used for Production of r-DNA Derived Protein Products[/url]
[url=]生物技术产品的质量:rDNA衍生蛋白质产品生产细胞的表达构建体分析[/url]
Q5C
Step 5
1995-11-30
[url=]Quality of Biotechnological Products: Analysis of the Expression C**truct in Cells Used for Production of r-DNA Derived Protein Products[/url]
[url=]生物技术产品的质量:生物制品/生物技术产品的稳定性试验[/url]
Q5D
Step 5
1997-7-16
[url=]Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products[/url]
[url=]用于生物技术产品及生物制品生产的细胞基质的来源和鉴定[/url]
Q5E
Step 5
2004-11-18
[url=]Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process[/url]
[url=]生物技术产品/生物制品在工艺变更时的可比性[/url]
Q6 Specificati** (质量标准)
Q6A
Step 5
1999-10-6
[url=]Specificati** : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances[/url]
[url=]质量标准 新原料药和制剂的检测以及可接受标准:化学物质[/url]
Q6B
Step 5
1999-3-10
[url=]Specificati** : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products[/url]
[url=]质量标准:生物技术产品以及生物制品的检测方法和可接受标准[/url]
Q7 Good Manufacturing Practice (生产质量管理规范)
Q7
Step 5
2000-11-10
[url=]Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients[/url]
原料药生产的GMP指南
Q7 Q&As
Step 5
2015-6-10
[url=]Questi** and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients[/url]
[url=]原料药生产的GMP指南的问与答[/url]
Q8 Pharmaceutical Development (药品研发)
Q8(R2)
Step 5
2009-8
[url=]Pharmaceutical Development[/url]
[url=]药品研发[/url]
Q9 Quality Risk Management (质量风险管理)
Q9
Step 5
2005-11-9
[url=]Quality Risk Management[/url]
质量风险管理
Q10 Pharmaceutical Quality System (药物质量体系)
Q10
Step 5
2008-6-4
[url=]Pharmaceutical Quality System[/url]
[url=]药品质量体系[/url]
Q8/9/10 Q&As(R4)
Step 5

[url=]Q8/Q9/Q10 Questi** and Answers[/url]
[url=]Q8,Q9,Q10的问与答[/url]
Q11 Development and Manufacture of Drug Substances (原料药而研发和生产)
Q11
Step 5
2012-5-1
[url=]Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)[/url]
[url=]药物的研发和生产(化学实体和生物技术产品/生物制品实体)[/url]
Q11 Q&As
Step 3

[url=]Questi** & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances[/url]
Q11的问与答
Q12 Lifecycle Management (生命周期管理)
Q12
Step 1

Technical and Regulatory C**iderati** for Pharmaceutical Product Lifecycle Management
药品生命周期的技术和监管考虑



Safety Guidelines(安全性)
编号
阶段
发布日期
内容
S1 Carcinogenicity Studies (致癌性研究)
S1A
Step 5
1995-11-29
[url=]Need for Carcinogenicity Studies of Pharmaceuticals[/url]
[url=]药物致癌试验的必要性[/url]
S1B
Step 5
1997-07-16
[url=]Testing for Carcinogenicity of Pharmaceuticals[/url]
[url=]药物致癌试验[/url]
S1C(R2)
Step 5
2008-03-11
[url=]Dose Selection for Carcinogenicity Studies of Pharmaceuticals[/url]
[url=]药物致癌试验的剂量选择[/url]
S2 Genotoxicity Studies (遗传毒性研究)
S2(R1)
Step 5
2011-11-09
[url=]Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use[/url]
[url=]人用药物的遗传毒性试验和数据分析指导原则[/url]
S3 Toxicokinetics and Pharmacokinetics (毒代动力学和药代动力学)
S3A
Step 5
1994-10-27
[url=]Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies[/url]
[url=]毒代动力学指导原则:毒性研究中全身暴露的评价[/url]
S3A Q&As
Step 3

[url=]Questi** and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling[/url]
S3A问与答
S3B
Step 5
1994-10-27
[url=]Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies[/url]
[url=]药代动力学:重复给药的组织分布研究指导原则[/url]
S4 Toxicity Testing (毒性试验)
S4
Step 5
1998-09-02
[url=]Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)[/url]
[url=]动物慢性毒性试验的周期(啮齿类和非啮齿类)[/url]
S5 Reproductive Toxicology (生殖毒性)
S5(R2)
Step 5
2005-11
[url=]Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility[/url]
[url=]药物生殖毒性和雄性生育力毒性的检测[/url]
S6 Biotechnological Products (生物技术药品)
S6(R1)
Step 5
2011-6
[url=]Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals[/url]
[url=]生物技术药品的临床前安全性试验[/url]
S7 Pharmacology Studies (药理学研究)
S7A
Step 5
2000-11-8
[url=]Safety Pharmacology Studies for Human Pharmaceuticals[/url]
[url=]人用药物的安全性药理学研究[/url]
S7B
Step 5
2005-5-12
[url=]The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals[/url]
[url=]人用药延迟心室复极化(QT间期延长)潜在作用的非临床评价指导原则[/url]
S8 Immunotoxicology Studies (免疫毒性研究)
S8
Step 5
2005-9-15
[url=]Immunotoxicity Studies for Human Pharmaceuticals[/url]
[url=]人用药品的免疫毒性研究[/url]
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (抗癌药物的非临床研究)
S9
Step 5
2009-10-29
[url=]Nonclinical Evaluation for Anticancer Pharmaceuticals[/url]
[url=]抗癌药物的非临床评价[/url]
S9 Q&As
Step 3

[url=]Questi** and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals[/url]
抗癌药物非临床评价的问与答
S10 Photosafety Evaluation (光安全性研究)
S10
Step 5
2013-11-13
[url=]Photosafety Evaluation of Pharmaceuticals[/url]
药物的光安全性评价
S11 Nonclinical Safety Testing (非临床安全性试验)
S11
Step 1

Nonclinical Safety Testing in Support of Development of Paediatric Medicines
支持儿科药物研发的非临床研究


Efficacy Guidelines(有效性)
编号
阶段
发布日期
内容
E1 Clinical Safety for Drugs used in Long-Term Treatment (长期用药的临床安全性)
E1
Step 5
1994-10-27
[url=]The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditi**[/url]
[url=]对非危及生命的疾病的长期治疗药物进行临床安全性评估的人群暴露程度[/url]
E2 Pharmacovigilance (药物警戒)
E2A
Step 5
1994-10-27
[url=]Clinical Safety Data Management: Definiti** and Standards for Expedited Reporting[/url]
[url=]临床安全性数据管理:快速报告的定义和标准[/url]
E2B(R3)
Step 5
2015-4
[url=]Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports[/url]
临床安全性数据管理:个体病例安全性报告传递的数据要素
E2B(R3) IWG
Step 5
2016-6-16
[url=]Implementation: Electronic Transmission of Individual Case Safety Reports[/url]
关于E2B(R3)实施的问与答
E2C(R2)
Step 5
2012-12-17
[url=]Periodic Benefit-Risk Evaluation Report[/url]
上市药品定期风险效益评估报告
E2C(R2) Q&As
Step 5
2014-3-31
[url=]Questi** & Answers: Periodic Benefit-Risk Evaluation Report[/url]
上市药品定期风险效益评估报告的问与答
E2D
Step 5
2003-11-12
[url=]Post-Approval Safety Data Management: Definiti** and Standards for Expedited Reporting[/url]
[url=]批准后的安全数据管理:快速报告的定义和标准[/url]
E2E
Step 5
2004-11-18
[url=]Pharmacovigilance Planning[/url]
[url=]药物警戒计划[/url]
E2F
Step 5
2010-8-17
[url=]Development Safety Update Report[/url]
[url=]研发安全性更新报告[/url]
E3 Clinical Study Reports (临床研究报告)
E3
Step 5
1995-11-30
[url=]Structure and Content of Clinical Study Reports[/url]
临床研究报告的结构与内容
E3 Q&As (R1)
Step 5
2012-7-6
[url=]Questi** & Answers: Structure and Content of Clinical Study Reports[/url]
[url=]临床研究报告的结构与内容问与答[/url]
E4 Dose-Resp**e Studies (量-效关系研究)
E4
Step 5
1994-3-10
[url=]Dose-Resp**e Information to Support Drug Registration[/url]
[url=]新药注册所需的量-效关系资料[/url]
E5 Ethnic Factors (种族因素)
E5(R1)
Step 5
1998-2-5
[url=]Ethnic Factors in the Acceptability of Foreign Clinical Data[/url]
[url=]引入海外临床数据时要考虑的种族因素[/url]
E5 Q&As (R1)
Step 5
2006-6-2
[url=]Questi** & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data[/url]
[url=]引入海外临床数据时要考虑的种族因素的问与答[/url]
E6 Good Clinical Practice (药物临床研究质量管理规范)
E6(R1)
Step 5
1996-6-10
[url=]Good Clinical Practice[/url]
[url=]药品临床研究规范(GCP)一致性指导原则[/url]
E6(R2)
Step 5
2016-11-9
[url=]Integrated Addendum to Good Clinical Practice (GCP)[/url]
2016版ICH GCP
E7 Clinical Trials in Geriatric Population (老年人群的临床试验)
E7
Step 5
1993-6-24
[url=]Studies in Support of Special Populati**: Geriatrics[/url]
[url=]老年人群的临床研究[/url]
E7 Q&As
Step 5
2010-7-6
[url=]Questi** & Answers: Studies in Support of Special Populati** : Geriatrics[/url]
[url=]老年人群的临床研究的问与答[/url]
E8 General C**iderati** for Clinical Trials (临床试验的一般考虑)
E8
Step 5
1997-7-17
[url=]General C**iderati** for Clinical Trials[/url]
[url=]临床试验的一般考虑[/url]
E9 Statistical Principles for Clinical Trials (临床试验的统计原则)
E9
Step 5
1998-2-5
[url=]Statistical Principles for Clinical Trials[/url]
[url=]临床试验统计原则[/url]
E9(R1)
Step 1

Addendum: Statistical Principles for Clinical Trials
E9附录
E10 Choice of Control Group in Clinical Trials (临床试验中对照组的选取)
E10
Step 5
2000-7-20
[url=]Choice of Control Group and Related Issues in Clinical Trials[/url]
[url=]临床试验的对照组选择及相关问题[/url]
E11 Clinical Trials in Pediatric Population (儿童用药品的临床试验)
E11
Step 5
2000-7-20
[url=]Clinical Investigation of Medicinal Products in the Pediatric Population[/url]
[url=]儿童用药品的临床调查[/url]
E11(R1)
Step 3

Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
E11附录
E12 Clinical Evaluation by Therapeutic Category (新抗高血压药的临床评价)
E12
Step 5
2000-3-2
[url=]Principles for Clinical Evaluation of New Antihypertensive Drugs[/url]
[url=]新抗高血压药的临床评价原则[/url]
E14 Clinical Evaluation of QT (QT临床评价)
E14
Step 5
2005-5-12
[url=]The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs[/url]
[url=]非抗心律失常药物致QT/QTc间期延长及潜在心律失常作用的临床评价[/url]
E14 Q&As (R3)
Step 5
2015-12-10
[url=]Questi** & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs[/url]
E14的问与答
E14/S7B
Step 1

Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation
QT/QTc间期延长的临床和非临床评价讨论组
E15 Definiti** in Pharmacogenetics / Pharmacogenomics (药物遗传学/药物基因组学的定义)
E15
Step 5
2007-11-1
[url=]Definiti** for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories[/url]
[url=]基因组生物标记物、药物基因组学、遗传药理学、基因组数据和样本编码分类的定义[/url]
E16 Qualification of Genomic Biomarkers (基因组生物标记物的条件)
E16
Step 5
2010-8-20
[url=]Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissi**[/url]
[url=]与药物或生物技术产品相关的生物标记物研发:申请资料的内容、结构和格式[/url]
E17 Multi-Regional Clinical Trials (国际多中心临床试验)
E17
Step 3

General principle on planning/designing Multi-Regional Clinical Trials
国际多中心临床试验计划与设计原则
E18 Genomic Sampling (基因组采样)
E18
Step 3

Genomic Sampling and Management of Genomic Data
基因组样品采集和基因组数据管理指南


Multidisciplinary Guidelines(多学科综合)
编号
阶段
发布日期
内容
M1 MedDRA Terminology (监管活动医学术语)
M1
Version 20.0
2017-3-1
Medical Dictionary for Regulatory Activities(MedDRA )
监管活动医学术语
M2 Electronic Standards (电子标准)
M2

Electronic Standards for the Transfer of Regulatory Information(ESTRI)
监管信息传输电子标准
M3 Nonclinical Safety Studies (非临床安全性研究)
M3(R2)
Step 5
2009-6-11
[url=]Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals[/url]
[url=]药物进行人体临床试验和上市许可申请的非临床安全性研究指导原则[/url]
M3(R2) Q&As (R2)
Step 5
2012-3-5
[url=]Questi** & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals[/url]
[url=]M3的问与答[/url]
M4 Common Technical Document (通用技术文件)
M4

The Common Technical Document(CTD)
通用技术文件
M4(R4)
Step 5
2016-6-15
[url=]Organisation of the Common Technical Document For The Registration of Pharmaceuticals for human use[/url]
人用药物注册申请的通用技术文件组织结构
M4Q(R1)
Step 5
2002-9-12
[url=]The Common Technical Document for the Registation of Pharmaceuticals for Human Use: Quality[/url]
人用药物注册申请的通用技术文件:质量
M4S(R2)
Step 5
2002-12-20
[url=]The Common Technical Document for the Registration of Pharmaceuticals for human Use: Safety[/url]
人用药物注册申请的通用技术文件:安全性
M4E(R1)
Step 5
2002-9-12
[url=]The Common Technical Document for the Registration of Pharmaceuticals for Human Use:Efficacy[/url]
[url=]人用药物注册申请的通用技术文件:有效性[/url]
M4E(R2)
Step 5
2016-6-15
[url=]Revision of M4e Guideline on Enhancing the Format and Structure of Benefit-risk Information in Ich[/url]
M4E指南修订,优化临床研究风险评估的格式与结构
M5 Data Elements and Standards for Drug Dictionaries (药物词汇的数据要素和标准)
M5

Data Elements and Standards for Drug Dictionaries
药物词汇的数据要素和标准
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的脱落和传播
M7 Genotoxic Impurities (基因毒性杂质)
M7
Step 5
2014-6-23
[url=]Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk[/url]
为限制潜在致癌风险而对药物中DNA活性(诱变性)杂质进行的评估和控制
M7 Addendum
Step 3

[url=]M7 Addendum[/url]
M7附录
M8 Electronic Common Technical Document (eCTD) (电子通用技术文件)
M8
Step 4

Electronic Common Technical Document (eCTD)
电子通用技术文件
M9 Biopharmaceutics Classification System-based Biowaivers (基于生物药剂学分类系统的生物豁免)
M9
Step 1

Biopharmaceutics Classification System-based Biowaivers
基于生物药剂学分类系统的生物豁免
M10 Bioanalytical Method Validation (生物样品分析的方法验证)
M10
Step 1

Bioanalytical Method Validation
生物样品分析的方法验证



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