ICH-指導(dǎo)原則文件目錄.docx

人用藥品注冊技術(shù)要求國際協(xié)調(diào)會（ICH）文件目錄ICH的論題主要分為四類，因此ICH根據(jù)論題的類別不同而進(jìn)行相應(yīng)的編碼分類：1.“Q”類論題：Q代表QUALITY，指那些與化工和醫(yī)藥，質(zhì)量保證方面的相關(guān)的論題。Q1/Q2.Q10都屬于這類。2.“S”類論題：S代表SAFETY，指那些與實(shí)驗(yàn)室和動物實(shí)驗(yàn)，臨床前研究方面的相關(guān)的論題。3.“E”類論題：E代表EFFICACY，指那些與人類臨床研究相關(guān)的課題。4.“M”類論題：M代表MULTIDISCIPLINARY，指那些不可單獨(dú)劃入以上三個分類的交叉涉及的論題。一、ICH. 質(zhì)量部分（Quality） Q1: Stability穩(wěn)定性 1. Q1A(R2): Stability Testing of New Drug Substances and Products 新原料藥和制劑的穩(wěn)定性試驗(yàn) 2. Q1B: Photostability Testing of New Drug Substances and Products 新原料藥和制劑的光穩(wěn)定性試驗(yàn) 3. Q1C: Stability Testing for New Dosage Forms 新劑型的穩(wěn)定性試驗(yàn) 4. Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products 原料藥和制劑穩(wěn)定性試驗(yàn)的交叉和矩陣設(shè)計5. Q1E: Evaluation of Stability Data穩(wěn)定性數(shù)據(jù)的評估 6. Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV 在氣候帶III和IV，藥物注冊申請所提供的穩(wěn)定性數(shù)據(jù)Q2: Analytical Validation分析驗(yàn)證 7. Q2(R1): Validation of Analytical Procedures: Text and Methodology 分析程序的驗(yàn)證：正文及方法論 Q3A - Q3D: Impurities 雜質(zhì) 8. Q3A(R2): Impurities in New Drug Substances 新原料藥中的雜質(zhì) 9. Q3B(R2): Impurities in New Drug Products (Revised Guideline) 新制劑中的雜質(zhì) 10. Q3C(R5): Impurities: Guideline for Residual Solvents 雜質(zhì)：殘留溶劑指南 11. Q3C(R6): Impurities: Guideline for Residual Solvents PDE for Triethylamine and PDE for Methylisobutylketone 雜質(zhì)：殘留溶劑指南 三乙胺的日允許接觸劑量及甲基異丁基酮的日允許接觸劑量12. Q3D: Guideline for Elemental impurities主要雜質(zhì)指南Q4 - Q4B: Pharmacopoeias藥典 13. Q4A: Pharmacopoeial Harmonisation 藥典的協(xié)調(diào) 14. Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions ICH地區(qū)使用的藥典正文評估和建議 15. Q4B Annex1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter 附錄1 ICH地區(qū)使用的藥典正文評估和建議灼燒殘?jiān)?灰分 通則 16. Q4B Annex2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter 附錄2 ICH地區(qū)使用的藥典正文評估和建議注射劑可提取體積測試 通則 17. Q4B Annex3(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter 附錄3 地區(qū)使用的藥典正文評估和建議 顆粒污染物測試:不溶性微粒 通則18. Q4B ANNEX 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-sterile Products：Microbial Enumerations Tests General Chapter附錄4A(R1) 地區(qū)使用的藥典正文評估和建議 非無菌產(chǎn)品微生物檢驗(yàn):微生物計數(shù)法 通則19. Q4B ANNEX 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-sterile Products：Test for Specified Micro-organisms General Chapter附錄4B(R1) 地區(qū)使用的藥典正文評估和建議 非無菌產(chǎn)品微生物檢驗(yàn):控制菌檢查法 通則20. Q4B ANNEX 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-sterile Products：Acceptance Criteria For Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter附錄4C(R1) 地區(qū)使用的藥典正文評估和建議 非無菌產(chǎn)品微生物檢驗(yàn):藥物制劑及原料藥的認(rèn)可標(biāo)準(zhǔn) 通則21. Q4B ANNEX 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter附錄5(R1) ICH地區(qū)使用的藥典正文評估和建議崩解試驗(yàn) 通則22. Q4B ANNEX 6 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of dosage units General Chapter附錄6 ICH地區(qū)使用的藥典正文評估和建議含量均勻度 通則23. Q4B ANNEX 7(R2) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter附錄7(R2) ICH地區(qū)使用的藥典正文評估和建議溶解度測試 通則24. Q4B ANNEX 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter附錄8(R1) ICH地區(qū)使用的藥典正文評估和建議無菌檢查 通則25. Q4B ANNEX 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter附錄9(R1) ICH地區(qū)使用的藥典正文評估和建議片劑脆碎度檢查 通則26. Q4B ANNEX 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter附錄10(R1) ICH地區(qū)使用的藥典正文評估和建議聚丙烯酰胺凝膠電泳 通則27. Q4B ANNEX 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter附錄11 ICH地區(qū)使用的藥典正文評估和建議毛細(xì)管電泳 通則28. Q4B ANNEX 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter附錄12 ICH地區(qū)使用的藥典正文評估和建議分析篩選 通則29. Q4B ANNEX 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter附錄13 ICH地區(qū)使用的藥典正文評估和建議粉末的松密度與緊密度 30. Q4B ANNEX 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter附錄14 ICH地區(qū)使用的藥典正文評估和建議細(xì)菌內(nèi)毒素檢測 通則Q5A - Q5E: Quality of Biotechnological Products 生物技術(shù)制品質(zhì)量 31. Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 來源于人或者動物細(xì)胞系的生物技術(shù)產(chǎn)品的病毒安全性評估 32. Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products 生物技術(shù)產(chǎn)品的質(zhì)量：rDNA衍生蛋白質(zhì)產(chǎn)品生產(chǎn)細(xì)胞的表達(dá)構(gòu)建體分析33. Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products 生物技術(shù)產(chǎn)品的質(zhì)量：生物技術(shù)產(chǎn)品/生物制品的穩(wěn)定性試驗(yàn) 34. Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products 用于生產(chǎn)生物技術(shù)產(chǎn)品/生物制品的細(xì)胞基質(zhì)的來源和鑒定 35. Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 生產(chǎn)工藝變更后生物技術(shù)產(chǎn)品/生物制品的可比性 Q6A- Q6B: Specifications 質(zhì)量標(biāo)準(zhǔn)36. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including decision trees) 規(guī)范：新原料藥和新制劑的檢測方法和可接收標(biāo)準(zhǔn)：化學(xué)物質(zhì)(包括決定過程) 37. Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 規(guī)范：生物技術(shù)產(chǎn)品/生物制品的檢驗(yàn)方法和可接收標(biāo)準(zhǔn) Q7: Good Manufacturing Practices （GMP）良好的生產(chǎn)質(zhì)量管理規(guī)范38. Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 藥物活性成份的GMP指南 Q8: Pharmaceutical Development 藥物開發(fā)39. Q8(R2): Pharmaceutical Development 藥物開發(fā)Q9: Quality Risk Management 質(zhì)量風(fēng)險管理40. Q9: Quality Risk Management質(zhì)量風(fēng)險管理 Q10: Pharmaceutical Quality System 藥物質(zhì)量體系41. Q10: Pharmaceutical Quality System 藥物質(zhì)量體系Q11：Development and Manufacture of Drug Substances 原料藥的開發(fā)與制造42. Q11:Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)原料藥的開發(fā)與制造（化學(xué)實(shí)體與生物技術(shù)/生物制品實(shí)體）二、ICH.安全性部分(Safety) S1A - S1C: Carcinogenicity Studies致癌試驗(yàn) 1. S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals 藥物致癌試驗(yàn)的必要性 2. S1B: Testing for Carcinogenicity of Pharmaceuticals 藥物致癌試驗(yàn) 3. S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals藥物致癌試驗(yàn)的劑量選擇 S2 Genotoxicity Studies遺傳毒性 4. S2(R1) : Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 人用藥物的遺傳毒性試驗(yàn)和數(shù)據(jù)分析指導(dǎo)原則S3A - S3B: Toxicokinetics and Pharmacokinetics毒物代謝動力學(xué)與藥物代謝動力學(xué)5. S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 毒物代謝動力學(xué)指南的注釋：毒性研究中全身暴露的評價 6. S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 藥物代謝動力學(xué)：重復(fù)給藥的組織分布研究指導(dǎo)原則 S4: Toxicity Testing毒性試驗(yàn) 7. S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 動物體內(nèi)慢性毒性持續(xù)時間的檢驗(yàn)（嚙齒類和非嚙齒類毒性試驗(yàn)） S5: Reproductive Toxicology生殖毒性8. S5(R2) : Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility 藥品的生殖毒性檢測及雄性生育力毒性 S6: Biotechnological Products生物技術(shù)產(chǎn)品 9. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 生物技術(shù)藥品的臨床前安全性試驗(yàn) S7A - S7B: Pharmacology Studies 藥理學(xué)研究10. S7A: Safety Pharmacology Studies for Human Pharmaceuticals 人用藥物的安全性藥理研究 11. S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals人用藥延遲心室復(fù)極化（QT間期延長）潛在作用的非臨床評價指導(dǎo)原則 S8: Immunotoxicology Studies 免疫毒理學(xué)研究12. S8: Immunotoxicity Studies for Human Pharmaceuticals人用藥品的免疫毒理學(xué)研究 S9: Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌藥物臨床前評價13. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌藥物的臨床前評價S10: Photosafety Evaluation 光安全評價14. S10: Photosafety Evaluation of Pharmaceuticals 藥物的光安全評價三、ICH.臨床部分(Efficacy) E1: Clinical Safety for Drugs used in Long-Term Treatment長期治療藥物的臨床安全性1. E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions 對非危及生命的疾病的長期治療藥物進(jìn)行臨床安全性評估的人群暴露程度E2A - E2F: Pharmacovigilance藥物警戒2. E2A: Definitions and Standards for Expedited Reporting 快速報告的定義和標(biāo)準(zhǔn)3. E2C(R2): Periodic Benefit-Risk Evaluation Report 上市藥品定期風(fēng)險效益評估報告4. E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批準(zhǔn)后安全性數(shù)據(jù)管理：快速報告的定義和標(biāo)準(zhǔn) 5. E2E: Pharmacovigilance Planning藥物警戒計劃 6. E2F: Development Safety Update Report 安全性更新報告E3: Clinical Study Reports 臨床研究報告7. E3: Structure and Content of Clinical Study Reports 臨床研究報告的結(jié)構(gòu)與內(nèi)容 E4: Dose-Response Studies 量效研究8. E4: Dose-Response Information to Support Drug Registration 新藥注冊所需量-效關(guān)系的資料 E5: Ethnic Factors 種族因素9. E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data 對國外臨床研究資料的種族因素的可接受性 E6: Good Clinical Practice藥品臨床研究規(guī)范10. E6(R1): Good Clinical Practice: Consolidated Guideline 藥品臨床研究規(guī)范（GCP）一致性指導(dǎo)原則 11. E6(R2): Integrated Addendum to ich E6(R1): Guideline for Good Clinical Practice E6(R1)整合的附錄：藥品臨床研究規(guī)范指南E7: Clinical Trials in Geriatric Population 老年人群的臨床研究12. E7: Studies in Support of Special Populations: Geriatrics 老年人群的臨床研究 E8: General Considerations for Clinical Trials 臨床研究總則13. E8: General Considerations for Clinical Trials 臨床研究總則E9: Statistical Principles for Clinical Trials 臨床研究的統(tǒng)計原則14. E9: Statistical Principles for Clinical Trials 臨床研究統(tǒng)計原則 E10: Choice of Control Group in Clinical Trials 臨床研究對照組的選擇15. E10: Choice of Control Group and Related Issues in Clinical Trials 臨床研究對照組的選擇及相關(guān)問題E11: Clinical Trials in Pediatric Population 兒童人群的臨床研究16. E11: Clinical Investigation of Medicinal Products in the Pediatric Population 兒童人群的臨床研究 E12: Clinical Evaluation by Therapeutic Category 按治療分類的各類藥物臨床評價17. E12: Principles for Clinical Evaluation of New Antihypertensive Drugs 抗高血壓新藥的臨床評價指導(dǎo)原則E14: Clinical Evaluation of QT QT臨床評價18. E14: The Clinical Evaluation of QT/QTc Interval Prolongation and ProarrhythmicPotential for Non-Antiarrhythmic Drugs 非抗心律失常藥物致QT/QTc間期延長及潛在心律失常作用的臨床評價E15: Definitions in Pharmacogenetics / Pharmacogenomics 遺傳藥理學(xué)/藥物基因組學(xué)的定義19. E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories基因組生物標(biāo)記物、藥物基因組學(xué)、遺傳藥理學(xué)、基因組數(shù)據(jù)和樣本編碼分類的定義E16: Qualification of Genomic Biomarkers 基因生物標(biāo)記物的條件20. E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions與藥物或生物技術(shù)產(chǎn)品相關(guān)的生物標(biāo)記物研發(fā): 申請資料的內(nèi)容、結(jié)構(gòu)和格式E17: Multi-Regional Clinical Trials多個地區(qū)臨床試驗(yàn)21. E17: General principle on planning/designing Multi-Regional Clinical Trials 規(guī)劃多地區(qū)臨床試驗(yàn)的一般原則E18: Genomic Sampling 基因組抽樣22. E18: Guideline on Genomic Sampling and Management of Genomic Data基因組數(shù)據(jù)采集與管理的指導(dǎo)原則四、ICH.綜合部分 (Multidisciplinary)M1: MedDRA Terminology 醫(yī)學(xué)術(shù)語M2: Electronic Standards 電子標(biāo)準(zhǔn)M3: Nonclinical Safety Studies臨床前安全性研究1. M3: Guidance on Nonclinical Safety Stud