ICH-指导原则文件目录

1、人用药品注册技术要求国际协调会(ich)文件目录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：1“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。q1/q2.q10都属于这类。2“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啖论题：e代表efficacy,指那些与人类临床研究相关的课题。4“nt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。一、ich质量部分(quality)ql:stability 稳定性1. qi

2、 a(r2):stabilitytestingofnewdrugsubstancesandproducts新原料药和制剂的稳定性试验2. q1 b:photostabilitytestingofnewdrugsubstancesandproducts新原料药和制剂的光稳定性试验3. qlc:stabilitytestingfornewdosageforms新剂型的稳定性试验4. qld:bracketingandmatrixingdesignsforstabilitytestingofdrugsubstancesanddr ugproducts原料药和制剂稳定性试验的交叉和矩阵设计5. q1e

3、: evaluation of stability data稳定性数据的评估6. qlf:stabilitydatapackageforregistrationapplicationsinclimaticzonesiiiandiv 在气候带iii和iv,药物注册中请所提供的稳定性数据q2:analyticalvalidation 分析验证7. q2(r 1 ):validationofanalyticalprocedures:textandmethodology分析程序的验证：止文及方法论q3a q3d:impurities 杂质8. q3a(r2):impuritiesinnewdrugsu

4、bstances新原料药中的朵质9. q3b(r2):impuritiesinnewdrugproducts(revisedguideline)新制剂中的杂质10. q3c(r5):impurities:guidelineforresidualsolvents杂质：残留溶剂指南11. q3c(r6): impurities: guideline for residual solventspde for triethylamineand pde for methylisobutylketone杂质：残留溶剂指南三乙胺的曰允许接触剂量及甲基界丁基酮的曰允许接触剂量12. q3d: guidelin

5、e for elemental impurities主要杂质指南q4 q4b:pharmacopoeias 药典13. q4a:pharmacopoeialharmonisation 药典的协调14 q4b:evaluationandrccommendahonofphannacopoeialtextsfofuseintheichregi onsich地区使用的药典正文评估和建议15. q4bannex 1 (r1 )evaluationandrecommendationofpharmacopoeialtextsforusein thelchregionsonresidueonlgnition/

6、sulphatedashgeneralchapter附录1ich地区使用的药典正文评估和建议灼烧残渣/灰分通则16 q4bannex2(r l)evaluationandrecommendationofpharmacopoeialtextsforusein thelchregionsontestforextractablevolumeofparenteralpreparationsgeneralchap ter附录2ich地区使用的药典止文评估和建议 注射剂可提取体积测试通则17. q4bannex3(rl)evaluationandrecommendationofpharmacopoeial

7、textsforusein thelchregions on test for particulate contamination: sub-visible particles general chapter附录3地区使用的药典止文评佔和建议颗粒污染物测试:不溶性微粒通则18. q4b annex 4a(r1) evaluation and recommendation of pharmacopoeial texts for use in the ich regions on microbiological examination of non-sterile products: microb

8、ial enumerations tests general chapter附录4a(r1)地区使用的药典正文评估和建议 非无菌产品微生物检验:微生物计数法通则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附录4b(r1)地区使用

9、的药典正文评估和建议非无菌产品微生物检验:控制菌检查法通则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附录4c(r 1

10、)地区使用的药典正文评估和建议菲无菌产品微生物检验:药物制剂及原料药的认可标准通则21. q4b annex 5(r1) evaluation and recommendation of pharmacopoeial texts for use in the ich regions on disintegration test general chapter附录5(r1) ich地区使用的药典正文评估和建议崩解试验通则22. q4b annex 6 evaluation and recommendation of pharmacopoeial texts for use in the ich

11、regions on uniformity of dosage units general chapter附录6 ich地区使用的药典正文评估和建议 含量均匀度通则23. q4b annex 7(r2) evaluation and recommendation of pharmacopoeial texts for use in the ich regions on dissolutiontest general chapter附录7(r2) ich地区使用的药典正文评估和建议溶解度测试通则24. q4b annex 8(r1) evaluation and recommendation o

12、f pharmacopoeial texts for use in the ich regions on sterility test general chapter附录8(r1) ich地区使用的药典正文评估和建议无菌检查通则25. q4b annex 9(r1) evaluation and recommendation of pharmacopoeial texts for use in the ich regions on tablet friability general chapter附录9(r1) ich地区使用的约典正文评估和建议片剂脆碎度检查通则26. q4b annex 1

13、o(r1) evaluation and recommendation of pharmacopoeial texts for use in the ich regions on polyacrylamide gel electrophoresis general chapter附录1o(r1) ich地区使用的药典正文评估和建议聚丙烯酰胺凝胶电泳通则27. q4b annex 11 evaluation and recommendation of pharmacopoeial texts for use in the ich regions on capillary electrophore

14、sis general chapter附录11 ich地区使用的药典正文评估和建议毛细管电泳通则28. q4b annex 12 evaluation and recommendation of pharmacopoeial texts for use in the ich regions on analytical sieving general chapter附录12 ich地区使用的药典正文评估和建议分析筛选通则29. q4b annex 13 evaluation and recommendation of pharmacopoeial texts for use in the ich

15、 regions on bulk density and tapped density of powders general chapter附录13 ich地区使用的药典正文评估和建议 粉末的松密度与紧密度30. q4b annex 14 evaluation and recommendation of pharmacopoeial texts for use in the ich regions on bacterial endotoxins test general chapter 附录14 ich地区使用的药典正文评估和建议 细菌内毒素检测通则q5a q5e:qualityofbiote

16、chnologicalpn)ducts 生物技术制品质量31. q5a(rl):viralsafetyevaluationofbiotechnologyproductsderivedfromcelllineso fhumanoranimalorigin来源于人或者动物细胞系的牛物技术产品的病毒安全性评估32. q5b:qualityofbiotechnologicalproducts:analysisofthcexpressionconstnjctincel isusedforproductionofr-dnaderivedproteinproducts生物技术产品的质量：rdna衍生蛋口质产

17、品生产细胞的表达构建体分析33. q5c:qualityofbiotechnologicalproducts:stabilitytestingofbiotechnological/biol ogicalproducts牛物技术产詁的质量：牛物技术产詁/牛物制晶的稳定性试验34 q5d:derivationandcharacterizationofcellsubstratesusedforproductionofbiotech nological/biologicalproducts用于生产生物技术产品/生物制品的细胞基质的来源和鉴定35. q5e:comparabilityofbiotechn

18、ological/biologicalproductssubjecttochangesinth eirmanufacturingprocess生产工艺变更后生物技术产品/生物制品的可比性q6a- q6b:specifications质量标准36. q6a:specifications:testproceduresandacceptancecriteriafornewdrugsubstance sandnewdrugproducts:chemicalsubstances(includingdecisiontrees)规范：新原料约和新制剂的检测方法和可接收标准：化学物质(包括决定过程)37. q

19、6b:specifications:testproceduresandacceptancecriteriaforbiotechnological/bi ologicalproducts规范：生物技术产品/生物制品的检验方法和可接收标准q7:goodmanufacturingpractices (gmp)良好的生产质量管理规范38. q7a:goodmanufacturingpracticeguideforactivepharmaceuticalingredients 药物活性成份的gmp指南q8: pharmaceutical development 药物开发39. q8(r2): pharm

20、aceutical development药物开发q9: quality risk management 质量风险管理40. q9:qualityriskmanagement 质量风险管理q10: pharmaceutical quality system 药物质量体系41. q10:pharmaceuticalqualitysystem药物质量体系qll： development and manufacture of drug substances 原料药的开发与制造42. qll:development and manufacture of drug substances (chemica

21、l entities and biotechnological/biological entities)原料药的开发与制造(化学实体与生物技术/生物制品实体)二、ich安全性部分(safety)s1a sic: carcinogenicity studies 致癌试验1 si a:guidelineontheneedforcarcinogenicitystudiesofpharmaceuticals 药物致癌试验的必要性2. s1b:testingforcarcinogenicityofpharmaceuticals 药物致癌试验3. s1 c(r2):doseselectionforcarc

22、inogenicitystudiesofpharmaceuticals 药物致癌试验的剂量选择s2 genotoxicity studies 遗传毒性4. s2(r 1):guidanceongenotoxicitytestinganddatalnterpretationforpharmaceutical slntendedforhumanuse人用药物的遗传毒性试验和数据分析指导原则s3as3b: toxicokinetics and pharmacokinetics毒物代谢动力学与药物代谢动 力学5. s3a:noteforguidanceontoxicokinetics:theasses

23、smentofsystemicexposureinto xicitystudies毒物代谢动力学指南的注释：毒性研究中全身暴露的评价6. s3b:pharmacokinetics:guidanceforrepeateddosetissuedistributionstudies 药物代谢动力学：重复给药的组织分布研究指导原则s4: toxicity testing 毒性试验7. s4:durationofchronictoxicitytestinginanimals(rodentandnonrodenttoxicityt esting)动物体内慢性毒性持续时间的检验(啮齿类和非啮齿类毒性试验)s

24、5: reproductive toxicology 生殖毒性8. s5(r2):detectionoftoxicitytoreproductionformedicinalproductsandtoxicitytom alefertility药品的生殖毒性检测及雄性生育力毒性s6: biotechnological products 生物技术产品9. s6:preclinicalsafetyevaluationofbiotechnology-derivedpharmaceuticals 生物技术药品的临床前安全性试验s7a s7b: pharmacology studies 药理学研究10.

25、s7a:safetypharmacologystudiesforhumanpharmaceuticals 人用药物的安全性药理研究11. s7b:thenon-clinicalevaluationofthepotentialfordelayedventricularrepolarization(qtintervalprolongation)byhumanpharmaceuticals 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s8: immunotoxicology studies 免疫毒理学研究12. s8:immunotoxicitystudiesforhumanph

26、armaceuticals人用药品的免疫毒理学研究s9:nonclinicai evaluation for anticancer pharmaceuticals 抗癌药物临床前评价13. s9:nonclinicalevaluationforanticancerpharmaceuticals抗癌药物的临床前评价s10: photosafety evaluation 光安全评价14. s10: photosafety evaluation of pharmaceuticals药物的光安全评价三、ich.临床部分(efficacy)el: clinical safety for drugs us

27、ed in long-term treatment长期治疗药物的临床 安全性1. el:theextentofpopulationexposuretoassessclinicalsafetyfordrugsintendedforl ong-termtreatmentofn life-threateningconditions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e2a e2f: pharmacovigilance 药物警戒2. e2a:definitionsandstandardsforexpeditedreporting快速报告的定义和标准3. e2c(r2):pe

28、riodicbenefit-riskevaluationreport上市药詁定期风险效益评估报告4. e2d:post-approvalsafetydatamanagement:definitionsandstandardsforexpeditedreporting批准后安全性数据管理：快速报告的定义和标准5. e2e:pharmacovigilancepianning 药物警戒计划6. e2f:developmentsafetyupdatereport 安全性更新报告e3: clinical study reports 临床研究报告7. e3:structureandcontentofcli

29、nicalstudyreports临床研究报告的结构与内容e4: dose-response studies 量效研究8. e4:dose-responseinfbrmationtosupportdrugregistration新跖注册所需量效关系的资料e5: ethnic factors 种族因素9. e5(rl):ethnicfactorsintheacceptabilityofforeignclinicaldata对国外临床研究资料的种族因素的可接受性e6: good clinical practice药品临床研究规范10. e6(r 1 ):goodclinicalpractice:c

30、onsolidatedguideline跖品临床研究规范(gcp) 一致性指导原则11. e6(r2): integrated addendum to ich e6(r1): guideline for good clinical practice e6(r1)整合的附录：药品临床研究规范指南e7: clinical trials in geriatric population 老年人群的临床研究12. e7:studiesinsupportofspecialpopulations:geriatrics老年人群的临床研究e8: general considerations for clinic

31、al trials 临床研究总则13. e8:generalconsiderationsforclinicaltrials临床研究总则e9: statistical principles for clinical trials 临床研究的统计原则14. e9:statisticalprinciplesforclinicaltrials临床研究统计原则e10: choice of control group in clinical trials 临床研究对照组的选择15. e1 orchoiceofcontrolgroupandrelatedlssuesinclinicaltrials 临床研究

32、对照组的选择及相关问题ell: clinical trials in pediatric population 儿童人群的临床研究16. el 1 :clinicalinvestigationofmedicinalproductsinthepediatricpopulation 儿童人群的临床研究e12: clinical evaluation by therapeutic category 按治疗分类的各类药物临床 评价17. e12: principles for clinical evaluation of new antihypertensive drugs 抗高血压新药的临床评价指导

33、原则e14: clinical evaluation ofqt qt 临床评价18. el4:theclinicalevaluationofqt/qtcintervalprolongationandproarrhythmic potentialfornon-antianhythmicdrugs非抗心律失常药物致qt/qtc间期延t及潜在心律失常作用的临床评价e15: definitions in pharmacogenetics / pharmacogenomics 遗传药理学/药物基 因组学的定义19. e15:definitionsforgenomicbiomarkers,pharmaco

34、genomics,pharmacogenetics,ge nomicdataandsamplecodingcategories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e16: qualification of genomic biomarkers 基因生物标记物的条件20. e16:biomarkersrelatedtodrugorbiotechnologyproductdevelopment:context,stru ctureandformatofqualificationsubmissions与药物或生物技术产品相关的生物标记物研发：屮请资料的内容、结

35、构和格 式e17: multi-regional clinical trials 多个地区临床试验21 e17: general principle on planning/designing multi-regional clinical trials 规划多地区临床试验的一般原则e18: genomic sampling 基因组抽样22. e18: guideline on genomic sampling and management of genomic data 基因组数据采集与管理的指导原则四、ich.综合部分(multidisciplinary)ml: meddra terminology 医学术语m2: electronic standards 电子标准m3: nonclinical safety studies 临床前安全性研究1. m3:guidanceonnonclinicalsafety