ICH 指導(dǎo)原則文件目錄(中英文)

1、人用藥品注冊(cè)技術(shù)要求國(guó)際協(xié)調(diào)會(huì)（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：“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。“S”類論題：S 代表 SAFETY，指那些與實(shí)驗(yàn)室和動(dòng)物實(shí)驗(yàn)，臨床前研究方面的相關(guān)的論題?！癊”類論題：E 代表 EFFICACY，指那些與人類臨床研究相關(guān)的課題。“M”類論題：M 代表 MULTIDISCIPLINARY,指那些不可單獨(dú)劃入以上三個(gè)分類的交叉涉及的論題。同時(shí) M 又細(xì)分為 5 個(gè)小類：M1: 常用醫(yī)學(xué)名詞（Med DRA） M2:

2、 藥政信息傳遞之電子標(biāo)準(zhǔn)M3: 與臨床試驗(yàn)相關(guān)的臨床前研究時(shí)間的安排M4: 常規(guī)技術(shù)文件(CTD)M5: 藥物詞典的數(shù)據(jù)要素和標(biāo)準(zhǔn)一、ICH.質(zhì)量部分（Quality） 穩(wěn)定性Quality 質(zhì)量Q1: Stability 穩(wěn)定性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)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)Q1C: Stability Testing for New

3、Dosage Forms 新劑型的穩(wěn)定性試驗(yàn)Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances a nd Drug Products原料藥和制劑穩(wěn)定性試驗(yàn)的交叉和矩陣設(shè)計(jì) Q1E: Evaluation of Stability Data 穩(wěn)定性數(shù)據(jù)的評(píng)估Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在氣候帶 III 和 IV，藥物注冊(cè)申請(qǐng)所提供的穩(wěn)定性數(shù)據(jù)Q2:

4、Analytical Validation 分析驗(yàn)證Q2(R1): Validation of Analytical Procedures: Text and Methodology分析程序的驗(yàn)證：正文及方法論Q3: Impurities 雜質(zhì)Q3A(R2): Impurities in New Drug Substances 新原料藥中的雜質(zhì)Q3B(R2): Impurities in New Drug Products (Revised Guideline) 新制劑中的雜質(zhì)Q3C(R3): Impurities: Guideline for Residual Solvents 雜質(zhì)：殘留溶

5、劑指南Impurities: Guideline for Residual Solvents (Maintenance) 雜質(zhì)：殘留溶劑指南(保留)PDE for Tetrahydrofuran (in Q3C(R3)四氫呋喃的日允許接觸劑量PDE for N-Methylpyrrolidone (in Q3C(R3)N-甲基吡咯烷酮的日允許接觸劑量Q4: Pharmacopoeias 藥典Q4A: Pharmacopoeial Harmonisation 藥典的協(xié)調(diào)Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for U

6、se in the IC H Regions藥典內(nèi)容的評(píng)估及推薦為用于 ICH 地區(qū)Q4B Annex1 Evaluation and Recommendation of Pharmacopoeial Texts for Use i n the ICH Regionson Residue on Ignition/Sulphated Ash General Chapter附錄 1 藥典內(nèi)容的評(píng)估及推薦為用于 ICH 地區(qū)關(guān)于灼燒殘?jiān)?灰分常規(guī)篇Q4B Annex2 Evaluation and Recommendation of Pharmacopoeial Texts for Use i n

7、the ICH Regionson Test for Extractable Volume of Parenteral Preparations General Chapter 附錄 2 藥典內(nèi)容的評(píng)估及推薦為用于 ICH 地區(qū)關(guān)于注射劑可提取容量測(cè)試常規(guī)篇Q4B Annex3 Evaluation and Recommendation of Pharmacopoeial Texts for Use i n the ICH Regionson Test for Particulate Contamination: Sub-Visible Particles General Chapter附錄

8、3 藥典內(nèi)容的評(píng)估及推薦為用于 ICH 地區(qū)關(guān)于顆粒污染物測(cè)試:不溶性微粒常規(guī)篇Q5: Quality of Biotechnological Products 生物技術(shù)制品質(zhì)量Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lin es of Human or Animal Origin來(lái)源于人或者動(dòng)物細(xì)胞系的生物技術(shù)產(chǎn)品的病毒安全性評(píng)估Q5B: Quality of Biotechnological Products: Analysis of the Expression Constr

9、uct i n Cells Used for Production of r-DNA Derived Protein Products生物技術(shù)產(chǎn)品的質(zhì)量：源于重組 DNA 的蛋白質(zhì)產(chǎn)品的生產(chǎn)中所用的細(xì)胞中的表達(dá)構(gòu)建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/B iological Products生物技術(shù)產(chǎn)品的質(zhì)量：生物技術(shù)/生物產(chǎn)品的穩(wěn)定性試驗(yàn)Q5D: Derivation and Characterization of Cell Substrates Used for

10、Production of Bi otechnological/Biological Products用于生產(chǎn)生物技術(shù)/生物產(chǎn)品的細(xì)胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes inTheir Manufacturing Process基于不同生產(chǎn)工藝的生物技術(shù)產(chǎn)品/生物產(chǎn)品的可比較性Q6: Specifications規(guī)格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Dr

11、ug Subst ances and New Drug Products: Chemical Substances (including decision trees)質(zhì)量規(guī)格：新原料藥和新制劑的檢驗(yàn)程序和可接收標(biāo)準(zhǔn)：化學(xué)物質(zhì)(包括決定過(guò)程)Q6B: Specifications: Test Procedures and Acceptance Criteria forBiotechnological/Biological Products質(zhì)量規(guī)格：生物技術(shù)/生物產(chǎn)品的檢驗(yàn)程序和可接收標(biāo)準(zhǔn)Q7: Good Manufacturing Practices （GMP）Q7A: Good Manufa

12、cturing Practice Guide for Active Pharmaceutical Ingredients活性藥物成份的 GMP 指南Q8: Pharmaceutical Development藥物研發(fā)Annex to Q8 Q8 附錄Q9: Quality Risk Management質(zhì)量風(fēng)險(xiǎn)管理Q10: Pharmaceutical Quality System藥物質(zhì)量體系二、ICH.安全性部分(Safety) 致癌試驗(yàn)S1A Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals 藥物致癌試

13、驗(yàn)的必要性S1B Testing for Carcinogenicity of Pharmaceuticals 藥物致癌試驗(yàn)S1C(R2)Dose Selection for Carcinogenicity Studies of Pharmaceuticals 藥物致癌試驗(yàn)的劑量選擇S1C藥物致癌試驗(yàn)的劑量選擇的附件：補(bǔ)充劑量限度和有關(guān)注釋 遺傳毒性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

14、導(dǎo)原則S2A 藥物審評(píng)遺傳毒性試驗(yàn)的特殊性指導(dǎo)原則S2B 遺傳毒性：藥物遺傳毒性試驗(yàn)標(biāo)準(zhǔn)組合藥代S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies 毒代動(dòng)力學(xué)指導(dǎo)原則：毒性研究中全身暴露的評(píng)價(jià)S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies藥代動(dòng)力學(xué)：重復(fù)給藥的組織分布研究指導(dǎo)原則慢性毒性S4 Duration of Chronic Toxicity

15、Testing in Animals (Rodent and Non Rodent Toxicity Testing) 動(dòng)物慢性毒性試驗(yàn)的周期（嚙齒類和非嚙齒類） 生殖毒性S5(R2)Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility (the Addendum dated November 1995 has been incorporated into the core guideline in November 2005 )S5A 藥品的生殖毒性檢測(cè)S5B 雄

16、性生育力毒性其他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 Safety Pharmacology Studies for Human Pharmaceuticals人用藥物的安全性藥理研究S7B The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceut

17、icals 人用藥延遲心室復(fù)極化（QT 間期延長(zhǎng)）潛在作用的非臨床評(píng)價(jià)指導(dǎo)原則S8 Immunotoxicity Studies for Human Pharmaceuticals 人類藥品的免疫毒性研究S9 Nonclinical Evaluation for Anticancer Pharmaceuticals 抗癌藥物的臨床前評(píng)價(jià)S10 Photosafety Evaluation三、ICH.臨床部分(Efficacy)E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for

18、 Long-Term Treatment of Non-Life-Threatening Conditions 評(píng)價(jià)臨床長(zhǎng)期給藥方案的安全性E2A Definitions and Standards for Expedited Reporting 快速報(bào)告的定義和標(biāo)準(zhǔn)3.E2B(R3) Data Elements for Transmission of Individual Case Safety Reports 個(gè)體病例安全性報(bào)告?zhèn)鬟f的數(shù)據(jù)要素4.E2C Periodic Benefit-Risk Evaluation Report上市藥品定期安全性更新報(bào)告5.E2D Post-Approv

19、al 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(bào)告的定義和標(biāo)準(zhǔn)6.E2E Pharmacovigilance Planning 藥物警戒計(jì)劃E2F Development Safety Update ReportE3 Structure and Content of Clinical Study Reports 臨床研究報(bào)告的結(jié)構(gòu)與內(nèi)容9.E4 Dose-Response Information to Support Drug Registration 新藥注冊(cè)

20、所需量-效關(guān)系的資料E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data 對(duì)國(guó)外臨床研究資料的種族因素的可接受性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臨床試驗(yàn)的一般考慮E9 Stati

21、stical Principles for Clinical Trials臨床試驗(yàn)統(tǒng)計(jì)原則E10 Choice of Control Group and Related Issues in Clinical Trials 對(duì)照組的選擇16.E11 Clinical Investigation of Medicinal Products in the Pediatric Population 兒童人群的臨床研究E12 按治療分類的各類藥物臨床評(píng)價(jià)E12 Principles for Clinical Evaluation of New Antihypertensive DrugsE14 The

22、Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 非抗心律失常藥物致 QT/QTc間期延長(zhǎng)及潛在心律失常作用的臨床評(píng)價(jià)E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding CategoriesE16 Biomarkers Related to Drug or Biotec

23、hnology Product Development: Context,Structure and Format of Qualification Submissions四、ICH.綜合部分 (Multidisciplinary)M1 醫(yī)學(xué)術(shù)語(yǔ) Med DRAM2 Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1) companion document to E2B(R3) 注冊(cè)資料傳遞所需的電子代碼M3 Guidance on N

24、onclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals與臨床研究有關(guān)的臨床前研究的時(shí)間安排M4 Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (Edited with Numbering and Section Header Changes, September 2002). Including the Annex : the Gran