1、ICH Guidelines,王震 2015-02-01,ICH Guidelines,說(shuō)明,ICH的論題主要分為四類(lèi)，因此ICH根據(jù)論題的類(lèi)別不同而進(jìn)行相應(yīng)的編碼分類(lèi)： “Q”類(lèi)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。 “S”類(lèi)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。 3. “E”類(lèi)論題：E代表EFFICACY，指那些與人類(lèi)臨床研究相關(guān)的課題。 4. “M”類(lèi)論題：M代表MULTIDISCIPLINARY, 指那些不可單獨(dú)劃入以上三個(gè)分類(lèi)的交叉涉及的論題。同時(shí)M又細(xì)分為5個(gè)小類(lèi) M1: 常用醫(yī)學(xué)名詞 （MedDRA）

2、M2: 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、Quality Guidelines 質(zhì)量研究指導(dǎo)原則,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 t

3、o pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.,Q1A - Q1F 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 Stability Testing : 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 Test

4、ing for New Dosage Forms新劑型的穩(wěn)定性試驗(yàn) Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and 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

5、數(shù)據(jù),Q2 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,Q3A - Q3D 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新制劑中的雜質(zhì) Q3C(R5) Impurities: Guideline for Residual Solvents雜質(zhì)：殘留溶劑指南 Q3D Guide

6、line for Elemental Impurities - NEW Q3D Implementation of Guideline for Elemental Impurities,Q4 - Q4B Pharmacopoeias藥典,Q4 Pharmacopoeias藥典 Q4A Pharmacopoeial Harmonisation藥典的協(xié)調(diào) Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions藥典內(nèi)容的評(píng)估及推薦為用于ICH地區(qū) Q4B Annex 1R1 Residu

7、e on Ignition/Sulphated Ash General Chapter附錄1 關(guān)于灼燒殘?jiān)?灰分 常規(guī)篇 Q4B Annex 2R1 Test for Extractable Volume of Parenteral Preparations General Chapter關(guān)于注射劑可提取容量測(cè)試 常規(guī)篇 Q4B Annex 3R1 Test for Particulate Contamination: Sub-Visible Particles General Chapter附錄3 關(guān)于顆粒污染物測(cè)試:不溶性微粒 常規(guī)篇 Q4B Annex 4AR1 Microbiologi

8、cal Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter,Q4 - Q4B Pharmacopoeias藥典,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: A

9、cceptance Criteria 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 Chapte

10、r,Q4 - Q4B Pharmacopoeias藥典,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

11、 General Chapter Q4B Annex 14 Bacterial Endotoxins Test General Chapter Q4B FAQs Frequently Asked Questions,Q5A - Q5E Quality of Biotechnological Products 生物技術(shù)產(chǎn)品的質(zhì)量,Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 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 Q

12、5B 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：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 Stability Testing of Biotechnological/Biological 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 Characterisation of Cell Substrates Used for Prod

13、uction of Biotechnological/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 in their 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,Q6A- Q6B Specifications規(guī)格,Q6A Specifications : Test Procedures and Acceptance Criteria for N

14、ew Drug Substances and New Drug Products: Chemical Substances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 for Biotechnological/ 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 Practice(原料藥GMP規(guī)范),Q7 Good Manufacturing Practice

15、Guide for Active Pharmaceutical Ingredients活性藥物成份的GMP指南 Q7 Q S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals;,S3A - S3B Toxicokinetics and Pharmacokinetics毒代動(dòng)力學(xué)和藥代動(dòng)力學(xué),S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S

16、3A Q&AsQuestions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies,S4 Toxicity Testing毒性試驗(yàn),S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rode

17、nt Toxicity Testing),S5 Reproductive Toxicology生殖毒理學(xué),S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility,S6 Biotechnological Products生物技術(shù)制品,S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals,S7A - S7B Pharmacology Studies藥理學(xué)研究,S

18、7A Safety Pharmacology Studies for Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals,S8 Immunotoxicology Studies免疫毒理學(xué)研究,S8 Immunotoxicity Studies for Human Pharmaceuticals人類(lèi)的藥物免疫毒性研究,S9 No

19、nclinical Evaluation for Anticancer Pharmaceuticals抗癌藥物非臨床評(píng)價(jià),S9 Nonclinical Evaluation for Anticancer Pharmaceuticals S9 Q&AsQuestions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals,S10 Photosafety Evaluation光安全評(píng)價(jià),S10 Photosafety Evaluation of Pharmaceuticals藥物的光安全評(píng)價(jià),S11 Nonclini

20、cal Safety Testing非臨床安全性試驗(yàn),S11Nonclinical Safety Testing in Support of Development of Paediatric Medicines,Cross-cutting Topics,Cross-cutting Guidelines Some ICH Products do not fit uniquely into one of the Quality, Safety or Efficacy categories. Those Products can be found under theMulidisciplinary

21、Section.,三、Efficacy Guidelines 有效性評(píng)價(jià)指導(dǎo)原則,The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics tec

22、hniques to produce better targeted medicines,E1 Clinical Safety for Drugs used in Long-Term Treatment用于長(zhǎng)期治療藥物的臨床安全性,E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions要評(píng)估用于非危及生命的疾病的長(zhǎng)期治療藥物的臨床安全性人群暴露程度,E2A - E2F P

23、harmacovigilance藥物警戒,E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B(R3) IWGImplementation: Electronic Transmission of Individual Case Safety Reports E

24、2C(R2) Periodic Benefit-Risk Evaluation Report,E2C(R2) -E2F,E2C(R2) Q&AsQuestions & Answers: Periodic Benefit-Risk Evaluation Report E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning E2F Development Safety Update Report,E3 Clin

25、ical Study Reports臨床研究報(bào)告,E3 Structure and Content of Clinical Study Reports E3 Q&As R1Questions & Answers: Structure and Content of Clinical Study Reports,E4 Dose-Response Studies劑量反應(yīng)研究,E4 Dose-Response Information to Support Drug Registration支持藥品注冊(cè)的劑量反應(yīng)信息,E5 Ethnic Factors民族因素,E5(R1)Ethnic Factors

26、in the Acceptability of Foreign Clinical Data E5 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data,E6 Good Clinical Practice臨床試驗(yàn)規(guī)范,E6(R1)Good Clinical Practice E6(R2)Addendum: Good Clinical Practice,E7 Clinical Trials in Geriatric Population在老年人群中的臨床試驗(yàn),E7 St

27、udies in Support of Special Populations: Geriatrics E7 Q&AsQuestions & Answers: Studies in Support of Special Populations : Geriatrics,E8 General Considerations for Clinical Trials臨床試驗(yàn)的一般考慮,E8 General Considerations for Clinical Trials,E9 Statistical Principles for Clinical Trials臨床試驗(yàn)的統(tǒng)計(jì)學(xué)原理,E9 Stati

28、stical Principles for Clinical TrialsE9(R1)Addendum: Statistical Principles for Clinical Trials,E10 Choice of Control Group in Clinical Trials臨床試驗(yàn)中對(duì)照組的選擇,E10 Choice of Control Group and Related Issues in Clinical Trials在臨床試驗(yàn)中的對(duì)照組和相關(guān)問(wèn)題的選擇,E11 Clinical Trials in Pediatric Population在兒科臨床試驗(yàn),E11 Clinica

29、l Investigation of Medicinal Products in the Pediatric Population E11(R1)Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population,E12 Clinical Evaluation by Therapeutic Category治療類(lèi)別臨床評(píng)價(jià),E12 Principles for Clinical Evaluation of New Antihypertensive Drugs,E14 Clinical Evalua

30、tion臨床評(píng)價(jià),E14The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14 Q&As R2Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs,E15 Definitions in Pharmacogen

31、etics / Pharmacogenomics藥理學(xué)/藥物基因組學(xué)的定義,E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories,E16 Qualification of Genomic Biomarkers基因組生物標(biāo)志物的資格,E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and F

32、ormat of Qualification Submissions藥物或生物技術(shù)產(chǎn)品開(kāi)發(fā)相關(guān)的生物標(biāo)志物：上下文，結(jié)構(gòu)和資格文件格式,E17 Multi-Regional Clinical Trials多區(qū)域臨床試驗(yàn),E17 General principle on planning/designing Multi-Regional Clinical Trials在規(guī)劃/設(shè)計(jì)多區(qū)域臨床試驗(yàn)的一般原則,E18 Genomic Sampling Methodologies 基因組取樣方法,E18 Genomic Sampling Methodologies for Future Use,Cros

33、s-cutting Topics,Cross-cutting Guidelines,四、Multidisciplinary Guidelines多學(xué)科指南,Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).,M1 MedDRA Terminolog