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首先带领大家熟悉一下ICH “通用技术文件”（CTD）要求，英文完整版如下：
Module 1:Administrative Information and Prescribing Information
1.1 Table of Contents of the SubmissionIncluding Module 1
1.2 Documents Specific to Each Region (forexample, application forms, prescribing information)
Module 2:Common Technical Document Summaries
2.1 CommonTechnical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality OverallSummary(QOS)
INTRODUCTION
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)
2.3.S.1 General Information (name, manufacturer)
2.3.S.2 Manufacture (name, manufacturer)
2.3.S.3 Characterisation (name, manufacturer)
2.3.S.4 Control of Drug Substance (name, manufacturer)
2.3.S.5 Reference Standards or Materials (name, manufacturer)
2.3.S.6 Container Closure System (name, manufacturer)
2.3.S.7 Stability (name, manufacturer).2.3.P DRUG PRODUCT (NAME,DOSAGE FORM)
2.3.P.1 Description and Composition of the Drug Product (name, dosage form)
2.3.P.2 Pharmaceutical Development (name, dosage form)
2.3.P.3 Manufacture (name, dosage form)
2.3.P.4 Control of Excipients (name, dosage form)
2.3.P.5 Control of Drug Product (name, dosage form)
2.3.P.6 Reference Standards or Materials (name, dosage form)
2.3.P.7 Container Closure System (name, dosageform)
2.3.P.8 Stability (name, dosage form)2.3.A APPENDICES
2.3.A.1 Facilities and Equipment (name,manufacturer)
2.3.A.2 Adventitious Agents Safety Evaluation(name, dosage form, manufacturer)
2.3.A.3 Excipients
2.3.RREGIONAL INFORMATION
2.4 Nonclinical Overview
2.4.1 Overview of the nonclinical testingstrategy
2.4.2 Pharmacology
2.4.3 Pharmacokinetics
2.4.4 Toxicology
2.4.5 Integrated overview and conclusions
2.4.6 List of literature references
2.5 ClinicalOverview
2.5.1 ProductDevelopment Rationale
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety
2.5.6 Benefits and Risks Conclusions
2.5.7 Literature References
2.6 Nonclinical Written andTabulated Summaries
Pharmacology
Pharmacokinetics
Toxicology
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.2.1 Brief Summary
2.6.2.2 Primary Pharmacodynamics
2.6.2.3 Secondary Pharmacodynamics
2.6.2.4 Safety Pharmacology
2.6.2.5 Pharmacodynamic Drug Interactions
2.6.2.6 Discussion and Conclusions
2.6.2.7 Tables and Figures
2.6.3 Pharmacology Tabulated Summary (seeAppendix B)
2.6.3.1 Pharmacology: Overview
2.6.3.2 Primary Pharmacodynamics*
2.6.3.3 Secondary Pharmacodynamics*
2.6.3.4 Safety Pharmacology
2.6.3.5 Pharmacodynamic Drug Interactions*
2.6.4 Pharmacokinetics Written Summary
2.6.4.1 Brief Summary
2.6.4.2 Methods of Analysis
2.6.4.3 Absorption
2.6.4.4 Distribution
2.6.4.5 Metabolism (interspecies comparison)
2.6.4.6 Excretion
2.6.4.7 Pharmacokinetic Drug Interactions
2.6.4.8 Other Pharmacokinetic Studies
2.6.4.9 Discussion and Conclusions
2.6.4.10 Tables and Figures
2.6.5 Pharmacokinetics Tabulated Summary (seeAppendix B)
2.6.5.1 Pharmacokinetics: Overview
2.6.5.2 Analytical Methods and ValidationReports*
2.6.5.3 Pharmacokinetics: Absorption after aSingle Dose
2.6.5.4 Pharmacokinetics: Absorption afterRepeated Doses
2.6.5.5 Pharmacokinetics: Organ Distribution
2.6.5.6 Pharmacokinetics: Plasma Protein Binding
2.6.5.7 Pharmacokinetics: Study in Pregnant orNursing Animals
2.6.5.8 Pharmacokinetics: Other DistributionStudy
2.6.5.9 Pharmacokinetics: Metabolism In Vivo
2.6.5.10 Pharmacokinetics: Metabolism In Vitro
2.6.5.11 Pharmacokinetics: Possible MetabolicPathways
2.6.5.12 Pharmacokinetics: Induction/Inhibitionof Drug-Metabolizing Enzymes
2.6.5.13 Pharmacokinetics: Excretion
2.6.5.14 Pharmacokinetics: Excretion into Bile
2.6.5.15 Pharmacokinetics: Drug-DrugInteractions
2.6.5.16 Pharmacokinetics: Other
2.6.6 Toxicology Written Summary
2.6.6.1 Brief Summary
2.6.6.2 Single-Dose Toxicity
2.6.6.3 Repeat-Dose Toxicity (includingsupportive toxicokinetics evaluation)
2.6.6.4 Genotoxicity
2.6.6.5 Carcinogenicity (including supportivetoxicokinetics evaluations)
2.6.6.6 Reproductive and Developmental Toxicity(including range-finding studies and supportive toxicokinetics evaluations)
2.6.6.7 Local Tolerance
2.6.6.8 Other Toxicity Studies (if available)
2.6.6.9 Discussion and Conclusions
2.6.6.10 Tables and Figures
2.6.7 Toxicology Tabulated Summary (seeAppendix B)
2.6.7.1 Toxicology: Overview
2.6.7.2 Toxicokinetics: Overview ofToxicokinetics Studies
2.6.7.3 Toxicokinetics: Overview ofToxicokinetics Data
2.6.7.4 Toxicology: Drug Substance
2.6.7.5 Single-Dose Toxicity
2.6.7.6 Repeat-Dose Toxicity: Non-PivotalStudies
2.6.7.7 Repeat-Dose Toxicity: Pivotal Studies
2.6.7.8 Genotoxicity: In Vitro
2.6.7.9 Genotoxicity: In Vivo
2.6.7.10 Carcinogenicity
2.6.7.11 Reproductive and Developmental Toxicity:Non-Pivotal Studies
2.6.7.12 Reproductive and Developmental Toxicity– Fertility and Early Embryonic Development toImplantation (Pivotal)
2.6.7.13 Reproductive and Developmental Toxicity– Effects on Embryo-Fetal Development (Pivotal)
2.6.7.14 Reproductive and Developmental Toxicity– Effects on Pre- and Postnatal Development, IncludingMaternal Function (Pivotal)
2.6.7.15 Studies in Juvenile Animalsa
2.6.7.16 Local Tolerance
2.6.7.17 Other Toxicity Studies
2.7 ClinicalSummary
2.7.1 Summary ofBiopharmaceutic Studies and Associated Analytical Methods
2.7.1.1 Background and Overview
2.7.1.2 Summary of Results of Individual Studies
2.7.1.3 Comparison and Analyses of ResultsAcross Studies
2.7.1.4 Appendix
2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview
2.7.2.2 Summary of Results of Individual Studies
2.7.2.3 Comparison and Analyses of ResultsAcross Studies
2.7.2.4 Special Studies
2.7.2.5 Appendix
2.7.3 Summary of Clinical Efficacy
2.7.3.1 Background and Overview of ClinicalEfficacy
2.7.3.2 Summary of Results of Individual Studies
2.7.3.3 Comparison and Analyses of ResultsAcross Studies
2.7.3.3.1 Study Populations
2.7.3.3.2 Comparison of Efficacy Results of allStudies
2.7.3.3.3 Comparison of Results in Sub-populations
2.7.3.4 Analysis of Clinical InformationRelevant to Dosing Recommendations
2.7.3.5 Persistence of Efficacy and/or ToleranceEffects
2.7.3.6 Appendix
2.7.4 Summary of Clinical Safety
2.7.4.1 Exposure to the Drug
2.7.4.1.1 Overall Safety Evaluation Plan andNarratives of Safety Studies
2.7.4.1.2 Overall Extent of Exposure
2.7.4.1.3 Demographic and Other Characteristicsof Study Population
2.7.4.2 Adverse Events
2.7.4.2.1 Analysis of Adverse Events
2.7.4.2.2 Narratives
2.7.4.3 Clinical Laboratory Evaluations
2.7.4.4 Vital Signs, Physical Findings, andOther Observations Related to Safety
2.7.4.5 Safety in Special Groups and Situations
2.7.4.5.1 Intrinsic Factors
2.7.4.5.2 Extrinsic Factors
2.7.4.5.3 Drug Interactions
2.7.4.5.4 Use in Pregnancy and Lactation
2.7.4.5.5 Overdose
2.7.4.5.6 Drug Abuse
2.7.4.5.7 Withdrawal and Rebound
2.7.4.5.8 Effects on Ability to Drive or OperateMachinery or Impairment of Mental Ability
2.7.4.6 Post-marketing Data
2.7.4.7 Appendix
2.7.5 Literature References
2.7.6 Synopses of Individual Studies
Module 3: Quality
3.1 Table of Contents ofModule 3
3.2 Body of Data(数据汇总)
3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)
3.2.S.1 General Information(name, manufacturer)
3.2.S.1.1 Nomenclature (name, manufacturer)
3.2.S.1.2 Structure (name, manufacturer)
3.2.S.1.3 General Properties (name, manufacturer)
3.2.S.2 Manufacture (name,manufacturer)
3.2.S.2.1 Manufacturer(s) (name, manufacturer)
3.2.S.2.2 Description of Manufacturing Process and Process Controls (name,manufacturer)
3.2.S.2.3 Control of Materials (name, manufacturer)
3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer)
3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)
3.2.S.2.6 Manufacturing Process Development (name, manufacturer)
3.2.S.3 Characterisation(name, manufacturer)
3.2.S.3.1 Elucidation of Structure and other Characteristics (name,manufacturer)
3.2.S.3.2 Impurities (name, manufacturer)
3.2.S.4 Control of DrugSubstance (name, manufacturer)
3.2.S.4.1 Specification (name, manufacturer)
3.2.S.4.2 Analytical Procedures (name, manufacturer)
3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer)
3.2.S.4.4 Batch Analyses (name, manufacturer)
3.2.S.4.5 Justification of Specification (name, manufacturer)
3.2.S.5 Reference Standardsor Materials (name, manufacturer)
3.2.S.6 Container ClosureSystem (name, manufacturer)
3.2.S.7 Stability (name,manufacturer)
3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer)
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name,manufacturer)
3.2.S.7.3 Stability Data (name, manufacturer)
3.2.P DRUG PRODUCT (NAME,DOSAGE FORM)
3.2.P.1 Description andComposition of the Drug Product (name, dosage form)
3.2.P.2 PharmaceuticalDevelopment (name, dosage form)
3.2.P.2.1 Components of the Drug Product (name, dosage form)
3.2.P.2.1.1 Drug Substance (name, dosage form)
3.2.P.2.1.2 Excipients (name, dosage form)
3.2.P.2.2 Drug Product (name, dosage form)
3.2.P.2.2.1 Formulation Development (name, dosage form)
3.2.P.2.2.2 Overages (name, dosage form)
3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)
3.2.P.2.3 Manufacturing Process Development (name, dosage form)
3.2.P.2.4 Container Closure System (name, dosage form)
3.2.P.2.5 Microbiological Attributes (name, dosage form)
3.2.P.2.6 Compatibility (name, dosage form)
3.2.P.3 Manufacture (name,dosage form)
3.2.P.3.1 Manufacturer(s) (name, dosage form)
3.2.P.3.2 Batch Formula (name, dosage form)
3.2.P.3.3 Description of Manufacturing Process and Process Controls (name,dosage form)
3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)
3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)
3.2.P.4 Control of Excipients(name, dosage form)
3.2.P.4.1 Specifications (name, dosage form)
3.2.P.4.2 Analytical Procedures (name, dosage form)
3.2.P.4.3 Validation of Analytical Procedures (name, dosage form)
3.2.P.4.4 Justification of Specifications (name, dosage form)
3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form)
3.2.P.4.6 Novel Excipients (name, dosage form)
3.2.P.5 Control of DrugProduct (name, dosage form)
3.2.P.5.1 Specification(s) (name, dosage form)
3.2.P.5.2 Analytical Procedures (name, dosage form)
3.2.P.5.3 Validation of Analytical Procedures (name, dosage form)
3.2.P.5.4 Batch Analyses (name, dosage form)
3.2.P.5.5 Characterisation of Impurities (name, dosage form)
3.2.P.5.6 Justification of Specification(s) (name, dosage form)
3.2.P.6 Reference Standardsor Materials (name, dosage form)
3.2.P.7 Container Closure System (name, dosageform)
3.2.P.8 Stability (name, dosage form)
3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name,dosage form)
3.2.P.8.3 Stability Data (name, dosage form)
3.2.A APPENDICES
3.2.A.1 Facilities and Equipment (name,manufacturer)
3.2.A.2 Adventitious Agents Safety Evaluation(name, dosage form, manufacturer)
3.2.A.3 Excipients
3.2.RREGIONAL INFORMATION
3.3 Literature References
Module 4: Nonclinical StudyReports
4.1 Table of Contents ofModule 4
4.2 Study Reports(见正文)
4.2.1Pharmacology
4.2.1.1 Primary Pharmacodynamics
4.2.1.2 Secondary Pharmacodynamics
4.2.1.3 Safety Pharmacology
4.2.1.4 Pharmacodynamic Drug Interactions
4.2.2 Pharmacokinetics
4.2.2.1 Analytical Methods and ValidationReports (if separate reports are available)
4.2.2.2 Absorption
4.2.2.3 Distribution
4.2.2.4 Metabolism
4 2.2.5 Excretion
4.2.2.6 Pharmacokinetic Drug Interactions(nonclinical)
4.2.2.7 Other Pharmacokinetic Studies
4.2.3 Toxicology
4.2.3.1 Single-Dose Toxicity (in order byspecies, by route)
4.2.3.2 Repeat-Dose Toxicity (in order byspecies, by route, by duration; including supportive toxicokineticsevaluations)
4.2.3.3 Genotoxicity
4.2.3.3.1 In vitro
4.2.3.3.2 In vivo (including supportivetoxicokinetics evaluations)
4.2.3.4 Carcinogenicity (including supportivetoxicokinetics evaluations)
4.2.3.4.1 Long-term studies (in order byspecies; including range-finding studies that cannot appropriately be includedunder repeat-dose toxicity or pharmacokinetics)
4.2.3.4.2 Short- or medium-term studies(including range-finding studies that cannot appropriately be included underrepeat-dose toxicity or pharmacokinetics)
4.2.3.4.3 Other studies
4.2.3.5 Reproductive and Developmental Toxicity(including range-finding studies and supportive toxicokinetics evaluations) (Ifmodified study designs are used, the following sub-headings should be modifiedaccordingly.)
4.2.3.5.1 Fertility and early embryonicdevelopment
4.2.3.5.2 Embryo-fetal development
4.2.3.5.3 Prenatal and postnatal development,including maternal function
4.2.3.5.4 Studies in which the offspring(juvenile animals) are dosed and/or further evaluated.
4.2.3.6 Local Tolerance
4.2.3.7 Other Toxicity Studies (if available)
4.2.3.7.1 Antigenicity
4.2.3.7.2 Immunotoxicity
4.2.3.7.3 Mechanistic studies (if not includedelsewhere)
4.2.3.7.4 Dependence
4.2.3.7.5 Metabolites
4.2.3.7.6 Impurities
4.2.3.7.7 Other
4.3Literature References
Module 5: Clinical StudyReports
5.1 Table of Contents of Module 5
5.2 Tabular Listing of AllClinical Studies
5.3 Clinical Study Reports
5.3.1 Reports ofBiopharmaceutic Studies
5.3.1.1 Bioavailability (BA) Study Reports
5.3.1.2 Comparative BA and Bioequivalence (BE)Study Reports
5.3.1.3 In Vitro – InVivo Correlation Study Reports
5.3.1.4 Reports of Bioanalytical and AnalyticalMethods for Human Studies
5.3.2 Reports of Studies Pertinent toPharmacokinetics Using Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports
5.3.2.2 Reports of Hepatic Metabolism and DrugInteraction Studies
5.3.2.3 Reports of Studies Using Other HumanBiomaterials
5.3.3 Reports of Human Pharmacokinetic (PK)Studies
5.3.3.1 Healthy Subject PK and InitialTolerability Study Reports
5.3.3.2 Patient PK and Initial TolerabilityStudy Reports
5.3.3.3 Intrinsic Factor PK Study Reports
5.3.3.4 Extrinsic Factor PK Study Reports
5.3.3.5 Population PK Study Reports
5.3.4 Reports of Human Pharmacodynamic (PD)Studies
5.3.4.1 Healthy Subject PD and PK/PD StudyReports
5.3.4.2 Patient PD and PK/PD Study Reports
5.3.5 Reports of Efficacy and Safety Studies
5.3.5.1 Study Reports of Controlled ClinicalStudies Pertinent to the Claimed Indication
5.3.5.2 Study Reports of Uncontrolled ClinicalStudies
5.3.5.3 Reports of Analyses of Data from Morethan One Study
5.3.5.4 Other Study Reports
5.3.6 Reports of Post-Marketing Experience
5.3.7 Case Report Forms and Individual PatientListings
5.4 Literature References
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