原料药CTD申报资料-详细目录内容

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麦田.守望

Module 1: Administrative Information and Prescribing Information
1.1 Table of Contents of the Submission Including Module 1
1.2 Documents Specific to Each Region (for example, application forms, prescribing information)
Module 2: Common Technical Document Summaries
2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary(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, dosage form)
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.R REGIONAL INFORMATION
2.4 Nonclinical Overview
2.4.1 Overview of the nonclinical testing strategy
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 Clinical Overview
2.5.1 Product Development 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 and Tabulated 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 (see Appendix 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 (see Appendix B)
2.6.5.1 Pharmacokinetics: Overview
2.6.5.2 Analytical Methods and Validation Reports*
2.6.5.3 Pharmacokinetics: Absorption after a Single Dose
2.6.5.4 Pharmacokinetics: Absorption after Repeated Doses
2.6.5.5 Pharmacokinetics: Organ Distribution
2.6.5.6 Pharmacokinetics: Plasma Protein Binding
2.6.5.7 Pharmacokinetics: Study in Pregnant or Nursing Animals
2.6.5.8 Pharmacokinetics: Other Distribution Study
2.6.5.9 Pharmacokinetics: Metabolism In Vivo
2.6.5.10 Pharmacokinetics: Metabolism In Vitro
2.6.5.11 Pharmacokinetics: Possible Metabolic Pathways
2.6.5.12 Pharmacokinetics: Induction/Inhibition of Drug-Metabolizing Enzymes
2.6.5.13 Pharmacokinetics: Excretion
2.6.5.14 Pharmacokinetics: Excretion into Bile
2.6.5.15 Pharmacokinetics: Drug-Drug Interactions
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 (including supportive toxicokinetics evaluation)
2.6.6.4 Genotoxicity
2.6.6.5 Carcinogenicity (including supportive toxicokinetics 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 (see Appendix B)
2.6.7.1 Toxicology: Overview
2.6.7.2 Toxicokinetics: Overview of Toxicokinetics Studies
2.6.7.3 Toxicokinetics: Overview of Toxicokinetics Data
2.6.7.4 Toxicology: Drug Substance
2.6.7.5 Single-Dose Toxicity
2.6.7.6 Repeat-Dose Toxicity: Non-Pivotal Studies
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 to Implantation (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, Including Maternal 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 Clinical Summary
2.7.1 Summary of Biopharmaceutic 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 Results Across 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 Results Across 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 Clinical Efficacy
2.7.3.2 Summary of Results of Individual Studies
2.7.3.3 Comparison and Analyses of Results Across Studies
2.7.3.3.1 Study Populations
2.7.3.3.2 Comparison of Efficacy Results of all Studies
2.7.3.3.3 Comparison of Results in Sub-populations
2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
2.7.3.5 Persistence of Efficacy and/or Tolerance Effects
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 and Narratives of Safety Studies
2.7.4.1.2 Overall Extent of Exposure
2.7.4.1.3 Demographic and Other Characteristics of 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, and Other 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 Operate Machinery 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 of Module 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 Drug Substance (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 Standards or Materials (name, manufacturer)
3.2.S.6 Container Closure System (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 and Composition of the Drug Product (name, dosage form)
3.2.P.2 Pharmaceutical Development (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 Drug Product (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 Standards or Materials (name, dosage form)
3.2.P.7 Container Closure System (name, dosage form)
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.R REGIONAL INFORMATION
3.3 Literature References
Module 4: Nonclinical Study Reports
4.1 Table of Contents of Module 4
4.2 Study Reports(见正文)
4.2.1 Pharmacology
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 Validation Reports (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 by species, by route)
4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)
4.2.3.3 Genotoxicity
4.2.3.3.1 In vitro
4.2.3.3.2 In vivo (including supportive toxicokinetics evaluations)
4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations)
4.2.3.4.1 Long-term studies (in order by species; including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)
4.2.3.4.2 Short- or medium-term studies (including range-finding studies that cannot appropriately be included under repeat-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) (If modified study designs are used, the following sub-headings should be modified accordingly.)
4.2.3.5.1 Fertility and early embryonic development
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 included elsewhere)
4.2.3.7.4 Dependence
4.2.3.7.5 Metabolites
4.2.3.7.6 Impurities
4.2.3.7.7 Other
4.3 Literature References
Module 5: Clinical Study Reports
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutic 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 – In Vivo Correlation Study Reports
5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports
5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies
5.3.2.3 Reports of Studies Using Other Human Biomaterials
5.3.3 Reports of Human Pharmacokinetic (PK) Studies
5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports
5.3.3.2 Patient PK and Initial Tolerability Study 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 Study Reports
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 Clinical Studies Pertinent to the Claimed Indication
5.3.5.2 Study Reports of Uncontrolled Clinical Studies
5.3.5.3 Reports of Analyses of Data from More than 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 Patient Listings
5.4 Literature References
从这个目录可以看得出，我们国家只推行了质量部分的申报文件采用CTD格式，即模块2的质量相关综述和模块3的质量相关文件（模块2中的2.3.S和2.3.P与模块3中的3.2.S和3.2.P）。

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