01日本全套CTD申报资料目录(详细)
CTD格式申报资料目录、化学药品申报资料项目（附件二格式）（5篇范例）
CTD格式申报资料目录、化学药品申报资料项目（附件二格式）（5篇范例）第一篇：CTD格式申报资料目录、化学药品申报资料项目(附件二格式)附件：原料药CTD格式申报资料目录管理信息资料：审查意见表/受理通知书（进口申请）；药品注册现场核查报告；药品注册现场检查报告；药品注册检验报告申请表；药品研制情况申报表；药品注册现场检查申请表综述资料（文件夹名）1.药品名称。
2.证明性文件。
3.立题目的与依据。
4.对主要研究结果的总结及评价。
5.药品说明书、起草说明及相关参考文献。
6.包装、标签设计样稿。
信息汇总表（文件夹名）信息汇总表资料药学资料（文件夹名）1.基本信息（3.2.S.1）生产信息（3.2.S.2）3.特性鉴定（3.2.S.3）4.原料药的质量控制（3.2.S.4）5.对照品（3.2.S.5）6.包装材料和容器（3.2.S.6）7.稳定性（3.2.S.7）药理毒理研究资料（文件夹名）16.药理毒理研究资料综述。
17.主要药效学试验资料及文献资料。
18.一般药理学的试验资料及文献资料。
19.急性毒性试验资料及文献资料。
20.长期毒性试验资料及文献资料。
21.过敏性（局部、全身和光敏毒性）、溶血性和局部（血管、皮肤、粘膜、肌肉等）刺激性等特殊安全性试验资料和文献资料。
22.复方制剂中多种成份药效、毒性、药代动力学相互影响的试验资料及文献资料。
23.致突变试验资料及文献资料。
24.生殖毒性试验资料及文献资料。
25.致癌试验资料及文献资料。
26.依赖性试验资料及文献资料。
27.非临床药代动力学试验资料及文献资料。
临床试验资料（文件夹名）案。
30.临床研究者手册。
31.知情同意书样稿、伦理委员会批准件。
32.临床试验报告。
二、制剂CTD格式申报资料电子提交目录管理信息资料：审查意见表/受理通知书（进口申请）；药品注册现场核查报告；药品注册现场检查报告；药品注册检验报告申请表；药品研制情况申报表；药品注册现场检查申请表综述资料（文件夹名）1.药品名称。
ctd格式申报资料模板
（3）ICH的CTD格式申报资料要求
• 目的 统一三方申报资料的格式要求，避免重复劳动 • 资料结构 第一部分：各国的特殊要求（证明材料等） 第二部分：各专业的综述 第三部分：具体的研究资料与图片等 • 特点 条理清晰、资料编码科学、方便审评与国际间的 交流
2.国内起草背景
• 国内存在的问题 对申报资料的要求不够细化 企业水平参差不齐 申报资料的质量总体较差 审评人员的工作量大，且包括很多不必要的 打字工作。 审评报告的重点信息缺失 • 解决的思路 照国外，规范申报资料，提倡电子提交， 审评报告与综述资料有机结合。
质控：分析方法的验证与对照品的标定
稳定性：样品情况、结果的表述
综述中关键点（2）
• 制剂 处方工艺：研发过程、变化情况及批次 汇总表（代表性批次 ） 质量控制 ：放行标准、有关物质方法学 验证应针对已知杂质、列明产品中可能 含有的杂质、对照品的标定 稳定性：上市后的承诺和方案、使用中 产品稳定性、相容性试验
三、总结
• 满足临床治疗与患者需求是药品研发立题 的主要依据。 • 质量源于设计：药品研发的质量决定了药 品的质量。 • 申报资料是注册时证明药品安全有效、质 量可控的重要依据。 • CTD格式的申报资料充分体现了药品研发 的系统性，对指导研发、注册申报，提高 审评的质量与效率均有重要意义。
国内外质量标准杂质检查项对比
起草过程与特点
• 2009年开始启动 • 周密安排、全员参与 制定了详细的工作计划（中心与各小组 层面），全体化药药学人员参与讨论 • 广泛征求意见 多种形式多方征求意见 • 2010年9月正式发布 国食药监注 〔2010〕 387 号
国家局对有关事项的通知
一、化药注册分类3、4、5和6的生产注册申请的 药学部分申报资料，可参照CTD格式提交，同 时提交电子版。 二、化药注册分类1和2的药学资料，暂不按CTD 格式提交资料。 三、为鼓励CTD格式提交，并稳步推进： （一）按《药品注册管理办法》附件2申报资料 要求提交的生产注册申请申报资料仍予接收。 （二）技术审评部门将对提交CTD格式申报资 料的注册申请单独按序进行审评。
CTD格式目录 ICH CTD-Table of Content
Table of Content of ICH CTDModule 1: Administrative Information and Prescribing Information (1)Module 2: Common Technical Document Summaries (1)Module 3: Quality (5)Module 4: Nonclinical Study Reports (6)Module 5: Clinical Study Reports (8)Module 1: Administrative Information and Prescribing Information1.1 Table of Contents of the Submission Including Module 11.2 Documents Specific to Each Region (for example, application forms, prescribing information)Module 2: Common Technical Document Summaries2.1 Common Technical Document Table of Contents (Modules 2-5)2.2 CTD Introduction2.3 Quality Overall Summary(QOS)INTRODUCTION2.3.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 APPENDICES2.3.A.1 Facilities and Equipment (name, manufacturer)2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)2.3.A.3 Excipients2.3.R REGIONAL INFORMATION2.4 Nonclinical Overview2.4.1 Overview of the nonclinical testing strategy2.4.2 Pharmacology2.4.3 Pharmacokinetics2.4.4 Toxicology2.4.5 Integrated overview and conclusions2.4.6 List of literature references2.5 Clinical Overview2.5.1 Product Development Rationale2.5.2 Overview of Biopharmaceutics2.5.3 Overview of Clinical Pharmacology2.5.4 Overview of Efficacy2.5.5 Overview of Safety2.5.6 Benefits and Risks Conclusions2.5.7 Literature References2.6 Nonclinical Written and Tabulated Summaries PharmacologyPharmacokineticsToxicology2.6.1 Introduction2.6.2 Pharmacology Written Summary2.6.2.1 Brief Summary2.6.2.2 Primary Pharmacodynamics2.6.2.3 Secondary Pharmacodynamics2.6.2.4 Safety Pharmacology2.6.2.5 Pharmacodynamic Drug Interactions2.6.2.6 Discussion and Conclusions2.6.2.7 Tables and Figures2.6.3 Pharmacology Tabulated Summary (see Appendix B)2.6.3.1 Pharmacology: Overview2.6.3.2 Primary Pharmacodynamics*2.6.3.3 Secondary Pharmacodynamics*2.6.3.4 Safety Pharmacology2.6.3.5 Pharmacodynamic Drug Interactions*2.6.4 Pharmacokinetics Written Summary2.6.4.1 Brief Summary2.6.4.2 Methods of Analysis2.6.4.3 Absorption2.6.4.4 Distribution2.6.4.5 Metabolism (interspecies comparison)2.6.4.6 Excretion2.6.4.7 Pharmacokinetic Drug Interactions2.6.4.8 Other Pharmacokinetic Studies2.6.4.9 Discussion and Conclusions2.6.4.10 Tables and Figures2.6.5 Pharmacokinetics Tabulated Summary (see Appendix B)2.6.5.1 Pharmacokinetics: Overview2.6.5.2 Analytical Methods and Validation Reports*2.6.5.3 Pharmacokinetics: Absorption after a Single Dose2.6.5.4 Pharmacokinetics: Absorption after Repeated Doses2.6.5.5 Pharmacokinetics: Organ Distribution2.6.5.6 Pharmacokinetics: Plasma Protein Binding2.6.5.7 Pharmacokinetics: Study in Pregnant or Nursing Animals2.6.5.8 Pharmacokinetics: Other Distribution Study2.6.5.9 Pharmacokinetics: Metabolism In Vivo2.6.5.10 Pharmacokinetics: Metabolism In Vitro2.6.5.11 Pharmacokinetics: Possible Metabolic Pathways2.6.5.12 Pharmacokinetics: Induction/Inhibition of Drug-Metabolizing Enzymes2.6.5.13 Pharmacokinetics: Excretion2.6.5.14 Pharmacokinetics: Excretion into Bile2.6.5.15 Pharmacokinetics: Drug-Drug Interactions2.6.5.16 Pharmacokinetics: Other2.6.6 Toxicology Written Summary2.6.6.1 Brief Summary2.6.6.2 Single-Dose Toxicity2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)2.6.6.4 Genotoxicity2.6.6.5 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 Tolerance2.6.6.8 Other Toxicity Studies (if available)2.6.6.9 Discussion and Conclusions2.6.6.10 Tables and Figures2.6.7 Toxicology Tabulated Summary (see Appendix B)2.6.7.1 Toxicology: Overview2.6.7.2 Toxicokinetics: Overview of Toxicokinetics Studies2.6.7.3 Toxicokinetics: Overview of Toxicokinetics Data2.6.7.4 Toxicology: Drug Substance2.6.7.5 Single-Dose Toxicity2.6.7.6 Repeat-Dose Toxicity: Non-Pivotal Studies2.6.7.7 Repeat-Dose Toxicity: Pivotal Studies2.6.7.8 Genotoxicity: In Vitro2.6.7.9 Genotoxicity: In Vivo2.6.7.10 Carcinogenicity2.6.7.11 Reproductive and Developmental Toxicity: Non-Pivotal Studies2.6.7.12 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 Animalsa2.6.7.16 Local Tolerance2.6.7.17 Other Toxicity Studies2.7 Clinical Summary2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods2.7.1.1 Background and Overview2.7.1.2 Summary of Results of Individual Studies2.7.1.3 Comparison and Analyses of Results Across Studies2.7.1.4 Appendix2.7.2 Summary of Clinical Pharmacology Studies2.7.2.1 Background and Overview2.7.2.2 Summary of Results of Individual Studies2.7.2.3 Comparison and Analyses of Results Across Studies2.7.2.4 Special Studies2.7.2.5 Appendix2.7.3 Summary of Clinical Efficacy2.7.3.1 Background and Overview of Clinical Efficacy2.7.3.2 Summary of Results of Individual Studies2.7.3.3 Comparison and Analyses of Results Across Studies2.7.3.3.1 Study Populations2.7.3.3.2 Comparison of Efficacy Results of all Studies2.7.3.3.3 Comparison of Results in Sub-populations2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations2.7.3.5 Persistence of Efficacy and/or Tolerance Effects2.7.3.6 Appendix2.7.4 Summary of Clinical Safety2.7.4.1 Exposure to the Drug2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies2.7.4.1.2 Overall Extent of Exposure2.7.4.1.3 Demographic and Other Characteristics of Study Population2.7.4.2 Adverse Events2.7.4.2.1 Analysis of Adverse Events2.7.4.2.2 Narratives2.7.4.3 Clinical Laboratory Evaluations2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety2.7.4.5 Safety in Special Groups and Situations2.7.4.5.1 Intrinsic Factors2.7.4.5.2 Extrinsic Factors2.7.4.5.3 Drug Interactions2.7.4.5.4 Use in Pregnancy and Lactation2.7.4.5.5 Overdose2.7.4.5.6 Drug Abuse2.7.4.5.7 Withdrawal and Rebound2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of MentalAbility2.7.4.6 Post-marketing Data2.7.4.7 Appendix2.7.5 Literature References2.7.6 Synopses of Individual StudiesModule 3: Quality3.1 Table of Contents of Module 33.2 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 APPENDICES3.2.A.1 Facilities and Equipment (name, manufacturer)3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)3.2.A.3 Excipients3.2.R REGIONAL INFORMATION3.3 Literature ReferencesModule 4: Nonclinical Study Reports4.1 Table of Contents of Module 44.2 Study Reports(见正文)4.2.1 Pharmacology4.2.1.1 Primary Pharmacodynamics4.2.1.2 Secondary Pharmacodynamics4.2.1.3 Safety Pharmacology4.2.1.4 Pharmacodynamic Drug Interactions4.2.2 Pharmacokinetics4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available)4.2.2.2 Absorption4.2.2.3 Distribution4.2.2.4 Metabolism4 2.2.5 Excretion4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)4.2.2.7 Other Pharmacokinetic Studies4.2.3 Toxicology4.2.3.1 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 Genotoxicity4.2.3.3.1 In vitro4.2.3.3.2 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 studies4.2.3.5 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 development4.2.3.5.2 Embryo-fetal development4.2.3.5.3 Prenatal and postnatal development, including maternal function4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated.4.2.3.6 Local Tolerance4.2.3.7 Other Toxicity Studies (if available)4.2.3.7.1 Antigenicity4.2.3.7.2 Immunotoxicity4.2.3.7.3 Mechanistic studies (if not included elsewhere)4.2.3.7.4 Dependence4.2.3.7.5 Metabolites4.2.3.7.6 Impurities4.2.3.7.7 Other4.3 Literature ReferencesModule 5: Clinical Study Reports5.1 Table of Contents of Module 55.2 Tabular Listing of All Clinical Studies5.3 Clinical Study Reports5.3.1 Reports of Biopharmaceutic Studies5.3.1.1 Bioavailability (BA) Study Reports5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports5.3.1.3 In Vitro – In Vivo Correlation Study Reports5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials5.3.2.1 Plasma Protein Binding Study Reports5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies5.3.2.3 Reports of Studies Using Other Human Biomaterials5.3.3 Reports of Human Pharmacokinetic (PK) Studies5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports5.3.3.2 Patient PK and Initial Tolerability Study Reports5.3.3.3 Intrinsic Factor PK Study Reports5.3.3.4 Extrinsic Factor PK Study Reports5.3.3.5 Population PK Study Reports5.3.4 Reports of Human Pharmacodynamic (PD) Studies5.3.4.1 Healthy Subject PD and PK/PD Study Reports5.3.4.2 Patient PD and PK/PD Study Reports5.3.5 Reports of Efficacy and Safety Studies5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication5.3.5.2 Study Reports of Uncontrolled Clinical Studies5.3.5.3 Reports of Analyses of Data from More than One Study5.3.5.4 Other Study Reports5.3.6 Reports of Post-Marketing Experience5.3.7 Case Report Forms and Individual Patient Listings5.4 Literature ReferencesANNEX : Granularity Document参考ICH guidelines：M4E R1M4Q R1M4S R2。
CTD格式申报资料范本
药品注册分类：化学药品六类注册申请分类：仿制药品注册申请药品名称：苯磺酸氨氯地平片（XX g、XX g）资料项目名称：药学研究CTD格式申报资料研究机构名称：XXX制药有限公司研究机构地址：XXXXXXXXX研究机构主要研究者：XXX研究机构电话：XXX注册申请联系人姓名：XXX原始资料的保存地点：XXX制药有限公司注册申请机构联系电话：XXXXXXXXX药品注册申请人：XXX制药有限公司苯磺酸氨氯地平片申报资料（药学部分）目录3.2.P.1 剂型及产品组成 (3)3.2.P.2 产品开发 (4)3.2.P.2.1 处方组成 (4)3.2.P.2.1.1 原料药 (4)3.2.P.2.1.2 辅料 (5)3.2.P.2.2 制剂研究 (5)3.2.P.2.2.1 处方开发过程 (5)3.2.P.2.3 生产工艺的开发 (20)3.2.P.2.4 包装材料/容器 (23)2.3.P.2.5 相容性 (23)3.2.P.3 生产 (23)3.2.P.3.1生产商 (23)3.2.P.3.2批处方 (23)3.2.P.3.3 生产工艺和工艺控制 (24)3.2.P.3.4 关键步骤和中间体的控制 (25)3.2.P.3.5 工艺验证和评价 (26)3.2.P.4 原辅料的控制 (31)3.2.P.5 制剂的质量控制 (31)3.2.P.5.1质量标准 (31)3.2.P.5.2 分析方法 (31)3.2.P.5.3 分析方法的验证 (34)3.2.P.5.4 批检验报告 (93)3.2.P.5.5 杂质分析 (97)3.2.P.6 对照品 (100)3.2.P.7 稳定性 (101)3.2.P.7.1稳定性总结 (101)3.2.P.7.2上市后的稳定性承诺和稳定性方案 (102)3.2.P.7.3 稳定性数据 (102)申报资料正文3.2.P.1 剂型及产品组成苯磺酸氨氯地平片是一种独特的具有高度血管选择性的长效二氢吡啶类钙离子拮抗剂，是心血管治疗药物中比较理想的长效降压药，也是近几年来世界处方量最大的高血压和心绞痛治疗药物。
CTD申报资料-质量部分
生产过程的控制和检验
总结词
生产过程的控制和检验是保证产品质量的重要环节，它涉及到生产过程中的质 量控制和产品检验。
详细描述
企业应提供生产过程的控制文件，包括工艺流程图、操作规程、检验规程等。 同时，还应提供产品检验记录、不合格品处理记录等，以证明生产过程的有效 控制和产品的合格性。
产品质量的持续改进
批准流程和要求
行政审批
在技术评估通过后，监管机构进行行政审批，决定是否批准申请。
批准通知
如果申请获得批准，监管机构会发出正式的批准通知，告知申请人可以开始生产或进口 相关产品。
批准流程和要求
真实性
申报资料中的所有数据和信息必须真实可靠，不得有 任何虚假或误导性信息。
准确性
申报资料中的数据和信息必须准确无误，能够反映产 品的真实情况。
规范性
申报资料必须符合相关法 规、指导原则和格式要求， 确保资料的可读性和可理 解性。
一致性
申报资料中的信息必须一 致，避免出现矛盾或不一 致的情况。
批准流程和要求
申请
申请人需向相关监管机构提交CTD申报 资料，并缴纳相应的申请费用。
VS
技术评估
监管机构对申报资料进行技术评估，核实 资料的真实性、准确性和完整性。
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质量部分的审核和批准
审核流程和要求
初审
由专业审核人员对CTD申报资料进行初步审核，确保资料完整性、规范性和一致性。
复审
在初审通过后，进行更加细致的复审，包括对各项内容进行逐一核对，确保数据准确性和可靠性。
审核流程和要求
审核流程和要求
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02
03
完整性
申报资料必须完整，包括 所有必要的文件、表格和 证明材料。
CTD格式申报资料
CTD 格式申报资料撰写要求〔原料药〕一、目录原料药根本信息药品名称结构理化性质生产信息生产商生产工艺和过程控制物料控制要点步骤和中间体的控制工艺考据和议论生产工艺的开发特点判断结构和理化性质杂质原料药的质量控制质量标准解析方法解析方法的考据批检验报告质量标准拟定依照比较品包装资料和容器牢固性牢固性总结上市后牢固性承诺和牢固性方案牢固性数据二、申报资料正文及撰写要求根本信息药品名称供给原料药的中英文通用名、化学名，化学文摘〔 CAS〕号以及其他名称〔包括外国药典收载的名称〕。
结构供给原料药的结构式、分子式、分子量，如有立体结构和多晶型现象应特别说明。
理化性质供给原料药的物理和化学性质〔一般本源于药典和默克索引等〕，详细包括以下信息：性状(如外观，颜色，物理状态) ；熔点或沸点；比旋度，溶解性，溶液pH, 分配系数，解离常数，将用于制剂生产的物理形态〔如多晶型、溶剂化物、或水合物〕，粒度等。
生产信息生产商生产商的名称〔必然要写全称〕、地点、、以及生产场所的地点、、等。
生产工艺和过程控制〔1〕工艺流程图：按合成步骤供给工艺流程图，注明工艺参数和所用溶剂。
如为化学合成的原料药，还应供给其化学反响式，其中应包括初步原料、中间体、所用反响试剂的分子式、分子量、化学结构式。
（2〕工艺描述：按工艺流程来描述工艺操作，以注册批为代表，列明各反响物料的投料量及各步收率范围，明确要点生产步骤、要点工艺参数以及中间体的质控指标。
（3〕生产设备：供给主要和特别设备的型号及技术参数。
（4〕说明大生产的拟定批量范围。
物料控制依照工艺流程图中的工序，以表格的形式列明生产中用到的所有物料〔如初步物料、反响试剂、溶剂、催化剂等〕，并说明所使用的步骤。
比方以下：物料控制信息物料名称质量标准生产商使用步骤供给以上物料的质量控制信息，明确引用标准，或供给内控标准〔包括工程、检测方法和限度〕，并供给必要的方法学考据资料。
关于要点的初步原料，尚需依照相关技术指导原那么、技术要求供给其制备工艺资料。
CTD申报资料模版
CTD申报资料模版1. 介绍本文档提供了CTD申报资料的模版，帮助申请人编写CTD 申报资料。
CTD，即Common Technical Document，是国际上通用的药品注册申报文档格式。
CTD申报资料是药品注册申请的核心文档，用于向药品监管机构提交药品的安全性、有效性和质量等相关信息。
2. CTD申报资料的结构与内容CTD申报资料包含5个模块，分别是：质量部分（Quality）、非临床部分（Nonclinical）、临床部分（Clinical）、申请人概述部分（Applicant’s Overview）和审核员概述部分（Module 5）。
2.1 质量部分质量部分包括了药品的质量控制和生产工艺方面的信息，主要内容包括：•药品的质量规范（Specifications）•药品的制造工艺（Manufacturing Process）•药品的成分（Composition）•药品的稳定性研究（Stability Studies）•药品的包装和标签（Packaging and labeling）2.2 非临床部分非临床部分包含了药物的非临床研究数据，主要内容包括：•药物的药理学和毒理学研究（Pharmacology and Toxicology Studies）•药物代谢与药物动力学研究（Metabolism and Pharmacokinetics Studies）2.3 临床部分临床部分包含了药物的临床试验数据，主要内容包括：•临床试验设计（Clinical Trial Design）•临床试验结果（Clinical Trial Results）•药物在人群中的疗效（Efficacy）•药物的安全性（Safety）2.4 申请人概述部分申请人概述部分是申请人对药物的总结和解释，主要内容包括：•药物的概述和用途（Overview and Uses of the Drug）•为什么该药物是安全和有效的（Why the Drug is Safe and Effective）•药物的剂量和给药途径（Dosage andAdministration）•药物的不良反应（Adverse Reactions）2.5 审核员概述部分审核员概述部分是药品审评机构对申请资料的总结和评价，主要内容包括：•药物的总结和评价（Summary and Assessment of the Drug）•对申请人的要求和建议（Recommendations for the Applicant）•对药物的批准或拒绝的意见（Opinion on Approval or Rejection of the Drug）3. 编写CTD申报资料的注意事项在编写CTD申报资料时，需要注意以下几点：•按照CTD的结构和内容编写，确保包含了所有必要的信息。
CTD格式共性问题及申报资料全目录
CTD格式共性问题及申报资料全目录1. 合同目的本合同旨在双方确立CTD格式共性问题及申报资料的规范要求，以确保申报资料的准确性、一致性和规范性。
2. 定义2.1 “甲方”指合同签订方 A 公司。
2.2 “乙方”指合同签订方 B 公司。
3. 申报资料要求3.1 申报资料的组织和格式应符合国家相关法律法规和行业标准规定，以CTD （Common Technical Document）格式为基础。
3.2 甲方作为申请人，应按照CTD格式的要求提供以下申报资料：3.2.1 摘要提供申请的简要描述，包括产品名称、适应症、剂量等基本信息。
3.2.2 说明书提供产品的详细说明，包括药物成分、质量标准、适应症、剂量使用方法等相关信息。
3.2.3 质量文件提供产品的质量控制文件，包括药材和药品的质量标准、质量控制方法等。
3.2.4 临床试验资料提供产品的临床试验数据和药效研究报告，包括研究设计、试验结果、副作用等相关信息。
3.2.5 不良反应报告提供产品的不良反应报告，包括临床试验及市场上的不良事件报告。
3.2.6 生产工艺文件提供产品的生产工艺文件，包括生产工艺流程、原料选择、操作方法等。
3.3 乙方作为技术提供方，应协助甲方整理、审查和提交申报资料，并确保资料的准确性和完整性。
4. 保密条款甲方和乙方对于本合同项下所有的申报资料保持机密，并采取必要的措施保护资料的安全。
5. 条款变更除非双方协商一致，本合同条款不得进行任何修改或变更。
6. 解决争议本合同如发生争议，双方应友好协商解决；协商不成的，可向所在法院提起诉讼。
7. 生效日期和期限本合同自双方盖章之日起生效，有效期为三年。
甲方（盖章）：________________ 乙方（盖章）：________________签署日期：___________________1. 合同目的本合同旨在双方确立CTD格式共性问题及申报资料的规范要求，以确保申报资料的准确性、一致性和规范性。
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原薬 ····································································································· 1
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一般情報 ····························································································· 1
2.3.P 2.3.P.1 2.3.P.2 2.3.P.3 2.3.P.4 2.3.P.5 2.3.P.6 2.3.P.7 2.3.P.8
2.3.A 2.3.A.1 2.3.A.2 2.3.A.3
2.3.R
2.1 CTD の目次（第 2 部から第 5 部）
2.2 緒言
第 2 部における 記載箇所
Vol. Page
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添加剤 ································································································· 1
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各極の要求資料·················································································· 1
サムスカ錠 15 mg
医薬品製造販売承認申請書添付資料 第 2 部（資料概要）
2.1 CTD の目次（第 2 部から第 5 部）
大塚製薬株式会社
（2010 年 7 月）
1
2.2
2.3.S 2.3.S.1 2.3.S.2 2.3.S.3 2.3.S.4 2.3.S.5 2.3.S.6 2.3.S.7
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安全性薬理試験··················································································
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薬力学的薬物相互作用試験 ······························································
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安全性薬理試験··················································································
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薬力学的薬物相互作用試験 ······························································
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安全性の概括評価·············································································· 1
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ベネフィットとリスクに関する結論··············································· 1
2.6.4 2.6.4.1 2.6.4.2
第 2 部における 記載箇所
Vol. Page
2.4 非臨床試験の概括評価
非臨床試験の概括評価 ······································································ 1
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2.5 臨床に関する概括評価
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外来性感染性物質の安全性評価 ······················································ 1
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効力を裏付ける試験 ··········································································
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副次的薬理試験··················································································
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原薬の管理 ························································································· 1
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標準品又は標準物質·········································································· 1
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まとめ ·································································································
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臨床薬理に関する概括評価 ······························································ 1
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生物薬剤学に関する概括評価 ·························································· 1
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2.1 CTD の目次（第 2 部から第 5 部）：第 2 部
2
2.4
2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6 2.5.7
2.6.1
2.6.2 2.6.2.1 2.6.2.2 2.6.2.3 2.6.2.4 2.6.2.5 2.6.2.6 2.6.2.7
2.6.3 2.6.3.1 2.6.3.2 2.6.3.3 2.6.3.4 2.6.3.5
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考察及び結論······················································································
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図表 ·····································································································
77
参考文献 ····························································································· 1
83
2.6 非臨床試験の概要文及び概要表
緒言 ·····································································································
4
製造 ····································································································· 1
11
特性 ····································································································· 1