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CTD格式申报资料提交要求 （药学部分：制剂——骨架篇）
目录
内容 3.2.P.1 3.2.P.2 3.2.P.2.1 3.2.P.2.1.1 3.2.P.2.1.2 3.2.P.2.2
3.2.P.2.2.1 3.2.P.2.2.2
3.2.P.2.2.3
3.2.P.2.3 3.2.P.2.4 3.2.P.2.5 3.2.P.2.6 3.2.P.3
3.2.P.3.1 3.2.P.3.2 3.2.P.3.3 3.2.P.3.4 3.2.P.3.5 3.2.P.4
3.2.P.4.1 3.2.P.4.2 3.2.P.4.3 3.2.P.4.4 3.2.P.4.5 3.2.P.4.6 3.2.P.5
3.2.P.5.1 3.2.P.5.2 3.2.P.5.3 3.2.P.5.4 3.2.P.5.5
3.2.P.5.6
3.2.P.6 3.2.P.7 3.2.P.8
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CCTD (China)
剂型及产品组成 产品开发 处方组成
原料药 辅料
制剂
处方开发过程 制剂相关特性
生产工艺开发 包装材料容器 相容性
生产 生产商 批处方
生产工艺和工艺控制关键步骤和中间体的控制
工艺验证和评价 辅料控制
制剂控制 质量标准 分析方法 分析方法验证 批检验报告 杂质分析 质量标准依据 对照品
稳定性
CTD (ICH)
Description and Composition of the Drug Product (name, dosage form) Pharmaceutical Development Components of the Drug Product Drug Substance Excipients Drug Product
Formulation Development Overages
Physicochemical and Biological Properties Manufacturing Process Development Container Closure System Microbiological attributes Compatibility Manufacture Manufacturer(s) Batch Formula
Description of Manufacturing Process and Process Controls
Controls of Critical Steps and Intermediates Process Validation and/or Evaluation Control of Excipients Specifications
Analytical procedures
Validation of analytical procedures Justification of specifications
Excipients of human or animal origin Novel excipients(ref to A 3) Control of Drug Product Specifications
Analytical procedures
Validation of analytical procedures Justification of specifications Characterisation of Impurities Justification of Specification(s) Reference Standards or Materials Container closure system Stability
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3.2.P.8.1 3.2.P.8.2 3.2.P.8.3
稳定性总结 上市后稳定性研究方案和承诺 稳定性数据
Stability Summary and Conclusion Post-approval Stability Protocol and Stability
Stability Data
个人定义
CTD：ICH的要求，英文水平所限，仅罗列上，没有核对。
CCTD：中国式CTD，主要来自CDE发布的讨论稿模板，和重庆培训的相关内容。
申报资料正文及撰写要求 3.2.P.1 剂型及产品组成
CTD
A description of the drug product and its composition should be provided. The information provided should include, for example: ? Description1 of the dosage form;
? Composition, i.e., list of all components of the dosage form, and their amount on a per-unit
basis (including overages, if any) the function of the components, and a reference to their quality standards (e.g., compendial monographs or manufacturer’s specifications) ? Description of accompanying reconstitution diluent(s); and
? Type of container and closure used for the dosage form and accompanying reconstitution
diluent, if applicable.
Reference ICH Guidelines: Q6A and Q6B CCTD：
(1) 说明具体的剂型，并以表格的方式列出单位剂量产品的处方组成，列明各成份在处方中的作用，执行的标准。如有过量加入的情况需给予说明。对于处方中用到但最终需去除的溶剂也应列出。 成份 工艺中使用到并最终去除的溶剂 用量 过量加入 作用 执行标准
1 For a drug product supplied with reconstitution diluent(s), the information on the
diluent(s) should be provided in a separate part “P”, as appropriate
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(2) 如附带专用溶剂，参照以上表格方式列出专用溶剂的处方。 (3) 说明产品所使用的包装材料及容器。 举例：
3.2.P.2 产品开发 CTD：
The Pharmaceutical Development section should contain information on the development studies conducted to establish that the dosage form, the formulation, manufacturing process, container closure system, microbiological attributes and usage instructions are appropriate for the purpose specified in the application. The studies described here are distinguished from routine control tests conducted according to specifications. Additionally, this section should identify and describe the formulation and process attributes (critical parameters) that can influence batch reproducibility, product performance and drug product quality. Supportive data and results from specific studies or published literature can be included within or attached to the Pharmaceutical Development section. Additional supportive data can be referenced to the relevant nonclinical or clinical sections of the application. Reference ICH Guidelines: Q6A and Q6B CCTD
提供相关的研究资料或文献资料来论证剂型、处方组成、生产工艺、包装材料选择和确定的合理性，具体为：
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