英文版-制剂立卷审查技术标准.doc

Technical Review Standard for Formulation P1.General Study Evaluation and Regulatory Requirement P1.6 Information of Innovator □Provided Launch Country □Launch/□First Import Time in China Manufacturer □Not provided△ P1.7 API P1.8Documents for Packing Materials P1.8.1Copies of approval documents of the primary packing materials P1.8.2 Specifications or the primary packing materials □Provided □Not provided△ □Provided □Not provided△ P1.9. Justification Whether or not provided reasonable justifications for the development of the generics: P1.9.1Safety and Effectiveness of API P1.9.2Dosage form P1.9.3 Strength □Yes □No★ □Yes □No★ □Yes □No★ P1.10Supplementary requirements in the clinical trial approval notice □Provided □Not provided△ □Not applicable P1.11 Reference Listed Drug (RLD) P1.11.1Whether or not conducted comparison study with RLD □Yes □No★ P1.11.2 Whether or not conducted comparison study with imported originator or localized manufactured originator □Yes □No(if yes)★□Not applicable (if not) P1.11.3Reference Drug is □Originator / Localized Originator □ Generics launched in ICH member countries □Others Label/Photos/Package Insert □Provided □Not provided△ P2. Manufacturing Process Study P2.1 Provided or not the following of all the excipients: ①Source ②COA ③Specification □Completely Provided □Partially provided/Not provided△ □Completely Provided □Partially provided/Not provided△ □Completely Provided □Partially provided/Not provided△ P2.2Whether or not established in-house specification for excipients □Yes □No△ □ Not applicable P2.3 Whether or not established in-house specification for API □Yes □No△ □ Not applicable P2.4Whether or