英文版制剂立卷审查技术标准.docVIP

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. J