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目的:总结广东省变更药品内包材和有效期补充申请申报资料中存在的问题。方法:将审评中发现的问题进行分类整理,并对其中部分问题进行探讨。结果与结论:汇总了广东省变更药品内包材和有效期补充申请申报资料中存在的规范性、技术性、真实性方面的问题,并给出相关建议,为促进申请人提高药品注册申报资料质量提供参考。
OBJECTIVE: To summarize the problems existing in the application materials for the change of the drug packaging material and the supplementary application of the expiration date in Guangdong Province. Methods: The problems found in the review were classified, and some of them were discussed. RESULTS AND CONCLUSION: The problems of normative, technical and authenticity existing in the application materials for the change of the drug packaging material and the supplementary application of the expiration date of drugs in Guangdong Province were summarized and relevant suggestions were given, providing reference for the applicant to improve the quality of the application materials of the drug registration declaration .