中国食品药品监管Issue(8)：124-129,6.DOI:10.3969/j.issn.1673-5390.2025.08.014
浅析广东省牙膏简化备案中安全使用历史证明资料的常见问题
Analysis of Common Issues in Safety Use History Documentation for Toothpaste in the Simplified Filing Process in Guangdong Province
摘要
Abstract
Objective:This study aims to analyze common issues in safety use history documentation for toothpaste under the simplified filing process in Guangdong Province,so as to improve filing quality and provide references for both enterprises and regulatory authorities.Methods:Filing data from October 1th to November 30th,2023,were reviewed,and common problems in safety use history documentation were identified.Recommendations for improvement were proposed accordingly.Results & Conclusion:Frequent problems were found in production batch records,inspection reports,sales invoices,and statements of commitment regarding product safety and the authenticity of filing materials.These issues adversely affected the quality and approval rate of toothpaste filings.It is recommended to improve the legal framework,strengthen enterprise accountability,and standardize review criteria to ensure the smooth implementation of toothpaste supervision and management.关键词
牙膏/简化备案/安全使用历史/问题/分析Key words
toothpaste/simplified filing/safety use simplified/common history/analysis分类
化学化工引用本文复制引用
季宸旭,鄢千铧,胡安雪..浅析广东省牙膏简化备案中安全使用历史证明资料的常见问题[J].中国食品药品监管,2025,(8):124-129,6.基金项目
广东省药品监督管理局2025年科技创新项目(S2024TDZ029) （S2024TDZ029）
