| 薛晶,王钢力,陈亚飞.新旧化妆品检验规范的对比及对化妆品审评的影响[J].中国药事,2020,34(5):579-584 |
| 新旧化妆品检验规范的对比及对化妆品审评的影响 |
| Comparison of New and Old Cosmetic Inspection Specifications and Their Effect on the Cosmetic Evaluation |
| 投稿时间：2019-12-24 |
| DOI：10.16153/j.1002-7777.2020.05.013 |
| 中文关键词: 化妆品 注册 备案 检验 规范 |
| 英文关键词: cosmetics registration record-filing inspection specifications |
| 基金项目: |
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| 摘要点击次数: 1039 |
| 全文下载次数: 158 |
| 中文摘要: |
| 目的： 全面解读2019年9月10日国家药品监督管理局发布的《化妆品注册和备案检验工作规范》，为开展化妆品审评提供参考。方法： 从多个方面对比已实施的《化妆品注册和备案检验工作规范》和同步废止的《化妆品行政许可检验规范》，分析二者的不同之处对化妆品审评可能带来的影响，并对今后的工作方向提出预见和建议。结果： 《化妆品注册和备案检验工作规范》取消了现行的由药品监管部门对化妆品注册和备案检验检测机构进行资格认定和指定，允许社会优质资源承担化妆品注册和备案检验工作，并对检验工作流程进行了优化，对检验项目要求进行了调整和规范。结论： 《化妆品注册和备案检验工作规范》的发布和实施，对化妆品注册和备案检验以及化妆品审评工作都提出了新的要求，相关部门应尽快适应。 |
| 英文摘要: |
| Objective: To comprehensively interpert the Specifications on the Work of Cosmetics Registration and Record-filing Inspection issued by National Medical Products Administration on September 10th in 2019, and provide a reference for the cosmetic evaluation. Methods: The implemented Specifications on the Work of Cosmetics Registration and Record-filing Inspection and the abolished Cosmetics Administrative License Inspection Regulations were compared from multiple aspects, and the possible impact of the differences between the two inspection specifications on the cosmetic evaluation was analyzed. Some predictions and suggestions for the future were provided. Results: The Specifications on the Work of Cosmetics Registration and Record-filing Inspection cancelled the current qualification and designation of cosmetic registration, filing inspection and testing institutions by drug regulatory authorities, allowing high-quality social resources to undertake cosmetic registration and filing inspections. The inspection workflow has been optimized, and the requirements of inspection items have been adjusted and standardized. Conclusion: The issuance and implementation of the Specifications on the Work of Cosmetics Registration and Record-filing Inspection has put forward new requirements for cosmetic registration and filing inspection as well as cosmetics review, and relevant departments should adapt as soon as possible. |
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