| 何英梅,杨平荣.“四品一械”复检相关规定及复检机构管理的探讨[J].中国药事,2017,(2):121-126 |
| “四品一械”复检相关规定及复检机构管理的探讨 |
| On “4-Product & 1-Device” Retesting Regulations and Retesting Institution Management |
| 投稿时间：2016-08-18 |
| DOI：10.16153/j.1002-7777.2017.02.001 |
| 中文关键词: 食品 药品 保健食品 化妆品 医疗器械 复检 复检机构管理 异议复检 |
| 英文关键词: food drug health food cosmetics medical devices retesting retesting institution management objection review |
| 基金项目: |
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| 摘要点击次数: 1145 |
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| 中文摘要: |
| 目的：研究“四品一械”（食品、药品、保健食品、化妆品、医疗器械）复检的相关规定以及复检机构管理存在的问题，探讨解决问题的措施和办法，为监管部门加强复检机构管理以及检验机构依法依规开展“四品一械”复检提供参考。方法：查阅并分析梳理了相关法律法规和部门规章，结合实地调研和访谈，研究我国在“四品一械”复检的相关规定和复检机构管理方面存在的问题，针对问题提出对策及建议。结果与结论：目前，我国在“四品一械”检验结果异议复检方面的相关规定不统一，复检机构管理存在诸多问题。应从法律法规和制度、监管、检验机构和保障机制等4个层面加以解决。 |
| 英文摘要: |
| Objective: To explore measures and methods for existing problems in the related regulations on "4-product & 1-device" (referring to food, drug, health food, cosmetics and medical devices in this paper) retesting and the retesting institution management, so as to provide references for supervision department to strengthen the administration of retesting institution and for the testing institutions to carry out the retesting work in accordance with the laws, regulations and rules.Methods: Through analyzing and summarizing related laws, regulations and administrative rules, in combination with feld investigation and interviews, the problems existing in the current regulations on "4-product & 1-device" retesting and the retesting institution management were studied, and the corresponding countermeasures and suggestions were put forward.Results and Conclusion: At present, the regulations on the objection review of "4-product & 1-device" test results are not unifed in our, country, and the retesting agency management has many problems which should be resolved from the four aspects, namely, laws and regulations, supervision, retesting institution and safeguard mechanism. |
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