四品一械复检相关规定及复检机构管理的探讨.PDFVIP

中国药事 2017 年 2 月 第 31 卷 第 2 期 121 ·监督管理· “四品一械”复检相关规定及复检机构管理的探讨 何英梅，杨平荣 *（甘肃省药品检验研究院，兰州 730070） 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。 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 中图分类号：R955 文献标识码：A 文章编号：1002-7777(2017)02-0121-06 doi:10.16153/j.1002-7777.2017.02.001 On 4-Product 1-Device Retesting Regulations and Retesting Institution Management He Yingmei, Yang Pingrong* (Gansu Provincial Institute for Drug Control, Lanzhou 730070, China) Abstract 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 field 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 unified 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 insti