On “4-Product & 1-Device” Retesting Regulations and Retesting Institution Management
He Yingmei, Yang Pingrong
Author information+
Gansu Provincial Institute for Drug Control, Lanzhou 730070, China
{{custom_zuoZheDiZhi}}
{{custom_authorNodes}}
{{custom_bio.content}}
{{custom_bio.content}}
{{custom_authorNodes}}
Collapse
History+
Issue Date
2019-02-26
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 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.
He Yingmei, Yang Pingrong.
On “4-Product & 1-Device” Retesting Regulations and Retesting Institution Management[J]. Chinese Pharmaceutical Affairs, 2017, 31(2): 121-126 https://doi.org/10.16153/j.1002-7777.2017.02.001
