CHINESE JOURNAL OF MEDICINAL GUIDE >

2025 , Vol. 27 >Issue 6: 543 - 547

DOI: https://doi.org/magtech.2025.01.27-00001

Study on the Coordination Mechanism of Drug Quality Control Testing

  • Baobin HUANG ,
  • Wen-Ting LIU
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  • National Institutes for Food and Drug Control， Beijing 102629， China

Received date: 2025-01-27

  Revised date: 2025-05-28

  Accepted date: 2025-08-02

  Online published: 2025-08-06

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Abstract

Objective： In accordance with the "coordinated national planning" work approach for drug supervision， and in line with the requirements for the coordinated work of the central and local drug regulatory agencies， drawing on the international management practices of medicines control laboratories to achieve mutual recognition of test results and sharing of tasks through the unification of technical requirements for testing and information sharing， in order to strengthen coordination of drug quality contral testing in China.Methods： To study the working mechanism of the European network of official medicines control laboratories （OMCL） and the World Health Organization's national control laboratory network for biologicals （NNB）， and their management practices in the batch release of biological products， post-market sampling testing， and the identification and testing of counterfeit and substandard drugs. Combined with the characteristics of the collaboration between national and local drug testing institutions in China， relevant suggestions for strengthening coordination among national and regional drug testing institutions in China are put forward.Results and Conclusion： It is recommended to take measures such as conducting capacity assessment， strengthening information exchange and sharing， and formulating technical guidelines and unifed testing forms to improve the synergy and consistency between national and provincial testing institutions in terms of registration testing， post-market sampling test， import inspection， batch release of biological products， and identification and inspection of counterfeit and substandard medicines， thereby enhancing the joint force of regulatory technical support.


Key words：  ; Drug quality control testing； ; Coordination； ; European network of official medicines control laboratories； ; WHO national control laboratory network for biologicals

Cite this article

Baobin HUANG , Wen-Ting LIU .

Study on the Coordination Mechanism of Drug Quality Control Testing

[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2025 , 27(6) : 543 -547 . DOI: magtech.2025.01.27-00001

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