Zhongxin Finance, February 11. On the 11th, Li Maozhong, head of the Drug Administration Department of the State Drug Administration, said at the State Council's policy briefing on the progress of deepening the reform of centralized procurement of drugs and high-value medical consumables. According to the results of random inspection and adverse reaction monitoring, no abnormal quality has been found in the varieties selected by the national centralized procurement.
According to Li Maozhong, the State Food and Drug Administration has always regarded the quality supervision of the selected products in centralized procurement as the top priority of drug supervision, taking multiple measures to strengthen quality supervision, and fully implement the work deployment of the State Council on the normalization and institutionalization of centralized procurement work. , serve the reform of "three medical linkages".
In terms of strengthening the quality supervision of selected drugs in centralized procurement: firstly, a work plan was issued, and a full-coverage supervision and inspection of selected enterprises in centralized procurement was deployed, and a full-coverage sampling inspection of selected products was carried out, and the selected enterprises were supervised strictly in accordance with the approved drug standards and production process organization. Production, strictly abide by the quality management standards for drug production, and urge the implementation of the main responsibility of the enterprise and the responsibility of territorial supervision.
The second is to establish a drug variety file information system to share basic information such as drug production process and quality standards with the provincial drug supervision and management departments to further improve the pertinence of supervision and inspection.
The third is to steadily promote the traceability management of selected drugs from centralized procurement, and gradually realize the traceability of the whole process after the drugs selected from centralized procurement are listed.
The fourth is to issue the management measures for post-marketing changes and related technical guidelines to standardize the management of post-marketing changes.
The fifth is to strictly implement the "four strictest" requirements, and urge enterprises to make timely rectification of defects found in the supervision and inspection;
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