State Food and Drug Administration: bring the selected drugs from centralized purchase into key supervision and carry out full coverage sampling inspection

2021-11-10

According to the official website of the State Food and drug administration, on November 9, the drug supervision department of the State Food and Drug Administration organized a meeting to promote the quality supervision of selected drugs in national centralized procurement, emphasizing that the selected drugs in centralized procurement should be included in the key supervision scope, full coverage sampling inspection should be carried out for the selected drugs, and adverse reaction monitoring and evaluation and risk signal investigation and disposal should be strengthened. Promoting the implementation of centralized drug procurement is a major decision and deployment of the CPC Central Committee and the State Council to deepen medical reform and improve people's livelihood. It is an important guarantee measure to promote the linkage reform of three medical institutions and promote the healthy development of the pharmaceutical industry. The meeting required that the marketing license holders of selected drugs in centralized procurement should strictly implement the main responsibility for drug quality and safety and continue to produce and operate in compliance. We should continue to strengthen production management, strictly implement the drug production quality management specifications, organize production in strict accordance with the approved prescription process, and conduct in-depth investigation and disposal of various potential risks. It is necessary to continuously improve the drug production quality management system, strengthen the production change management, establish and improve the change control system, deeply carry out change research, and strictly implement the change management requirements. It is necessary to strictly check the release, strictly review the production process and quality inspection, and those that do not meet the national drug standards shall not be released to the market. We should implement the responsibility of the whole process, strengthen drug risk prevention and control, strengthen quality management in the storage and transportation process, do a good job in the information traceability of the whole process, and earnestly fulfill the responsibility of product supply guarantee. The meeting stressed that all provincial drug regulatory departments should implement their regulatory responsibilities, bring the centralized procurement of selected drugs into the scope of key supervision, and take effective measures to effectively strengthen supervision. Establish and improve the supervision account, solidly carry out supervision and inspection, and focus on the production, record and data management, change control, etc. according to the approved prescription process. We should carry out full coverage sampling inspection for the selected drugs, and strengthen the monitoring and evaluation of adverse reactions and the investigation and disposal of risk signals. It is necessary to focus on the low-cost and successful varieties, the varieties with significant changes after the successful selection, the varieties with rising prices of raw and auxiliary materials and enterprises with bad records, strengthen the investigation of potential risks and supervise the continuous compliance production. We should make overall use of various regulatory means, fully allocate regulatory resources at all levels, improve the cross departmental cooperation mechanism, form a regulatory joint force, and ensure drug quality and safety. It is necessary to establish a working mechanism of connection and coordination between administrative law enforcement and discipline inspection, supervision and supervision. If clues of violations of law and discipline are found in the work, they shall be transferred to relevant departments for investigation, handling and reporting according to procedures. It is reported that in order to gradually solve the problem of expensive medical treatment, the state has promoted major reforms in the centralized purchase and use of drugs in recent years. In October this year, the medical reform leading group of the State Council issued the implementation opinions on deeply promoting the experience of Sanming City in Fujian Province and deepening the reform of the medical and health system. In terms of the normalized and institutionalized centralized procurement of drug consumables organized by the state, the opinions made it clear that the scope of procurement should be gradually expanded, and strive to purchase more than 300 generic drugs by the end of 2022. At the end of the 14th Five Year Plan period, the number of common names of drugs purchased by each province, state and provincial organizations in a centralized manner should exceed 500. (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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