Zhongxin Finance, June 7th. On the 7th, the General Department of the State Food and Drug Administration issued the "Notice on Further Strengthening the Quality and Safety Supervision of New Coronavirus Detection Reagents" (hereinafter referred to as the "Notice"), proposing to implement "the most advanced" new coronavirus detection reagents. "Strict supervision", take resolute and powerful measures, strictly implement the main responsibility of enterprises and user units, strictly implement the territorial supervision responsibility of local governments, do not relax, pay attention to various supervision work, resolutely hold the bottom line of quality and safety, and consolidate the hard-won The results of supervision provide a strong guarantee for epidemic prevention and control.
The "Notice" requires that all provincial drug regulatory authorities should further strengthen the guidance on the research and development and registration application of new coronavirus detection reagents, and do a good job in the verification of the registration quality management system of the application for registration of products, and urge registrants to earnestly perform their main responsibilities to ensure product registration. The research and development process is standardized, and the registration and application materials are true, accurate, complete and traceable.
The registrant of the new coronavirus detection reagent must effectively strengthen the quality management of the whole life cycle of the product, and take responsibility for the safety and effectiveness of the product in the whole process of development, production, operation and use according to law.
In addition, the provincial drug regulatory authorities should maintain the frequency of supervision in accordance with the requirements of the previous work, continue to organize professional forces to carry out supervision and inspection of the registrants of the new coronavirus detection reagents and their entrusted production enterprises in their jurisdictions, and supervise the enterprises to strictly abide by the laws, regulations, standards, and experience. Registered product technical requirements organize production to ensure continuous compliance with the quality management system.
It is necessary to focus on checking the source of product raw materials, production process specifications, product quality control, delivery and market release, adverse event monitoring, product quality analysis and evaluation, etc.
If it is found that there are serious violations in production activities and the safety and effectiveness of the products cannot be guaranteed, the enterprise shall be ordered to immediately suspend production, recall the problematic products and deal with them effectively.
If the enterprise violates the rules seriously, the medical device production license shall be revoked in accordance with the law, and the relevant responsible persons shall be punished in accordance with the law.
The "Notice" clarifies that drug regulatory authorities at all levels should continue to strengthen the quality supervision and sampling of new coronavirus detection reagents. For the new coronavirus detection reagent products produced by registrants and entrusted production enterprises within their jurisdiction, according to the special sampling plan organized by the National Bureau, Carry out full coverage sampling work.
For unqualified products under the supervision and sampling inspection, the drug regulatory department shall immediately take corresponding measures, order the enterprise to suspend production, analyze the reasons for unqualified products, and carry out rectification.
Drug regulatory authorities at all levels must conscientiously implement the "four strictest" requirements, and dig deep into the problems and clues found in the work of supervision and inspection, supervision and random inspection, complaints and reports, network monitoring, and risk consultations.
Violations of laws and regulations such as unauthorized production and operation, illegal storage and transportation, and operation and use of unregistered or expired new coronavirus detection reagents shall be investigated and dealt with quickly and severely in accordance with the law.
Those suspected of constituting a crime shall be promptly transferred to the public security organ.
Supervisors suspected of dereliction of duty shall be transferred to the discipline inspection and supervision organ in a timely manner.
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