The State Food and Drug Administration held a video scheduling meeting to strengthen the quality and safety supervision of new coronavirus antigen detection reagents
On December 13, the State Food and Drug Administration held a video scheduling meeting to strengthen the quality and safety supervision of new coronavirus antigen detection reagents, thoroughly implement the recent requirements of the State Council’s joint prevention and control mechanism on epidemic prevention and control, and strengthen the implementation of the main responsibility of the registrant and the implementation of territorial supervision responsibilities , to ensure the quality and safety of the new coronavirus antigen detection reagents. Xu Jinghe, member of the party group and deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech.
Fosun Diagnostics (Shanghai) Co., Ltd., Nanjing Novizan Medical Technology Co., Ltd., Zhejiang Dongfang Gene Biological Products Co., Ltd., Shenzhen Yahuilong Biotechnology Co., Ltd., Chongqing Zhongyuan Huiji Biotechnology Co., Ltd. The main person in charge reported the company’s implementation of the main responsibility and the strengthening of production quality management and other related situations. Comrades in charge of Jiangsu Province, Fujian Province, and Chongqing Municipal Food and Drug Administration reported on the strengthening of quality and safety supervision in the production and operation of new coronavirus antigen detection reagents.
The meeting pointed out that in the near future, ten new optimization measures for epidemic prevention and control, and new coronavirus antigen detection application plans have been introduced one after another, putting forward new requirements for the quality and safety of new coronavirus antigen detection reagents. Standing up, we deeply understand the special importance of strengthening the quality supervision of antigen detection reagents, and ensure the quality and safety of antigen detection reagents with a more responsible spirit and more solid work.
The meeting requested that the registrants and production and operation enterprises of new coronavirus antigen detection reagents should fully implement the “Regulations on the Supervision and Administration of Medical Devices” and its supporting rules and regulations, adhere to problem orientation, strengthen bottom-line thinking, focus on hidden dangers of quality and safety risks, and benchmark quality management System requirements, comprehensive investigation and management. As the first person responsible for product quality and safety, the registrant must strictly implement the requirements of the production quality management standard, and must not produce without the quality management system, must not change or increase the production address without authorization, must not release unqualified products from the factory and go on the market, and must not modify the product at will label and instructions. Operating enterprises must strictly implement the requirements of operating quality management standards, and must not operate outside the operating quality management system, engage in operating activities without a license or qualification, must not operate or import products that do not meet statutory requirements, must not purchase products from illegal channels, and must not Unauthorized changes in business premises and warehouse addresses, illegal transportation or storage of products, and illegal online sales activities are not allowed; third-party online trading service platforms are not allowed to provide online trading platform services in violation of laws and regulations. All new coronavirus antigen detection reagent registrants, entrusted production enterprises, operating enterprises, and third-party online transaction service platforms must carefully check whether they have fully fulfilled their responsibilities to ensure that responsibilities are in place, systems are in place, risk prevention and control are in place, and quality management is in place. in place.
The meeting emphasized that drug regulatory departments at all levels must conscientiously implement the decisions and deployments of the Party Central Committee and the State Council, always keep in mind that people’s health is the “big man of the country”, adhere to the supremacy of the people and life, be cautious and make persistent efforts to ensure the quality and safety of antigen reagents . It is necessary to strengthen the inspection of the quality management system, and organize professional forces to supervise and inspect the registrants of the new coronavirus antigen detection reagents, their entrusted manufacturers, and third-party online trading service platforms in their jurisdictions. If violations are found and the product cannot be guaranteed to be safe and effective, the company shall be ordered to immediately suspend production, recall the problematic product and deal with it effectively; if the violation is serious, the medical device production license shall be revoked according to law, and the relevant responsible persons shall be punished according to law. It is necessary to continue to strengthen the quality supervision and random inspection of the new coronavirus antigen detection reagents, and carry out full-coverage random inspections of the new coronavirus detection reagents produced by the registrants and entrusted production enterprises in the jurisdiction. For unqualified products in supervision and random inspection, disposal measures shall be taken immediately, and enterprises shall be ordered to suspend production, analyze and find out the reasons, and carry out rectification. Production shall not be resumed without re-inspection and re-inspection by the provincial drug regulatory department. For problems and clues found in supervision and inspection, supervision and random inspection, complaints and reports, network monitoring, risk consultation, etc., it is necessary to dig deep and investigate thoroughly. All kinds of violations of laws and regulations shall be investigated and dealt with strictly, severely and quickly according to the law. Those who are suspected of committing crimes shall be transferred to the public security organs in a timely manner. Supervisors and other public officials who are suspected of dereliction of duty must be transferred to the discipline inspection and supervision organs in a timely manner.
The leaders of the Food and Drug Administration Sub-bureaus of the provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps, the responsible comrades of relevant departments, and the main responsible persons of the new coronavirus antigen detection reagent manufacturers attended the meeting in their respective branch venues. Relevant comrades in charge of relevant departments and directly affiliated units of the State Food and Drug Administration attended the meeting.