The China State Drug Administration held a meeting to request drug regulatory departments at all levels to strengthen the quality and safety supervision of antigen test agents.
According to the official website of the China State Drug Administration, on Tuesday (December 13), the State Drug Administration held a video scheduling meeting to strengthen the quality and safety supervision of the coronary virus antigen test agent, and fully guarantee the coronary antigen test agentQuality and Safety.
The meeting requested that the registers of the crowning antigen detection reagents, as the first responsible person in product quality and safety, must strictly implement the requirements for production quality management specifications.The production address shall not be released from unqualified products to leave the factory and listing, and must not modify the product label and instructions at will.
The meeting requires that the operating enterprise must strictly implement the requirements of the management of the quality management of the operation.It is not allowed to purchase products from illegal channels, shall not change the operating venues and the address of the warehouse without authorization, shall not transport or store products in violation of regulations, or carry out online sales activities in violation of laws and regulations; third -party platforms for online transaction services shall not provide online trading platform services illegally illegally.
The meeting requested that the drug regulatory authorities at all levels found that there were illegal acts and could not guarantee the safety and effective product, and it was necessary to order enterprises to immediately suspend production and recall issues and perform effective disposal.Medical equipment production licenses and punish relevant responsible persons according to law.
The meeting requested that the quality supervision and random inspection of the crown disease antigen test reagent was continued to carry out full coverage of the crown test agent produced by the registered and trusted production enterprises in the jurisdiction.For unqualified products in supervision and random inspections, disposal measures should be taken immediately, and enterprises are ordered to suspend production, analyze and find reasons, and carry out rectifications. Without the re -examination of the provincial drug regulatory department, they must not resume production.
The meeting requires that problems and clues found in the work and clues found in supervision, inspection and random inspection, complaint reports, network monitoring, and risk conferences should be tapped into details and checked in the end.For various types of illegal acts, it is necessary to strictly investigate and deal with it in accordance with the law.Those who are suspected of crime shall be transferred to the public security organs in time.If regulators and other public officials are suspected of malfeasance, they must transfer the disciplinary inspection and supervision organs in a timely manner.
The "new 10 of the epidemic" released by China's official on December 7 mentioned that the scope and frequency of nucleic acid detection was reduced, and antigen detection was encouraged.
