Notice of the General Department of the State Administration of Drug Administration on cracking down on the illegal production and sale of COVID-19 virus detection reagents
Drug Administration Comprehensive Machinery Management Letter [2020] No. 203
Provinces, Autonomous Regions, and Municipalities Drug Administration, Xinjiang Production and Construction Corps Drug Administration:
Since the outbreak of the COVID-19 epidemic, the State Drug Administration has approved the registration of 22 testing reagent products, continuously meeting the needs for epidemic prevention and control. Recently, it has been discovered that some unregistered related testing reagent products are falsely publicized, which seriously disrupts market order. In order to effectively purify the market environment and effectively protect public health rights and interests, the relevant requirements for severely cracking down on the illegal production and sale of COVID-19 virus detection reagents and other medical devices are notified as follows:
I. Drug supervision and management departments at all levels shall effectively implement the “four most stringent” requirements for drug safety, and follow the “Notice of the Comprehensive Department of the State Administration of Drug Administration on Effectively Doing a Good Job in the Quality Supervision of Medical Devices for the Prevention and Control of Pneumonia Caused by New Coronavirus Infection” (Pharmaceutical Comprehensive Power [2020] No. 2) and other documents were deployed to increase supervision and inspection of relevant diagnostic reagent production and operation companies, third-party platforms for medical device network trading services, and online sales companies. For clues about violations of laws and regulations, drug supervision and management departments at all levels shall promptly organize investigations and reports to the State Drug Administration.
2. Drug supervision and administration departments at all levels must attach great importance to case clues reflected through channels such as network monitoring, complaint reporting, public opinion monitoring, supervision and inspection, and departmental notification, and dig deep for detailed investigation. Those who engage in production or business activities without permission, and those who produce or operate relevant testing reagent products without registration and approval, shall be investigated promptly and severely according to law. If the operator of the third-party platform of the medical device network fails to fulfill the obligations of registration and verification of the e-commerce merchants, and fails to deal with the relevant false information in the platform in a timely manner, it will be advised to make an offer and rectify within a time limit. Those who refuse to rectify or fail to make corrections shall be investigated and dealt with seriously according to law and exposed.
The drug supervision and management departments at all levels must strengthen coordination and cooperation with the public security, online information, and communications authorities. The websites and APPs that release false information and produce and sell illegal COVID-19 virus detection reagents and other products must promptly report to online information. 2. The competent communications department; those suspected of crime shall be promptly transferred to public security organs according to law.
Information about the COVID-19 virus detection reagents approved by the State Drug Administration can be dynamically inquired through the official website of the State Drug Administration (http://www.nmpa.gov.cn/). If any violations are found, please report to 12315.
General Department of State Drug Administration
March 26, 2020