What’s new: As China rolls out more mass Covid-19 testing, the country’s top drug regulator issued tough new rules and a warning for makers of Covid test agents.
Under the new regulations for the development, production and use of test materials, serious violations affecting the safety and effectiveness of the products would result in suspensions for producers and recalls, the National Medical Products Administration said Tuesday.
Suppliers found committing the most serious violations may have their licenses revoked, and those responsible may be punished, according to a notice from the administration.
At least eight test providers were investigated or punished for violations so far this year. Last month, police in Beijing probed three mass testing labs, accusing them of improper testing leading to inaccurate results. Three health officials were also under investigation by the Communist Party’s graft watchdog for alleged involvement in Covid lab testing fraud.
The background: The government ramped up a crackdown on illegal activities involving Covid testing labs and corruption in the health system as country deals with its worst Covid-19 outbreak in two years.
In May, central government officials including Vice Premier Sun Chunlan — who is in charge of implementing and supervising the central government’s Covid response — set a target of having a Covid-19 testing facility within a 15-minute walk for residents in major cities.
Since April, at least seven provincial-level regions and 55 cities that together account for nearly 40% of China’s population launched regular testing plans, according to a May 29 research note from Soochow Securities Co. Ltd.
There are about 13,000 laboratories and 153,000 technicians in China qualified for providing nucleic acid testing, according to data disclosed by the National Health Commission in May. The National Center for Clinical Laboratories carries out monthly laboratory quality evaluations, which have found that 99.4% of labs meet the requirements.
Contact reporter Denise Jia (huijuanjia@caixin.com) and editor Bob Simison (bob.simison@caixin.com)
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