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China’s top medical authority requires ‘strictest supervision’ on coronavirus testing reagents

2022/6/9 10:12:40   source:Global Times

China's National Medical Products Administration issued a notice on Tuesday, requiring regulatory authorities at all levels to exercise the "strictest supervision" on the quality and safety of coronavirus testing reagents.

The registrants of the coronavirus testing reagent are required to be responsible for the quality management, including the safety and effectiveness of the product throughout the whole process of development, production, operation and use, said the notice.

Three private virus testing facilities in Beijing have been investigated and punished for violations during the current outbreak of COVID-19, with some of their licenses being revoked by the local regulator, media reported earlier.

Local health officials said that the incident has reflected loopholes and weaknesses in the supervision and management of nucleic acid testing, while vowing to rectify nucleic acid testing institutes in the capital.

As Beijing is counting on nucleic acid testing to fight against the Omicron variant without a lockdown of the city, local authorities have enhanced supervision and management of the testing institutes.

The newly released notice has made more detailed provisions on the production standards, business qualifications and product quality supervision of coronavirus testing reagents, and any violation of laws and regulations will be punished in accordance with the law.

Illegal activities including unauthorized production and operation, illegal storage and transportation and use of unregistered or expired coronavirus testing reagents will be investigated strictly and promptly. Those found guilty of committing a crime will be held criminally responsible in accordance with the law.

Experts said that as the country is launching a normal testing mechanism, private testing facilities still needed to meet the large demand for nucleic acid testing and it is urgent to strengthen the management of these facilities.

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