Beijing is stepping up its oversight of exports of coronavirus test kits after several European countries complained about the accuracy of some Chinese-made tests.
Chinese exporters of coronavirus tests must now obtain a registration certificate from the National Medical Products Administration (NMPA) in order to be cleared by China’s customs, the NMPA said in a statement late on Tuesday.
Beijing had been encouraging Chinese firms to export test kits and other supplies to help battle the coronavirus pandemic, leading to a surge of companies offering kits to countries desperate to get a handle on the fast-moving and highly contagious disease.
Some Chinese test kit makers had been taking advantage of easier European Union regulations to get their products into the market before they were approved at home.
In March, Lei Chaozi, an official with the Ministry of Education, said China-made testing kits had already been supplied to 11 countries, including the UK, Italy and the Netherlands.
But the accuracy of some Chinese tests marketed overseas without Chinese approval have been questioned by European health authorities.
Spain withdrew a batch of rapid tests manufactured by Chinese diagnostics firm Shenzhen Bioeasy Biotechnology after the product was found to have low sensitivity, which means they were unable to detect infection sufficiently.
Bioeasy said in a statement last week the inaccurate readings could be because samples were not collected and processed correctly. Bioeasy said it failed to adequately communicate with clients on how to use the test.
Separately, a spokeswoman from China’s foreign ministry spokeswoman said last week that Slovak government officials had questioned the reliability of rapid tests purchased from China.
The preliminary conclusion from the Chinese consulate in Slovakia was that the inaccuracies were the result of medical workers using the kit incorrectly, the spokeswoman said.
The Slovak government did not immediately respond to requests for comment.
ANTIGEN TESTS
Bioeasy's rapid tests, as well as the tests questioned by Slovak officials, are antigen tests, a method that targets the virus' protein to detect infection and can deliver results more quickly than the alternative nucleic acid method.
But antigen tests require higher level of virus load and therefore could fail to diagnose people correctly when the samples only contain small amount of virus, Dr. Chen Guangjie, an immunology professor at Shanghai Jiaotong University, told Reuters.
New coronavirus test makers in China are entering the European market during a transition between two regulatory systems.
A stricter rule will come into force in 2022 that will require many infectious disease diagnostic product manufacturers to follow procedures that can take up to a year or more to get a CE mark that indicates approval to be legally sold in European countries.
Current regulations used by several Chinese companies allow manufacturers to obtain CE Mark after submitting a dossier of documents without compulsory verification by authorised third-parties.
Now, China's tightened scrutiny is interrupting test manufacturers' overseas expansion plans.
Xi'an Tianlong Science and Technology, a Chinese firm which received the CE Mark in March and has been in the process of churning out testing reagents that can supply tests for over one million people, told Reuters it now can't meet its export orders.
"Our reagents don't have (NMPA) certificate and cannot be exported," the company's marketing director Feng Zhenzhen said, adding the firm is "actively" applying for Chinese regulator's approval.
Jam Chan, marketing general manager at Osmunda, a service firm that advises Chinese medical product firms on getting overseas approvals, said many recently developed tests in China haven't gone through strict clinical trials, which means the self-declared accuracy rate printed on the products is not properly validated.
"Better not exporting products than offering inaccurate products that can lead to fake results," said Chan. "The quality of products that have been through domestic review before being exported is at least guaranteed to some extent."
Reuters
Wed Apr 01 2020
Former special forces commander Prabowo to take up Indonesian presidency
Indonesia's Prabowo Subianto will take over as president of the world's third-largest democracy after sweeping the country's election with policies like free meals for school children
Who is Prabowo Subianto, incoming president of Indonesia?
A wealthy ex-general with ties to Indonesia's popular outgoing president and its dictatorial past, looks set to be its next leader.
Trump says he would impose tariffs on China if China went into Taiwan
Republican presidential candidate Donald Trump said he would impose additional tariffs on China if China were to "go into Taiwan,"
Iran's supreme leader says Hamas leader's death will not halt 'Axis of Resistance'
The "Axis of Resistance", built up with years of Iranian support, includes Hamas, the Lebanese Hezbollah group, the Houthi movement in Yemen, and various Shi'ite groups in Iraq and Syria.
Putin says Russia willing to seek compromises between Iran and Israel
Russia is ready to help seek compromises between arch-foes Israel and Iran, President Vladimir Putin said on Friday, saying these would be difficult but possible.
What proposals will Russia push at the BRICS summit?
The proposal is also to establish a BRICS reinsurance company to allow uninterrupted shipment of goods and key commodities between members.
Indonesia's free meals plan in the spotlight as Prabowo readies for office
Prabowo calls the programme one of the main drivers of economic growth, eventually set to add an estimated 2.5 million jobs.
Astro AWANI's revamped English news website, AWANI International, launches on Oct 21
Astro AWANI's revamped English platform delivers in-depth global news and expert analysis to keep you informed on key developments.
Israeli strikes kill 33 people in Jabalia refugee camp in Gaza, medics say
Residents of Jabalia said Israeli tanks had reached the heart of the camp after pushing through suburbs and residential districts.
Liam Payne's ex-partner calls for media restraint after 'painful' death
Cheryl Tweedy used her statement to urge the media to remember they had a seven-year-old son, Bear, who could read the reports.
Analysts: Indonesia's strong MoF leadership team to boost investor confidence
Sri Mulyani Indrawati as head of Indonesia's Ministry of Finance is expected to instil confidence among investors.
Biden offers both a carrot and a stick to Israel as his term nears an end
Israel has frequently resisted US advice and has caused political difficulties for the Biden administration.
Putin says BRICS will generate most of global economic growth
Russian President Vladimir Putin will host a summit of the group in the city of Kazan on Oct. 22-24.
ISIS Malaysia's perspective of Budget 2025
An excellent rakyat-centric budget under the overarching principle of a caring and humane economy.
Budget 2025: Record increase in STR, SARA aid initiatives
The government will provide a significant boost to the Sumbangan Tunai Rahmah (STR) and Sumbangan Asas Rahmah (SARA) initiatives next year.
Budget 2025: EPF contributions to be made mandatory for foreign workers – PM Anwar
The government plans to make it compulsory for all non-citizen workers to contribute to the Employees Provident Fund (EPF).
What policies to expect from Indonesia's new President Prabowo
Prabowo will be open to foreign investment, his aide has said, such as by offering investors management of airports and sea ports.
Budget 2025: Govt allocates RM470 mil to empower women's participation in PMKS
The Women's Leadership Apprenticeship Program will be intensified as an effort to produce more female corporate personalities.
Israel sends more troops into north Gaza, deepens raid
Residents of Jabalia in northern Gaza said Israeli tanks had reached the heart of the camp, using heavy air and ground fire.
Indonesia ramps up security ahead of Prabowo's inauguration
Prabowo Subianto will be sworn in as Indonesia's president on Sunday with Vice President-elect, Gibran Rakabuming Raka, also taking office.