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Two "made in Guangdong" COVID-19 antigen test products have been approved for sale and are expected to be sold in brick-and-mortar pharmacies this week

Date:2022-03-15  browse:102

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Southern Daily News (reporter/Peng Lin Chen Xiao) On March 13, the official website of the State Food and Drug Administration showed that the registration application  

 of five new coronavirus antigen test products was approved. Together with the five approved for the first time, 

a total of 10 novel coronavirus antigen test products have been officially launched so far. Of the five products approved for the first time, two are produced by Guangdong companies,

 namely Shenzhen Huada Inyuan (a subsidiary of BGI) and Guangzhou Wanfu Biology.


Recently, the novel coronavirus antigen Detection Application Plan (Trial) was issued, proposing to add antigen detection as a supplement on  

 the basis of nucleic acid detection. Community residents who have the need for self-testing can purchase antigen detection reagents for self-testing through retail pharmacies,

 online sales platforms and other channels.


The relevant person in charge of BGI said that the company has jointly signed a strategic cooperation framework agreement with eight institutions for novel coronavirus antigen test kits,

 covering the cooperation intention of more than 10 million person-level novel coronavirus antigen test kits, which will be sold soon.


In addition, according to Wanfu Biology, the rapid detection of COVID-19 antigen is easy to operate, has no special requirements for operators, does not rely on equipment,

 and can achieve on-site detection, with the fastest result in 15 minutes.


At present, the above two enterprises are seizing the opportunity to expand production capacity and ensure market supply.


The reporter learned that major e-commerce platforms have put on the shelves the sales information of novel coronavirus antigen test products;

 Offline physical pharmacies are also actively stocking up and are expected to sell within this week.


Guangdong is a major province for the development and production of in vitro diagnostic reagents. 

The R&D and production enterprises of COVID-19 antigen detection reagents are mainly located in Guangzhou, Shenzhen, Zhuhai and Zhongshan.


The reporter learned from the provincial Drug Regulatory Bureau that Guangdong is rapidly investigating the research and production of relevant products in the province and strengthening  

 the guidance of research and development registration.


"Guangdong will give key support to COVID-19 antigen test projects with good early-stage research and development foundation and sufficient production capacity,

 actively strive to be included in the emergency and priority approval channel of the National Food and Drug Administration, and accelerate the approval of antigen test reagents in our province."

Provincial drug regulatory bureau responsible person said.



                                                                                                                   Source:  Nanfang Daily Peng Lin and Chen Xiao

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