According to the newly released "Application Plan for Antigen Detection of The New Coronavirus (Trial)", community residents who have self-testing needs can purchase antigen detection reagents for self-testing through retail pharmacies, online sales platforms and other channels.
On March 12, the State Food and Drug Administration issued a notice approving the application change of the self-test application of new crown antigen products in Nanjing Novizan, Beijing Jinwolf, Shenzhen Huada Inyuan, Guangzhou Wanfu Biology and Beijing Huaketai Biology. Since then, 5 new crown antigen self-test products have been officially launched.
At present, manufacturers are accelerating the supply of major pharmacies and online drug sales platforms.
On March 13, The Jiefang Daily Shangguan News reporter learned from the People's Pharmacy that it has reached a cooperation with Guangzhou Wanfu Biology, and the first batch of new crown antigen rapid test products will land in the stores of the People's Pharmacy in 12 provinces and cities such as Shanghai, Hunan, Jiangsu, etc. At present, the products are in the process of distribution and are expected to be sold in the near future.
It is understood that the new coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) purchased by Shanghai People's Pharmacy this time is one of the 5 similar products approved by the State Food and Drug Administration to apply for changes in self-test applications, which are suitable for oropharyngeal swabs and nasopharyngeal swab samples, and the results can be produced in 15 minutes.
The people's pharmacy said that for customers who need to purchase "antigen rapid test products", pharmacies will require them to show their identity cards, guide them to log in to the "with the application" mini program to fill in personal information, and carry out face recognition real-name registration through the special drug supervision system, and may not use paper and other forms of registration.
The reporter learned from Shanghai Fahrenheit Pharmacy that enterprises are communicating with manufacturers and other aspects, such as selling related products, and will strictly follow the relevant regulations and requirements for the whole process of control.
On the evening of March 13, First Pharma announced that it has reached a cooperation with Nanjing Nuoweizan, and the first batch of new crown antigen testing products has been in the logistics and transportation, and is expected to be sold in stores soon.
In addition, there is news that the Yanghetang pharmaceutical chain is also interested in selling new crown antigen testing products, which are expected to be listed in its pharmacies in the near future.
Industry insiders said that once the antigen detection reagent is implemented on a large scale, it will generate a huge demand for consumption and become a consumer-grade medical product, and the market size is very considerable.
Some people in the industry also hold a cautious wait-and-see attitude, believing that from the current situation, the rapid large-scale screening needs of crowd gatherings in public places are more urgent, and considering the impact of factors such as cost, acceptance, storage and use thresholds, the promotion and popularization of home self-testing may take a long time.
It is understood that the new crown antigen self-test products belong to the three types of medical devices and must be strictly controlled. On March 12, the General Department of the State Food and Drug Administration issued the Notice on Doing a Good Job in the Quality and Safety Supervision of Antigen Detection Reagents for the New Coronavirus, emphasizing the strengthening of supervision and inspection of relevant business links.
The Comprehensive Department of the State Food and Drug Administration requires local drug supervision and management departments at all levels to further supervise and inspect the enterprises that deal in the detection of new coronavirus antigen testing reagents, supervise and guide enterprises to purchase new coronavirus antigen testing reagents from medical device registrants and production and operation enterprises with legal qualifications, do a good job in recording the inspection and sales of incoming goods, and equip them with appropriate facilities and equipment to ensure that the transportation and storage conditions of products meet the labeling requirements of labels and instructions.
The Comprehensive Department of the State Food and Drug Administration also requires attention to focusing on whether the new crown virus antigen detection reagent operated by the enterprise has been registered and approved and has qualified certification documents, and whether the product specification indicates the consumer's personal use instructions. For medical device trading enterprises engaged in online sales, it is also necessary to urge them to display medical device business licenses in a conspicuous position on the main page of the website, and display medical device registration certificates and other information on the product page.