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On March 16, after review by the State Food and Drug Administration, two new coronavirus antigen detection reagent products were approved
.
As of press time, the State Food and Drug Administration has approved 12 new coronavirus antigen detection reagent products
16.
8 dropped to 9.
8, a drop of over 40%
8 dropped to 9.
8, a drop of over 40%
On March 15, the Guangdong Provincial Drug Trading Center issued the "Notice on Adjusting the Prices of the Selected Varieties of the New Coronavirus (2019-nCoV) Testing Reagent Alliance Regional Group's Procurement with Volume"
.
It should be noted that the selected company, Guangzhou Wanfu Biotechnology Co.
The notice pointed out that according to the work arrangement, the relevant products have been adjusted according to the application price of the selected enterprises
.
According to the observation of Cyberblue Instruments, the selected plan for this adjustment is the announcement of the new coronavirus (2019-nCoV) detection reagent alliance regional group procurement selection information on May 21, 2021 by the Guangdong Provincial Drug Trading Center.
The province with the same speed is Henan
.
Industry insiders pointed out to Cyberlane Equipment: the word "active application" in this notice is a precedent for the industry.
Although other consumables procurement has also done this kind of action in the past, the company's quick action this time has a negative impact on production capacity and supply.
A big challenge
.
On the evening of March 15, the National Health and Medical Commission issued the "Notice on Printing and Distributing the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Version 9)", which pointed out that on the basis of nucleic acid detection, antigen detection should be added as a supplement to further improve the ability of early detection of cases.
.
It can be seen that antigen reagents are officially included in the "New Coronary Pneumonia Diagnosis and Treatment Program"
Low price linkage, the highest effective declared price drop ≥50%
Low price linkage, the highest effective declared price drop ≥50% After the national top-level design was announced, many provinces continued to follow up, and the relevant plans for centralized procurement were also officially released
.
On March 16, the Pharmaceutical Procurement Center of Inner Mongolia Autonomous Region issued the "Notice on Launching the Work of Centralized Networking of Novel Coronavirus Antigen Detection Reagents".
From March 16th to March 25th at 17:00, it will be online
.
On March 15, the Shandong Provincial Public Resource Trading Center issued the "Lu-Jin Alliance New Coronavirus Antigen Detection Reagent Special Centralized Procurement Notice", Shandong Province and Shanxi Province formed an alliance (referred to as the Lu-Jin Alliance) to carry out the new coronavirus antigen detection reagent product special project Centralized procurement work
.
The main body of procurement is: medical institutions that meet the requirements of the new coronavirus antigen test
The notice pointed out that the product purchased this time is a novel coronavirus (2019-nCOV) antigen detection kit, and the detection method is not distinguished
.
With the approval of the State Food and Drug Administration, manufacturing companies that have obtained the legal qualifications for the procurement of relevant reagent products can apply for participation
It should be noted that, in principle, the procurement cycle is 1 year
.
During this period, if the selected company purchases in other provinces to generate a new lower selected price, the selected company should apply to the Provincial Public Resources Trading Center within 20 working days for the low linkage
Quotation requirements: Independent quotation according to the price of 1 person of the registration certificate product, which should include all fees such as taxes, delivery fees,
etc.
The quotation is reported in RMB, the unit is "yuan", and it is reserved to 2 decimal places
Enterprises can make their own quotations according to the price of 1 person of registration certificate products, and the quotation shall not be higher than the highest valid quotation price
.
The selected enterprises are determined according to the order of the declared price from low to high, and must meet one of the following conditions:
The quoted price shall not be higher than 1.
3 times of the lowest quotation;
The declared price is ≥50% lower than the highest valid declared price
.
The quotation of the enterprise shall not be lower than the cost
.
If the number of companies to be selected exceeds the number specified in the bidding rules due to the same quotation, the company with the largest committed supply (single-day supply) will be given priority
.
If the supply is also the same, the company with the same quotation will re-quote, and the one with the lower price will be selected
.
The results of the selection will be listed on the centralized procurement platform for pharmaceutical equipment in the alliance provinces, and medical institutions will trade online with the selected enterprises through the procurement platform at the selected price
.
During the procurement cycle, the new crown antigen detection reagents newly produced by the selected enterprises can be applied for online purchase by the enterprises with reference to the prices of the selected products.
The enterprises not selected in this centralized procurement will not be included in the online purchase scope
.
in terms of supply and distribution
.
The selected enterprise is the first responsible person for the production, supply and distribution of reagents.
The selected enterprise can directly supply to medical institutions, or entrust a qualified distribution enterprise to undertake the task of supply and distribution, and be responsible for the distribution and violations of the distribution enterprise
.
The selected companies must ensure that the distribution of reagents covers all medical institutions in the alliance provinces, and that they are supplied in a timely, sufficient and quality manner
.
The selected company and the distribution company entrusted by the selected company must supply at the selected price, and no additional fees such as delivery fees shall be charged
.
The above notice pointed out that the medical institution is the first responsible person for payment settlement, and should settle the payment with the supplier in a timely manner, and the payment time should not exceed 60 days
.
12, accelerated approval by the State Food and Drug Administration
12, accelerated approval by the State Food and Drug Administration From March 11th to 13th, the Medical Device Technology Review Center of the State Drug Administration completed the emergency review of 10 new crown antigen detection products, and completed the emergency review of 2 new crown antigen detection products on March 15, and obtained the Approved by the State Food and Drug Administration
.
Up to now, the Device Review Center has completed the emergency review of 122 products, including 81 new coronavirus detection kits (37 nucleic acid detection reagents, 32 antibody detection reagents, 12 antigen detection reagents), 34 supporting instruments Emergency review of equipment, 4 software, and 3 dressing products, all of which have been approved and marketed by the State Food and Drug Administration
.
According to the official website of the State Food and Drug Administration, it will continue to do a good job in ensuring the quality and supply of new coronavirus vaccines, and accelerate the approval and marketing of new coronavirus treatment drugs and personal self-testing products of new coronavirus antigen detection reagents
.
On March 15th, according to Xinhua Daily, the first batch of retail COVID-19 antigen kits in Jiangsu Province were put on sale in the Yunmicheng pharmacy of Nanjing Pharmaceutical’s subsidiary Baixin Pharmacy at 4 p.
m.
on the 15th.
From the afternoon of January 17, all retail pharmacies under Nanjing Pharmaceuticals can meet the purchasing needs of citizens
.
Since then, the two-wheel mode of centralized procurement of medical institutions + retail of pharmacies has been launched, and another new mode has officially begun
.