The seventh batch of national mining, enterprises are about to enter the game
01 The seventh batch of national mining, enterprises will begin to register
On February 17, Shanghai Sunshine Pharmaceutical Procurement Network issued the "Notice on Carrying out the Seventh Batch of Information Filling in Information Related to the Centralized Procurement of Drugs Organized by the State".
From February 18, the Joint Procurement Office will carry out the seventh batch of information on drugs related to the centralized procurement of drugs organized by the state.
The notice clarifies that the report involves a total of 208 drugs including afatinib oral common-release dosage forms (20mg, 30mg, 40mg, 50mg), etc.
On February 17, from the "Huazhao Pharmaceutical Network" inquiry, it was found that Qinghai, Guangdong, Henan, Shandong, Xinjiang Uygur Autonomous Region (including the Xinjiang Production and Construction Corps) and other provinces and cities have issued notices on the seventh batch of state-organized drug centralized procurement related drug information filling work.
Previously, the seventh batch of national procurement related documents have been clear, medical institutions must fill in the relevant drug procurement demand as required, and submit data before 24:00 on February 16. Before 17:00 on February 25, each province needs to complete the review of the relevant drug procurement demand.
According to the regular progress of procurement with quantity, after the procurement demand is reviewed and reported, it will enter the stage of announcement of collection documents, opening of bids, release of the results of the proposed selection, confirmation of the official selection results and landing time.
02 Clarify the requirements and content of participating enterprises
It is worth noting that the relevant enterprises that fall within the scope of this drug report and meet the drug requirements need to do:
Domestic drug manufacturers providing drugs and accompanying services, drug marketing authorization holders, and overseas drug marketing authorization holders are domestic agents.
(The above-mentioned agent refers to a domestic enterprise legal person in China who, in accordance with the provisions of the relevant state departments on the management of domestic agents of overseas drug marketing authorization holders, and who have obtained a mainland drug registration certificate, is designated in accordance with law to perform the obligations of drug marketing license holders stipulated by laws and regulations on their behalf.) ）
In terms of filling in the content, the notice also makes clear requirements:
1. Proof materials of the domestic agent of the production enterprise, the drug marketing authorization holder, and the overseas drug marketing authorization holder (including the enterprise name, unified social credit code, contact person, power of attorney, etc.).
2. Proof materials that meet the requirements of the drug (including drug registration approval, supplementary registration approval, instruction manual, etc.).
3. Production capacity and instructions for self-production of APIs, etc.
03 The collection is still advancing
The seventh batch of collection and collection involved a total of 58 large varieties, of which more than 20 kinds of injections, and about 10 large varieties with a market size of more than 1 billion.
At the same time, the competition for this collection is fierce, and some product evaluation companies have reached more than 10. According to the incomplete statistics of Cypress Blue, a total of 24 generic drugs have been evaluated for omeprazole injection, and more than 10 pharmaceutical companies have also been evaluated by clindamycin phosphate injection.
In addition to the sixth batch of insulin specials belonging to the early collection and exploration of biological drugs, since December 2018, the national collection and collection of chemical drugs has carried out five batches, and 218 varieties have been selected, with the average reduction of the minimum of 50%, the maximum of 59%, and the highest reduction of more than 90%.
Up to now, the rules of the five batches of collection are stable in: national participation, up to 10 enterprises are allowed to be selected, and the procurement cycle of the varieties selected by 4 or more enterprises is 3 years (1 or 2, 1 year; 3, 2 years; 4 and above, 3 years), and 80% of the agreed procurement volume of 4 or more selected (50% of 1 selection, 60% of 2 companies, and 70% of 3 companies).
Satisfying one of the three conditions of 1.8 times the circuit breaker mechanism, a reduction of more than or equal to 50%, and a comparable unit price of less than or equal to 0.1 yuan is still a condition for the enterprise to obtain the qualification to be selected.
Judging from the previous six batches of seven rounds of national procurement, the increase in the participation of foreign enterprises and the stabilization of the decline in varieties have gradually become a major trend.
Guojin Securities analyzed in a research report that the normalization and institutionalization of collection and procurement, and the expansion goal of drug collection and procurement are in line with expectations. The National Standing Committee proposed that by the end of this year, the total number of drugs collected at the national and provincial levels in each province will reach more than 350. At present, the national collection has involved 234 varieties, plus the seventh batch of 58 varieties, the national collection involves a total of 292 varieties. Considering the normalization of national collection and collection twice a year, coupled with the supplement of provincial collection to national collection, the goal of expanding drug collection and collection is in line with expectations.
The progress of the seventh batch of national mining is still advancing, and Cyberblue will continue to pay attention.