The national drug alliance procurement office has issued a notification detailing the tendering rules for the 9th national Volume-Based Procurement (VBP) round, along with the finalized drug list. This round involves a total of 42 drugs, spanning 12 treatment areas and representing a market value of RMB 10.963 billion (USD 1.5 billion). Notably, two drugs initially on the shortlist—Baxter’s esmolol and Pfizer’s dexrazoxane—will not participate. All related filings are required to be submitted in Shanghai on November 6, with the tender taking place on the same day.
Manufacturer Standards and Consortium Formation
The rules outline standards for manufacturers, stating that different companies filing the same drug variety under certain conditions will be considered as one filing manufacturer. These conditions include having the same person in charge, a direct controlling or management relationship, confirmation of a subordinate relationship by the China Medical Statistics Annual Report, or a valid registration approval transfer. Enterprises can form a consortium to make a joint filing, with the lowest “unit comparable price” determining the valid filing in cases of multiple consortia.
Bid-Winning Requirements and Pricing
To secure a tender spot, bids must meet specific requirements, such as offering a unit price ≤ 1.8 times the lowest unit price of the same variety, a unit bid price ≤ 0.1 yuan, or a bid price representing a ≥ 50% cut from the ceiling price. Bids will be ranked according to the ratio of the highest price to the lowest price, with certain conditions disqualifying the highest bid prices from winning.
Winning Volumes and Second Backup Supply
The winning volumes are determined based on the number of winning enterprises, ranging from 50% to 80% of the agreed procurement volumes. Specific drugs, such as azithromycin oral liquid and dexamethasone sodium phosphate injection, will have their winning volumes reduced by 10% from the standard. For certain critical drugs, if more than three enterprises win tender spots, a second backup enterprise will be selected by provincial medical insurance departments to ensure supply continuity.
Procurement Cycle
The 9th VBP bidding results will be implemented until December 31, 2027, with agreements to be re-signed annually. This long-term procurement cycle aims to provide stability and predictability for both suppliers and the healthcare system.-Fineline Info & Tech
