On the 15th, the National Organization for Drug Joint Procurement Office announced the selection of the 11th batch of centralized procurement varieties. After three stages of screening, 55 varieties were included in the 11th batch of centralized procurement reporting. In addition, for five generic drugs such as Dapagliflozin oral regular release dosage form and Ethanolamine oral regular release dosage form with fewer indications than the original drug, the joint procurement will reduce the reporting requirements and narrow the reporting range to indications that both the generic drug and the original drug have, ensuring rational clinical use of drugs. The person in charge of the Price Procurement Department of the National Healthcare Security Administration stated that the National Healthcare Security Administration guides joint procurement to adhere to the principles of "stabilizing clinical practice, ensuring quality, preventing bid rigging, and combating internal competition", and further optimize procurement rules. Firstly, adhere to centralized procurement of non new drugs and non centralized procurement of new drugs, and scientifically determine the types of procurement. To protect the innovation enthusiasm of the industry and align with the negotiation of the medical insurance catalog, varieties that have entered the medical insurance through negotiation and are still within the agreement period have been excluded. According to the opinions of the intellectual property department, varieties with high risk of patent infringement have been excluded. At the same time, increase market size conditions and include varieties with an annual procurement amount exceeding 100 million yuan on provincial centralized pharmaceutical procurement platforms in the procurement scope. In addition, some drugs have special characteristics and high risks in clinical use and are temporarily not included in the scope of this centralized procurement. Secondly, strengthen quality assessment and supervision to better ensure medication safety. Further increase the qualification threshold for bidding. New requirements have been added for the quality control capabilities of enterprises to prevent quality risks caused by a lack of production experience. Improve the requirements for production quality inspection, expanding the original "bidding drugs" that do not violate drug GMP requirements within 2 years to "bidding drug production lines" that do not violate drug GMP requirements within 2 years. Meanwhile, further strengthen quality supervision. The drug regulatory department will continue to provide full coverage for the inspection of selected enterprises in national centralized procurement and product sampling. Targeted inspections will be conducted on low-priced selected and commissioned drug production, with a focus on changes in raw materials, production processes, and the impact on quality of selected drugs. Thirdly, optimize the reporting and carrying rules to better adapt to diverse medication needs. One is to optimize the reporting method. Medical institutions can choose to report the quantity according to specific brands, including their recognized brands and expected usage. If the drug is selected, it can directly become a supplier for the medical institution. The second is to respect clinical special needs. In principle, medical institutions are required to report a total quantity of not less than 80% of the actual usage for each variety. If there is a decrease in clinical demand or unstable demand due to seasonal or epidemic diseases, the medical institution may provide an explanation and lower the reported quantity; Meanwhile, drugs and consumables used by public hospitals in providing non basic medical insurance services are not included in the scope of centralized procurement reporting and usage monitoring. The third is to reasonably determine the agreed purchase quantity. Based on factors such as the market competition pattern and the actual number of selected enterprises, 60% -80% of the reported quantity of medical institutions will be used as the agreed procurement quantity. Special varieties such as antibiotics and key monitored drugs will also have their volume ratio appropriately reduced, leaving more room for clinical medication selection. Fourth, optimize bidding rules and guide rational competition in the industry. Optimize bidding rules and guide rational competition in response to industry concerns about excessive "internal competition". One is to optimize the price difference control rules. Optimize the calculation of price differences as an anchor point, no longer simply using the lowest quote as a reference. This way, even if some companies quote low prices, it will not affect other companies that quote normally. The second is to implement a 'low price declaration'. For the selected enterprise with the lowest quotation for each variety, Joint Procurement will require it to provide an explanation of the reasonableness of the quotation, promise not to quote below cost, issue relevant statements, and respond to social doubts about the low-priced selection. The third is to strengthen the prevention of encirclement. Explore the introduction of the "leniency for first-time offenders" mechanism, which allows for lenient treatment in accordance with the law and regulations for the first enterprise to provide clues and effective evidence of bid rigging, as well as the first enterprise to admit to participating in bid rigging during the investigation process, in order to break the interest alliance between bid rigging enterprises. (New Society)