Recently, the 11th batch of national centralized procurement of drugs has been launched, and it has been preliminarily determined that 55 types of drugs will be procured. The person in charge of the relevant department of the National Medical Insurance Administration introduced that this centralized procurement is about to enter the stage of medical institution reporting. The procurement rules will generally adhere to the principles of "stabilizing clinical practice, ensuring quality, preventing bid rigging, and combating internal competition", continuously optimize the selection rules, improve the centralized procurement mechanism, ensure drug supply and reasonable prices, and enable patients to use "high-quality and affordable" drugs, promoting the healthy development of the pharmaceutical industry. The principle of "no centralized procurement of new drugs, centralized procurement of non new drugs" has been adhered to by the national drug centralized procurement for many years. Since 2018, the country has successfully carried out 10 batches of centralized drug procurement, covering 435 types of drugs. The eleventh batch of centralized procurement will continue to focus on "old drugs" that have been on the market for many years and have been clinically used maturely, paying more attention to the multi-level and diversified medication needs of the masses. The person in charge of the relevant department of the National Medical Insurance Administration said that this centralized procurement is linked to the negotiation of the medical insurance catalog. For the first time, varieties that have entered the medical insurance through negotiation and are still within the agreement period have been excluded in the selection of varieties, aiming to protect the innovation enthusiasm of the industry. In terms of variety selection, the deadline for this round of centralized procurement is March 31st of this year, with a total of 7 enterprises using the "reference formulation and quality and efficacy consistency evaluation" from the tenth batch of centralized procurement as the threshold, and further optimizing the screening conditions. As of March 31 this year, a total of 122 drugs have met the preliminary selection criteria, "said Zheng Yi, director of the National Organization for Drug Joint Procurement Office. These drugs also need to meet the" fine screening "conditions of" 7 or more "competition after medical insurance and self funded grouping, and a procurement amount of more than 100 million yuan in 2024. After soliciting opinions from relevant departments, clinical medicine, and pharmaceutical experts, 55 varieties were finally determined to be included in the 11th batch of centralized procurement reporting. Quality is the lifeline of drugs. In response to some patients' concerns about the clinical efficacy and quality of generic drugs, the eleventh batch of centralized procurement has put forward stricter quality requirements: participating companies must have more than 2 years of experience in the production of similar preparations, and the production line of the bidding drugs must not violate the drug production quality management standards within 2 years. At the same time, the medical insurance department stated that it will continue to expand the scope of real-world research, work with the health department to support high-level hospitals in conducting real-world research on the clinical efficacy of selected drugs through centralized procurement, encourage comprehensive clinical evaluation of drugs, and make medication more reassuring for the public. In response to concerns within the industry about excessive "internal competition," this centralized procurement has also imposed clear restrictions on companies offering excessively low prices. Shi Zihai, Deputy Director of the National Healthcare Security Administration, stated that the medical insurance department should optimize specific rules. In terms of selection rules, the calculation anchor point for price differences should be optimized, and the lowest quotation should no longer be used as a reference. At the same time, for the selected enterprise with the lowest quotation, the rationality of the quotation should be publicly explained, and it should be promised that the quotation will not be lower than the cost quotation. In terms of quality assurance, it is required that the production line of the bidding drugs does not violate the drug production quality management standards within 2 years, and the drug regulatory department achieves full coverage of inspection and product sampling for the selected enterprises in centralized procurement. The reporting and volume based procurement of centralized procurement have always been the focus of attention for medical institutions. In the past, centralized procurement was reported based on the generic name of the drug, making it impossible to select specific brands, which to some extent affected the diversified medication needs of medical institutions and patients. This centralized procurement will make optimization adjustments in the reporting and carrying rules, with greater respect for clinical drug selection. The person in charge of the relevant department of the National Healthcare Security Administration introduced that the adjustment of the centralized procurement rules allows medical institutions to choose to report the quantity according to specific brands, including what brands they recognize and how much they expect to use. If the brand is selected, its manufacturing enterprise can directly become the supplier of the medical institution. The purpose of this move is to better match the needs of medical institutions with the selected results. In terms of reasonably determining the agreed procurement quantity, the principle of centralized procurement requires that the total reported quantity should not be less than 80% of the actual usage quantity. However, for medical institutions reporting a decrease in clinical demand or unstable demand due to seasonal or epidemic diseases, the reported quantity can be lowered after the medical institution makes an explanation. This year, based on factors such as market competition patterns and the actual number of selected enterprises, 60% to 80% of the reported quantity by medical institutions will be used as the agreed procurement quantity, and the remaining part will still be chosen by medical institutions as their own brand. For special varieties such as antibiotics and key monitored drugs, the proportion of dosage will be appropriately reduced to leave more room for clinical use. Industry insiders stated in an interview with reporters that practice has proven that centralized procurement is an effective way to control inflated prices. The continuous optimization of centralized procurement rules will guide enterprises to shift from "low price competition" to "quality competition+cost control+reasonable profit". Industry chain resources will accelerate towards areas with high R&D barriers and outstanding clinical value, thereby promoting the gradual standardization of industry order and overall improvement of the quality and accessibility of medication for the public. (New Society)