July 18, 2025
Source: drugdu
91
On July 15th, the National Organization Drug Joint Procurement Office issued a notice to launch the 11th batch of national organization drug centralized procurement related drug information reporting work. The reporting time for enterprises is from July 16th, 2025 to July 31st, 2025 at 4:00 pm.
According to relevant information, in the initial stage of variety selection, the eleventh batch of centralized procurement will end on March 31, 2025, and the selection criteria will continue to use the "number of reference preparations and generic drug companies that have passed consistency evaluation reaches 7 or more" from the tenth batch of centralized procurement. A total of 122 varieties meet the entry threshold. After three stages of screening, 55 varieties were finally included in the 11th batch of centralized procurement reporting.
The drugs included in the scope of centralized procurement are mainly oral sustained-release forms and injections, accounting for over 80% of the total. Some varieties have fierce competition. As of early June this year, there were over 30 companies eligible to apply for multiple injections, and there were also over 20 companies eligible to apply for multiple injections, oral sustained-release formulations, and other products.
It is worth noting that when the National Organization for Joint Procurement of Drugs released the 55 drugs to be included in the 11th batch of centralized procurement, it also simultaneously released 68 drugs that met the evaluation criteria but were not included in the 11th batch of centralized procurement, and provided specific reasons for their non inclusion.
Zhong Chongming, former associate researcher at the National Medical Insurance Research Institute of Capital Medical University, said that the biggest difference in the 11th batch of centralized procurement compared to before is that the list of those who have passed the evaluation but have not been included in the centralized procurement was also announced. It can be confirmed that for the reform of centralized procurement, a considerable number of varieties will be temporarily exempted from centralized procurement.
The highlight of the 11th batch of centralized procurement is that the varieties included in the centralized procurement are firmly adhered to, including many large manufacturers, varieties, and discussions; the varieties that have reached the number of households but have not been included in the centralized procurement are also firmly adhered to, including large and small manufacturers, varieties, and discussions. The new standards are also resolutely open, fair, and just for everyone. With this as the working spirit, principle, and rule, there will be no harm in the future, and there is courage to be tested, "Zhong Chongming told 21st Century Business Herald reporters.
Two drug catalogs
According to the announcement, the National Joint Procurement Office for Drugs has released two catalogs: "Drugs to be included in the 11th batch of centralized procurement" and "Drugs that have exceeded the evaluation criteria but have not been included in the 11th batch of centralized procurement".
Firstly, focus on the list of drugs to be included in the 11th batch of centralized procurement. According to a report by People's Daily, the head of the National Joint Procurement Office for Drugs pointed out that the selection process for inclusion in this centralized procurement includes three stages. The first stage is to screen based on factors such as the medical insurance catalog and market size; The second stage is to solicit opinions from clinical medicine and pharmaceutical experts; In the third stage, based on the opinions of relevant departments and experts, further eliminate varieties with related risks.
21st Century Business Herald reporters found that the 11th batch of centralized procurement mainly includes oral sustained-release dosage forms and injections, among which there are 23 varieties of oral sustained-release dosage forms, accounting for 41.8%; There are a total of 22 types of injections, accounting for 40.0%. In addition, it also includes dosage forms such as granules, inhalers, oral liquids, and patches.
Multiple varieties, especially injections, are facing significant competition. As of early June this year, there are currently over 30 companies eligible to apply for injections such as cefazolin, famotidine, and dihydroxypropyl theophylline. In addition, the number of injectable drugs such as Metoclopramide and Lenox, oral sustained-release formulations such as Cobaltamide and Dapagliflozin, as well as oral liquid formulations such as formoterol inhaler and desloratadine, has reached or exceeded 20.
According to data from MineNet, Loxoprofen Patch/Loxoprofen Patch, Cefotaxime, Famotidine and other injections, as well as oral sustained-release forms such as Pravastatin, Dapagliflozin, Olaparib, etc., are all large varieties worth over 1 billion yuan.
Among them, cefazolin injection appeared for the first time on the centralized procurement list, and the sales scale of this variety in public medical institutions in China was 4.2 billion yuan in 2024. In addition, Loxoprofen Patch/Loxoprofen Patch is the first chemical patch to be included in the national procurement. In recent years, the sales of this drug in public medical institutions in China have been growing at a double-digit rate, approaching 1.5 billion yuan in 2024, a year-on-year increase of 10.92%.
Sorting out another list of drugs that have passed the evaluation criteria but were not included in the 11th batch of centralized procurement, it was found that there are a total of 68 varieties in the list, including injections, oral sustained-release formulations, inhalers, oral liquids, eye drops, and other formulations.
In terms of specific reasons, they include "distinguishing the nature of medical insurance through 'cross medical insurance catalog' varieties, and all product specifications do not meet the full competition pattern", "the procurement amount in 2024 according to the statistics of provincial pharmaceutical centralized procurement platforms is less than 100 million yuan", "consistency evaluation has not been initiated, and there are new and old batches at the same time", "high risk of patent infringement", "high risk of clinical use, adopting departmental and expert opinions", and so on.
The person in charge of the Price Procurement Department of the National Medical Insurance Administration stated that this centralized procurement protects the innovation enthusiasm of the industry, excludes varieties that have entered the medical insurance through negotiations and are still within the agreement period, and also excludes varieties with high patent infringement risks. The market size conditions have been increased, and varieties with an annual procurement amount exceeding 100 million yuan on provincial pharmaceutical centralized procurement platforms have been included in the procurement scope. In addition, based on the clinical usage characteristics, some key managed antibiotics and drugs with frequent adverse reactions are temporarily not included in the scope of this centralized procurement, taking into account the opinions of relevant departments and experts.
Zhong Chongming stated that the number of evaluated products that meet the criteria but have not been included in the centralized procurement list will be announced, and the confirmation of centralized procurement varieties will be brought from the original industry recognition to the new recognition standards. This clearly brings some opportunities that are in line with the trend of refinement in the centralized procurement reform, but there are also some issues that need attention.
For example, will these standards be applicable in the long term in the future? Correspondingly, when may the relevant products be included in centralized procurement? For example, do all these standards equally reflect fairness and efficiency? For example, to what extent will these products included in the centralized procurement this year face reasonable competition?
Continuously deepening reforms
Through these two lists, it can be found that the centralized procurement reform is to break the seemingly 'one size fits all' procedural importance and see through the rationality and irrationality under this so-called procedural importance, "said Zhong Chongming.
Zhong Chongming further pointed out, "We need to focus not only on simplification or refinement, but also on fairness, efficiency, quality, and so on. Overall, the new centralized procurement standards include two aspects: one is the standards for not entering centralized procurement, and the other is the standards for the outcome of already entering centralized procurement. These two aspects should not be divergent, because centralized procurement and its surrounding areas will be the general environment for normalized governance in the future
In the face of the situation where the number of evaluators meets the conditions but not all of them are included in the centralized procurement, given the main tone of comprehensively promoting drug price governance, it is more urgent to effectively utilize online governance and incorporate the essence of centralized procurement such as the "National List" and "Differential Price Comparison" into regular monitoring and management.
Zhong Chongming stated that in the eleventh batch of centralized procurement and beyond, centralized procurement may clearly return to the local key governance of the relationship between quantity and price, while widely supporting the systematic and moderate development of the relationship between price and quality in the pharmaceutical industry. This balances meeting historical needs with current conditions. It is difficult for the medical insurance department to fully implement strategic purchases represented by centralized procurement within a limited period of time, as this project combines the complexity of industry, clinical, economic, social, and cultural aspects. Grasping the main problems and contradictions, maintaining fairness and efficiency, or even more worthy of expectation.
Which varieties and specifications are included in centralized procurement? This is a synchronous statistical method based on the large market, using sales data, drug regulatory batch number data, intellectual property disputes, and other factors to classify them.
Transitioning from a few zoning standards to more zoning standards requires reform courage. In theory, it is becoming increasingly difficult to move from shallow water areas to deep water areas. It is expected that the reform of centralized procurement by the medical insurance department will focus on both centralized and non centralized procurement (network management). Therefore, it is necessary to align the two paths of centralized procurement and non centralized procurement (network management) as soon as possible through a series of efficient monitoring and effective management, "said Zhong Chongming.
For example, centralized procurement depends on quality standards, while penetrating through centralized procurement and non centralized procurement (online governance) may penetrate through quality standards to consider rationality and irrationality; For example, refinement is a high difficulty task in the reform of centralized procurement, and the medical insurance department may need to penetrate both inside and outside the 11th batch of centralized procurement to address seemingly similar price governance issues, as specific products may be in different states of alleviation, difficulty, or evolution within and outside the centralized procurement.
For example, is it possible to penetrate the surface of the centralized procurement procedure and see through the urgency and importance of the actual need for centralized procurement of related products inside and outside the eleventh batch of centralized procurement? Assuming that non centralized procurement (online governance) will be the main focus in the future, supplemented by centralized procurement, it is necessary to clarify the similarities and differences between centralized procurement and non centralized procurement, transcend the surface of the procedure, and work together towards a unified large market and high-quality development.
In addition, after the eleventh batch of national procurement, it is also necessary to pay attention to some changes. Zhong Chongming stated that the first priority is to pay attention to how provincial alliance procurement will be promoted. In the face of this problem, we need to identify the essence and significance of centralized procurement, not how rough or delicate the procedures are, but the price issue that needs to be solved or alleviated through centralized procurement or similar management procedures.
After the 11th batch of national procurement, we also need to pay attention to the impact of local drug price inflation on the budget plate of innovative drugs and other participating countries. The variety of centralized procurement is less than expected, and people are paying more attention to centralized procurement and surrounding areas, stabilizing the development of pharmaceutical output value. The national procurement has entered the 'dual catalog' (basic medical insurance catalog and commercial insurance innovative drug catalog) to expand financing, which is worth looking forward to. In addition, deepening the medical reform 'changing cages for birds' to a certain stage, adding one cage to commercial insurance, releasing several birds in centralized procurement, and effectively managing the medical insurance fund and patient burden through efficient payment, compiling many clues and opportunities into a big proposition, which is also worth looking forward to, "said Zhong Chongming.
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