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On November 1 and 2, the official website of the State Food and Drug Administration successively released an announcement on the revision of drug instructions for a number of injection products, involving astragalus polysaccharides for injection, sodium chloride injection, banlangen injection, liver hydrolyzed peptide injection and other products
.
.
In recent years, with the increasingly strong demand for drug quality improvement, strict requirements for drug quality and supply in centralized procurement, post-market re-evaluation of injection products, consistency evaluation of generic drugs, etc.
, the clinical use of injections has been standardized, and the safety and accessibility
of drugs for the public have been further guaranteed.
Coincidentally, the Jiangxi Provincial Pharmaceutical Procurement Service Platform recently issued the "Announcement on Soliciting Opinions on the Centralized Procurement Documents of the Inter-provincial Alliance of Drugs (Draft for Comments)", which directly refers to unevaluated drugs, especially injection products
.
As early as 2019, the state issued the Notice on Several Policy Measures to Further Deepen the Reform of the Medical and Health System with the Centralized Procurement and Use of Drugs as a Breakthrough, which mentioned the need to build a national drug public procurement market and a multi-party linkage procurement pattern, "for drugs that are not included in the scope of centralized procurement and use of national organizations, all localities can learn from the experience of centralized procurement and use of drugs organized by the state"
.
Under the guidance of this document, the forms of volume procurement are also becoming more and more abundant, not only multi-level volume procurement such as national centralized procurement, provincial collective procurement, and inter-provincial alliance, but also more flexible models
such as special volume procurement.
The collective procurement of unevaluated varieties can also be regarded as the embodiment of
flexible procurement with quantity.
Industry experts pointed out that with the promotion of the consistency evaluation policy of generic drugs and the active layout of domestic pharmaceutical companies, the number of over-evaluated drugs is increasing
.
For enterprises, if they want to increase the quantity of products, it is the last word to enhance their competitiveness! Although all localities have paid attention to the centralized procurement of unevaluated drugs, in the long run, consistency evaluation is still a strategic choice
to seize the main market share.
In fact, there are precedents for the collective procurement of unevaluated drugs, and Jiangxi Province is not the first time to carry out collective procurement
of unevaluated drugs.
As early as November 2019, the People's Government of Jiangxi Province issued the Notice on the Implementation Plan for the Procurement and Use of Drugs in Jiangxi Province, announcing that among the generic drugs corresponding to generic drugs that have never passed the quality and efficacy consistency evaluation, select some drugs with large clinical use, high purchase amount and sufficient competition, and organize the implementation of quantitative procurement
.
The inter-provincial alliance collective procurement initiated by Jiangxi is the third centralized procurement
in Jiangxi Province.
In 2019, the Jiangxi Provincial Drug Procurement Project has carried out procurement of varieties other than national and provincial volume procurement; In the second batch of unevaluated drug procurement, it was carried out from the original single province, and the development was expanded to the form of an alliance, with the participation
of Jiangxi, Guangdong, Henan and Hubei provinces.
This collective procurement has been expanded to 15 provincial alliances, covering a wider range, covering most of the northwest and northeast and other regions
.
Judging from the centralized procurement documents of the alliance of 15 provinces such as Jiangxi, this procurement continues the overall idea of the first and second batches, and there is not much change
.
According to the procurement documents, the procurement catalogue includes 15 varieties such as papaverine, and the procurement cycle is in principle two years
.
The 15 varieties purchased this time are all chemicals with large clinical use and high purchase amount
.
From the perspective of dosage forms, the number of injections is the largest, 11, accounting for more than 70%; From the perspective of therapeutic areas, the number of drugs in the digestive tract and metabolism is the largest, with 5, and the number of other therapeutic areas does not exceed 2.
Among them, lactulose, oxacillin and pancreatic kininogenase also appeared
in the second round of drug procurement catalogue in Jiangxi.
Lactulose has the effect of promoting bowel movements, and is often used clinically to treat chronic or habitual constipation
.
According to data from Intranet, the sales of lactulose oral solution in China's three major terminal markets in 2021 exceeded 1.
8 billion yuan, a year-on-year increase of 23.
08%.
In the ranking of chemical products for the treatment of constipation, lactulose oral solution ranked first
.
More than ten domestic enterprises have the approval for the production of lactulose oral solution, and many companies have submitted marketing applications for the product in the new registration classification, among which the products of Sichuan Defeng Pharmaceutical have been successfully approved for production and regarded as having been evaluated, which is the first in China
.
Injectable oxacillin sodium is a penicillin antibiotic that was included in the first batch of national essential medicines list
as early as 2009.
According to the Minai database query, there are 20 domestic manufacturers of the product, including well-known pharmaceutical companies such as Kelun Pharmaceutical, North China Pharmaceutical, and Sinonuo Pharmaceutical of CSPC Group, and there are no foreign-funded varieties
.
In terms of procurement volume, the rules for collective procurement are the same as those of the previous two batches, and the agreed purchase volume of each variety in the first year is determined according to the following rules:
If one enterprise is selected, 50% of the agreed procurement volume base in the first year shall be the agreed procurement volume in the first year;
2 For the selected one, 75% of the agreed procurement volume base in the first year is the agreed procurement volume in the first year, of which 50% is used as the agreed procurement volume of the enterprise selected at the lowest price, and 25% is used as the agreed purchase volume
of the enterprise with the highest score in the first year.
The weight of economic and technical standards and commercial standards is 6:4, and the products of the 1 enterprise with the lowest quotation and the 1 enterprise with the highest comprehensive evaluation score are to be selected; If the company with the lowest quotation and the highest overall score are the same company, only 1 company
will be selected.
The economic and technical standard score is roughly composed of the following aspects:
Quality index (69 points): mainly product quality level, divided into 6 aspects, such as original research, past evaluation, Europe, America and Japan listing, etc.
, the score is not cumulative, and the highest score shall prevail;
Supply security index (13 points): different points are assigned according to the distribution rate index;
Comprehensive indicators (18 points): including several indicators such as untrustworthy recruitment records, national procurement selection, market share, coverage of medical institutions, and industry rankings, with different
scores.
In addition, the business standard has a full score of 100 points, of which the quotation is reduced by 50 points and the absolute value of the quotation is 50 points
.
It can be seen from the procurement rules that this Jiangxi Alliance procurement not only pays attention to the balance of technology and price, but also pays more attention to the scoring role
of technical targets.
"In the 'double envelope' mode, in addition to the control of product prices, the advantages of their own products, excellent technical indicators and other factors are also particularly important!" Industry insiders pointed out that from the weight of the evaluation indicators, it can be seen that the score of non-price factors such as product quality and supply guarantee is relatively high, which reflects the synchronous requirements
for drug quality and price.
In addition, comprehensive indicators such as market share and industry rankings are more favorable
to large-scale enterprises.
According to the work deployment of the National Medical Security Bureau, the state organizes the centralized procurement
of over-evaluated drugs.
Nowadays, as a supplement to the mainstream volume procurement model, the volume procurement of unrated drugs has also attracted more and more regulatory attention
.
On June 5, 2020, the National Health Commission and other nine ministries and commissions jointly issued the Notice on Issuing Key Points for Correcting Unhealthy Trends in the Field of Pharmaceutical Purchase and Sales and Medical Services in 2020, which clearly proposed to "promote the pilot procurement of non-over-rated drugs and high-value medical consumables in various localities"
.
On February 26, 2020, the Fujian Provincial Medical Insurance Bureau announced the notice of "Fujian Province Drug Centralized Procurement Documents", officially announcing the 14 procurement varieties and corresponding procurement volumes of this centralized procurement, and these 14 varieties are selected among the drugs with large procurement amount, full competition, mature clinical use, and the same generic name has not yet been evaluated consistently, covering essomeprazole, moxifloxacin, leuprolide and other drugs, which are mostly injections.
The procurement cycle lasts for one year
from the formal implementation of centralized volume procurement.
On December 11, 2019, the Hebei Provincial Medical Drug Device Centralized Procurement Center conducted centralized procurement of 15 kinds of hypertension and diabetes outpatient drugs, and the results showed that 13 drugs entered the proposed selection list, some of which were selected
by pharmaceutical companies that had not passed consistency evaluation.
On August 3, 2019, the "Opinions on Strengthening the Centralized Procurement of Drugs and Medical Consumables" issued by the Shandong Provincial Medical Security Bureau also mentioned that the purchased varieties will focus on drugs
that have not passed the quality and efficacy consistency evaluation.
.
.
.
.
.
.
Under the mechanism of consistency evaluation of generic drugs, many provinces and cities have previously clarified that "for more than 3 production enterprises that have passed the consistency evaluation of drugs of the same variety, drugs that have not passed the consistency evaluation will no longer be selected in the centralized procurement of drugs
.
" "A large number of unevaluated drugs have been suspended
.
In December 2021, the state issued the "14th Five-Year Plan for National Drug Safety and Promoting High-quality Development", clarifying the requirements for further implementing the reform of the review and approval system, and continuing to promote the consistency evaluation of
generic chemical drugs.
In fact, taking the Jiangxi Provincial Alliance collective procurement as an example, not only the product quality index accounted for the highest score, but also designed a number of scoring indicators
from different dimensions.
Through consistency evaluation, it means that the quality and efficacy of generic drugs are recognized, and the evaluated drugs are associated with national centralized procurement, which is of great significance to drug licensees, drug manufacturers and clinical and public drugs, and at the same time, it also helps to promote the export
of domestic generic drugs.
On the other hand, with the deepening of the reform of the drug review and approval system, the control of drug quality will become more stringent, and unevaluated generic drugs will face greater restrictions and fiercer competition, and will eventually have to suspend centralized procurement, cancel drug approvals, and even face delisting
.
In this way, accelerating consistency evaluation will still be a necessary choice
for most pharmaceutical companies.
Industry insiders remind that according to policy requirements, the original research drug plus generic drugs that have passed the consistency evaluation, as long as it reaches 3, can be included in the national centralized procurement, and the first one that has passed the evaluation is of great significance to the enterprise and can help it further expand the market; Pharmaceutical companies that have not been evaluated for a large variety of drugs should speed up their efforts and strive to pass the evaluation as soon as possible!
