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Medical Network News, September 6 On September 3, the official website of the National Health Commission issued the "Notice on Printing and Distributing the Work Regulations of the National Key Monitoring and Reasonable Use of Drugs List" (hereinafter referred to as the "Regulations")
.
The "Regulations" will come into effect on the date of issuance, which may mean that the second edition of the National List of Key Drugs to be Monitored is also about to be released
.
The "Regulations" clarified that the drugs included in the catalogue management should be chemical drugs and biological products that have a lot of unreasonable clinical use, abnormally high usage amounts, and a greater impact on the rationality of medication
.
Key including adjuvant, antineoplastic agents, antimicrobials, proton pump inhibitors, glucocorticoids, parenteral nutrition drugs
.
At least one year of local monitoring is required for drugs to be transferred.
On July 1 , 2019, the National Health Commission and the State Administration of Traditional Chinese Medicine issued the "First Batch of National Key Monitoring Drugs List (Chemical Drugs and Biological Products)", and 20 The use of a variety of drugs is included in the scope of key monitoring
.
On this basis, the provinces have made slight adjustments to it
.
Compared with a total of 20 varieties included in the first batch of catalogs, the number of drug varieties included in catalog management after this adjustment will increase to 30
.
Because the "Regulations" are clear, the number of drug varieties included in the national key monitoring catalogue management is generally 30, and the time for updating and adjusting the catalogue is not less than 3 years in principle
.
Among the drug categories that have been focused on, anti-tumor drugs and proton pump inhibitors are on the list
.
With the increase in the number of cancer patients in China, the reform of the drug regulatory review and approval system has further promoted the development and listing of innovative drugs.
Innovative tumor drugs have become a hot area for pharmaceutical companies to invest heavily
.
Focusing on market segments and clinical needs, truly patient-centered, serious and reasonable use, and benign market competition have attracted the attention of regulatory authorities
.
In this field of treatment, the most importantly monitored should be adjuvant drugs for the treatment of tumor diseases, such as thymopentin, immunosuppressive agents and other types of products.
.
In the category of digestive system chemicals, proton pump inhibitors are used most frequently
.
According to data from Minai.
com, among the top 10 chemical drug sales products, clinically common esomeprazole, lansoprazole, omeprazole, pantoprazole, etc.
are all listed
.
Take Esomeprazole as an example.
In recent years, the terminal sales of the drug in Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) have gradually increased, and the first breakthrough in 2019 5 billion yuan, an increase of 15.
71% year-on-year
.
In 2019, the top 3 terminal esomeprazole manufacturers in China's public medical institutions were AstraZeneca, Chia Tai Tianqing and Chongqing Laimei Pharmaceuticals.
Among them, the original research manufacturer AstraZeneca's market share fell from 98.
66% in 2015 to 2019 While the market share of CP Tianqing has increased year by year, it has exceeded 20% in 2019
.
This time, it has been closely watched by the national key monitoring catalog
.
It remains to be seen which proton pump inhibitors will eventually be included .
The "Regulations" pointed out that the adjustment of the national version of the key monitoring catalog includes four stages: initiation adjustment, local selection and recommendation, expert summary, and announcement of results
.
Among them, in the stage of local selection and recommendation, general hospitals above level 2 can, based on comprehensive factors such as clinical irrational use of drugs, usage amount, clinical value, etc.
, after research and selection by the hospital's Pharmaceutical Management and Pharmacotherapy Committee, they will not distinguish between the dosage form and the drug.
The common names are sorted according to the degree of recommendation from strong to weak, and the information of the top 30 varieties with the strongest recommendation is stamped with the official seal of the hospital and submitted to the provincial health administrative department
.
The provincial health administrative department assigns corresponding scores to the 30 varieties recommended by each hospital.
That is, the first-ranked variety is assigned a value of 30, and the second-ranked variety is assigned a value of 29 points.
The 30th place is assigned 1 point
.
On the basis of the generic name of the drug, the provincial health administrative department sums up the assignments of all the varieties submitted by general hospitals above the level of jurisdiction to obtain the total recommended score for each variety, and then follow the scores from high to low.
Sorting (If the score is the same, it can be sorted side by side and occupy subsequent rankings)
.
The information of the top 30 drugs (including other drugs with a tie score on the 30th) will be stamped with the official seal and submitted to the Medical Administration and Hospital Administration of the National Health Commission
.
It is worth noting that for the drugs adjusted out of the original catalog, the local health administrative department should continue to monitor for at least one year, and grasp their prescription reviews, usage, and usage amount, so as to promote the continuous improvement of the level of clinical rational use of drugs
.
The market for key monitored varieties has shrunk by nearly 80%
.
The restrictions on key monitored varieties do not stop at the national catalogue
.
After the announcement of the first national version of the key-monitored varieties catalogue in 2019, the first batch of key-monitored varieties catalogues of various provinces (cities) have also been announced.
Injections and nutritional injections are the main categories supplemented by the provinces
.
For example, the Hubei Provincial Health Commission released the first batch of key monitored drugs catalogues, adding Guhong injection, Shenxiong injection, Lugua polypeptide injection, placental polypeptide injection, and safflower yellow injection to the national version.
Wait for 5 varieties
.
According to statistics from Minai.
com, 11 of the 20 drugs in the first batch of national key monitoring catalogues are over 1 billion varieties, including thymopentin, ribonucleic acid II, invert glucose electrolyte, edaravone injection, calf serum albumin, Oxiracetam, cerebroside carnosine, troxerutin cerebroprotein hydrolysate, creatine phosphate sodium, complex coenzyme and Danshen ligustrazine
.
At present, the work of clearing and retiring provincial-level supplements in the medical insurance catalog is accelerating.
Judging from the adjustments announced by various provinces and cities, the first to be "cleared" by the medical insurance catalog is the key monitoring drug
.
Without the heavy support of the medical insurance catalogue, from the relevant data, the sales of the first batch of key monitoring products included in the national edition have declined significantly
.
The total sales data of the 20 types of sample hospitals in 2018 was 47.
46 billion yuan.
In 2019, the market size dropped to 37.
85 billion yuan and only 10.
98 billion yuan in 2020.
The market shrank by nearly 80%
.
List of key monitoring drugs for enterprisesThe impact is not only on the level of the medical insurance catalog, but also on the centralized procurement of medicines
.
For example, in Zhoushan, Zhejiang, the key monitored drugs will be transferred out of the procurement catalog list in 2019, involving laoxycephalosporin, enoxaparin sodium, reduced glutathione, ceftriaxone sodium, piperacillin sodium, tazobactam sodium, 10 specifications including Bailing Capsules
.
In August 2019, based on the list of key monitored drugs published by the National Health Commission and Qinghai Provincial Health Commission, Qinghai carried out centralized procurement of key monitored drugs with large purchases and high purchase amounts, and the bid price must not be higher than the current national The lowest provincial purchase price (excluding GPO purchase price) is based on the number of bidding companies to decide whether to purchase by bidding or by bargaining/negotiation
.
Wuhan City chose to purchase 30 key clinically monitored varieties through centralized bargaining, and imposed strict restrictions: there is no quantitative agreement for key monitored varieties, and no advance payment of medical insurance funds; at the same time, a maximum price limit (effective quotation) is set for the company.
0.
7 times of the lowest price of the provincial-level online listing for the variety, if it is higher than the highest limit price, the quotation will be invalid
.
Insiders believe that the price cuts of key nationally monitored drugs are a high probability event, and driven by the current national linkage of drug prices, there should be a situation where price cuts in one place will follow the country
.
On the whole, price reduction of medicines is a mainstream trend.
In the future, most medicines, including key monitoring catalogs, will be exchanged for the market through price cuts
.
The National Key
Controlled Drugs Catalogue Adjustment Work Procedures Article 1 is to strengthen the management of clinical rational use of drugs in China, promote the formulation and adjustment of the national key controlled rational use of drugs catalog (hereinafter referred to as the catalog) to be more scientific and reasonable, continuously standardize clinical drug use behavior, and safeguard the people Health rights, formulate this regulation
.
Article 2 The drugs included in the catalogue management should be chemical drugs and biological products that have a lot of unreasonable clinical use, abnormally high amounts of use, and have a greater impact on the rationality of drug use
.
The focus includes adjuvant drugs, anti-tumor drugs, antimicrobial drugs, proton pump inhibitors, glucocorticoids, parenteral nutrition drugs, etc.
.
Article 3 The adjustment of the catalogue adheres to the principle of "openness and transparency, local recommendation, and dynamic adjustment", and aims to standardize clinical drug use and promote rational drug use
.
Article 4 In principle, the time for updating and adjusting the catalog is not less than 3 years, and the number of drug varieties included in catalog management is generally 30
.
Article 5 The National Pharmaceutical Administration and Therapeutics Committee (hereinafter referred to as the National Pharmaceutical Council) provides professional technical support for the scientific adjustment catalog, and undertakes the collection, sorting and analysis of recommended materials from various regions
.
Article 6 The adjustment of the catalogue includes four stages: initiation adjustment, local selection and recommendation, expert summary, and results announcement
.
(1) Start adjustment
.
National health committee released the directory adjustment notice, a clear timeline, the material to be submitted, the work requirements
.
(2) Local selection and recommendation
.
In general hospitals above the second level, based on comprehensive factors such as clinical irrational use of drugs, use amount, clinical value, etc.
, after research and selection by the hospital's Pharmaceutical Affairs Management and Pharmacotherapeutics Committee, they will not distinguish the dosage form and use the generic name of the drug according to the recommended level from strong to For weak ranking, the information of the top 30 varieties with the strongest recommendation degree will be stamped with the official seal of the hospital and submitted to the provincial health administrative department
.
The provincial health administrative department assigns corresponding scores to the 30 varieties recommended by each hospital.
That is, the first-ranked variety is assigned a value of 30, and the second-ranked variety is assigned a value of 29 points.
The 30th place is assigned 1 point
.
On the basis of the generic name of the drug, the provincial health administrative department sums up the assignments of all the varieties submitted by general hospitals above the level of jurisdiction to obtain the total recommended score for each variety, and then follow the scores from high to low.
Sorting (If the score is the same, it can be sorted side by side and occupy subsequent rankings)
.
The information of the top 30 drugs (including other drugs with a tie score for the 30th) will be stamped with the official seal and submitted to the Medical Administration and Hospital Administration of the National Health Commission
.
(3) Expert summary
.
The National Health Commission entrusted the National Pharmaceutical Council to conduct formal review of the materials submitted by various regions, adopting the same calculation method as that of provincial health administrative departments, and deriving the top 30 varieties
.
(4) Announce the results
.
The National Health Commission announced the adjustment results of the catalog, released a new version of the catalog, and put forward management requirements
.
Article 7 All provincial-level health administrative departments shall, based on the 30 drug varieties submitted by the province, include them in the new version of the list of drug varieties, form a provincial-level key monitoring drug list for rational use, and report to the National Health Commission for the record in a timely manner
.
On the basis of the provincial catalog, all medical institutions at all levels, combined with the actual use of drugs, form a list of drugs that the institution focuses on monitoring the rational use of drugs
.
The provincial and medical institutions’ key monitoring and rational use drug catalogs shall be announced to the public in the form of government affairs disclosure, hospital affairs disclosure, and official website announcements as required
.
Article 8 The health administrative departments of all localities should attach great importance to strengthening the management of pharmaceutical affairs in medical institutions, and effectively strengthen the organization and leadership and overall coordination to ensure that the rational use of drugs is in place
.
Formulate and improve clinical application guidelines for related drugs, clarify drug application guidelines and dosing plans, make full use of modern information methods, and strengthen the supervision of rational drug use
.
Article 9 For the drugs adjusted out of the original catalogue, the local health administrative department shall continue to monitor for at least one year, grasp the prescription reviews, usage amount, usage amount, etc.
, to promote the continuous improvement of the level of clinical rational use of drugs
.
Article 10 This regulation shall be implemented from the date of issuance
.
.
The "Regulations" will come into effect on the date of issuance, which may mean that the second edition of the National List of Key Drugs to be Monitored is also about to be released
.
The "Regulations" clarified that the drugs included in the catalogue management should be chemical drugs and biological products that have a lot of unreasonable clinical use, abnormally high usage amounts, and a greater impact on the rationality of medication
.
Key including adjuvant, antineoplastic agents, antimicrobials, proton pump inhibitors, glucocorticoids, parenteral nutrition drugs
.
At least one year of local monitoring is required for drugs to be transferred.
On July 1 , 2019, the National Health Commission and the State Administration of Traditional Chinese Medicine issued the "First Batch of National Key Monitoring Drugs List (Chemical Drugs and Biological Products)", and 20 The use of a variety of drugs is included in the scope of key monitoring
.
On this basis, the provinces have made slight adjustments to it
.
Compared with a total of 20 varieties included in the first batch of catalogs, the number of drug varieties included in catalog management after this adjustment will increase to 30
.
Because the "Regulations" are clear, the number of drug varieties included in the national key monitoring catalogue management is generally 30, and the time for updating and adjusting the catalogue is not less than 3 years in principle
.
Among the drug categories that have been focused on, anti-tumor drugs and proton pump inhibitors are on the list
.
With the increase in the number of cancer patients in China, the reform of the drug regulatory review and approval system has further promoted the development and listing of innovative drugs.
Innovative tumor drugs have become a hot area for pharmaceutical companies to invest heavily
.
Focusing on market segments and clinical needs, truly patient-centered, serious and reasonable use, and benign market competition have attracted the attention of regulatory authorities
.
In this field of treatment, the most importantly monitored should be adjuvant drugs for the treatment of tumor diseases, such as thymopentin, immunosuppressive agents and other types of products.
.
In the category of digestive system chemicals, proton pump inhibitors are used most frequently
.
According to data from Minai.
com, among the top 10 chemical drug sales products, clinically common esomeprazole, lansoprazole, omeprazole, pantoprazole, etc.
are all listed
.
Take Esomeprazole as an example.
In recent years, the terminal sales of the drug in Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) have gradually increased, and the first breakthrough in 2019 5 billion yuan, an increase of 15.
71% year-on-year
.
In 2019, the top 3 terminal esomeprazole manufacturers in China's public medical institutions were AstraZeneca, Chia Tai Tianqing and Chongqing Laimei Pharmaceuticals.
Among them, the original research manufacturer AstraZeneca's market share fell from 98.
66% in 2015 to 2019 While the market share of CP Tianqing has increased year by year, it has exceeded 20% in 2019
.
This time, it has been closely watched by the national key monitoring catalog
.
It remains to be seen which proton pump inhibitors will eventually be included .
The "Regulations" pointed out that the adjustment of the national version of the key monitoring catalog includes four stages: initiation adjustment, local selection and recommendation, expert summary, and announcement of results
.
Among them, in the stage of local selection and recommendation, general hospitals above level 2 can, based on comprehensive factors such as clinical irrational use of drugs, usage amount, clinical value, etc.
, after research and selection by the hospital's Pharmaceutical Management and Pharmacotherapy Committee, they will not distinguish between the dosage form and the drug.
The common names are sorted according to the degree of recommendation from strong to weak, and the information of the top 30 varieties with the strongest recommendation is stamped with the official seal of the hospital and submitted to the provincial health administrative department
.
The provincial health administrative department assigns corresponding scores to the 30 varieties recommended by each hospital.
That is, the first-ranked variety is assigned a value of 30, and the second-ranked variety is assigned a value of 29 points.
The 30th place is assigned 1 point
.
On the basis of the generic name of the drug, the provincial health administrative department sums up the assignments of all the varieties submitted by general hospitals above the level of jurisdiction to obtain the total recommended score for each variety, and then follow the scores from high to low.
Sorting (If the score is the same, it can be sorted side by side and occupy subsequent rankings)
.
The information of the top 30 drugs (including other drugs with a tie score on the 30th) will be stamped with the official seal and submitted to the Medical Administration and Hospital Administration of the National Health Commission
.
It is worth noting that for the drugs adjusted out of the original catalog, the local health administrative department should continue to monitor for at least one year, and grasp their prescription reviews, usage, and usage amount, so as to promote the continuous improvement of the level of clinical rational use of drugs
.
The market for key monitored varieties has shrunk by nearly 80%
.
The restrictions on key monitored varieties do not stop at the national catalogue
.
After the announcement of the first national version of the key-monitored varieties catalogue in 2019, the first batch of key-monitored varieties catalogues of various provinces (cities) have also been announced.
Injections and nutritional injections are the main categories supplemented by the provinces
.
For example, the Hubei Provincial Health Commission released the first batch of key monitored drugs catalogues, adding Guhong injection, Shenxiong injection, Lugua polypeptide injection, placental polypeptide injection, and safflower yellow injection to the national version.
Wait for 5 varieties
.
According to statistics from Minai.
com, 11 of the 20 drugs in the first batch of national key monitoring catalogues are over 1 billion varieties, including thymopentin, ribonucleic acid II, invert glucose electrolyte, edaravone injection, calf serum albumin, Oxiracetam, cerebroside carnosine, troxerutin cerebroprotein hydrolysate, creatine phosphate sodium, complex coenzyme and Danshen ligustrazine
.
At present, the work of clearing and retiring provincial-level supplements in the medical insurance catalog is accelerating.
Judging from the adjustments announced by various provinces and cities, the first to be "cleared" by the medical insurance catalog is the key monitoring drug
.
Without the heavy support of the medical insurance catalogue, from the relevant data, the sales of the first batch of key monitoring products included in the national edition have declined significantly
.
The total sales data of the 20 types of sample hospitals in 2018 was 47.
46 billion yuan.
In 2019, the market size dropped to 37.
85 billion yuan and only 10.
98 billion yuan in 2020.
The market shrank by nearly 80%
.
List of key monitoring drugs for enterprisesThe impact is not only on the level of the medical insurance catalog, but also on the centralized procurement of medicines
.
For example, in Zhoushan, Zhejiang, the key monitored drugs will be transferred out of the procurement catalog list in 2019, involving laoxycephalosporin, enoxaparin sodium, reduced glutathione, ceftriaxone sodium, piperacillin sodium, tazobactam sodium, 10 specifications including Bailing Capsules
.
In August 2019, based on the list of key monitored drugs published by the National Health Commission and Qinghai Provincial Health Commission, Qinghai carried out centralized procurement of key monitored drugs with large purchases and high purchase amounts, and the bid price must not be higher than the current national The lowest provincial purchase price (excluding GPO purchase price) is based on the number of bidding companies to decide whether to purchase by bidding or by bargaining/negotiation
.
Wuhan City chose to purchase 30 key clinically monitored varieties through centralized bargaining, and imposed strict restrictions: there is no quantitative agreement for key monitored varieties, and no advance payment of medical insurance funds; at the same time, a maximum price limit (effective quotation) is set for the company.
0.
7 times of the lowest price of the provincial-level online listing for the variety, if it is higher than the highest limit price, the quotation will be invalid
.
Insiders believe that the price cuts of key nationally monitored drugs are a high probability event, and driven by the current national linkage of drug prices, there should be a situation where price cuts in one place will follow the country
.
On the whole, price reduction of medicines is a mainstream trend.
In the future, most medicines, including key monitoring catalogs, will be exchanged for the market through price cuts
.
The National Key
Controlled Drugs Catalogue Adjustment Work Procedures Article 1 is to strengthen the management of clinical rational use of drugs in China, promote the formulation and adjustment of the national key controlled rational use of drugs catalog (hereinafter referred to as the catalog) to be more scientific and reasonable, continuously standardize clinical drug use behavior, and safeguard the people Health rights, formulate this regulation
.
Article 2 The drugs included in the catalogue management should be chemical drugs and biological products that have a lot of unreasonable clinical use, abnormally high amounts of use, and have a greater impact on the rationality of drug use
.
The focus includes adjuvant drugs, anti-tumor drugs, antimicrobial drugs, proton pump inhibitors, glucocorticoids, parenteral nutrition drugs, etc.
.
Article 3 The adjustment of the catalogue adheres to the principle of "openness and transparency, local recommendation, and dynamic adjustment", and aims to standardize clinical drug use and promote rational drug use
.
Article 4 In principle, the time for updating and adjusting the catalog is not less than 3 years, and the number of drug varieties included in catalog management is generally 30
.
Article 5 The National Pharmaceutical Administration and Therapeutics Committee (hereinafter referred to as the National Pharmaceutical Council) provides professional technical support for the scientific adjustment catalog, and undertakes the collection, sorting and analysis of recommended materials from various regions
.
Article 6 The adjustment of the catalogue includes four stages: initiation adjustment, local selection and recommendation, expert summary, and results announcement
.
(1) Start adjustment
.
National health committee released the directory adjustment notice, a clear timeline, the material to be submitted, the work requirements
.
(2) Local selection and recommendation
.
In general hospitals above the second level, based on comprehensive factors such as clinical irrational use of drugs, use amount, clinical value, etc.
, after research and selection by the hospital's Pharmaceutical Affairs Management and Pharmacotherapeutics Committee, they will not distinguish the dosage form and use the generic name of the drug according to the recommended level from strong to For weak ranking, the information of the top 30 varieties with the strongest recommendation degree will be stamped with the official seal of the hospital and submitted to the provincial health administrative department
.
The provincial health administrative department assigns corresponding scores to the 30 varieties recommended by each hospital.
That is, the first-ranked variety is assigned a value of 30, and the second-ranked variety is assigned a value of 29 points.
The 30th place is assigned 1 point
.
On the basis of the generic name of the drug, the provincial health administrative department sums up the assignments of all the varieties submitted by general hospitals above the level of jurisdiction to obtain the total recommended score for each variety, and then follow the scores from high to low.
Sorting (If the score is the same, it can be sorted side by side and occupy subsequent rankings)
.
The information of the top 30 drugs (including other drugs with a tie score for the 30th) will be stamped with the official seal and submitted to the Medical Administration and Hospital Administration of the National Health Commission
.
(3) Expert summary
.
The National Health Commission entrusted the National Pharmaceutical Council to conduct formal review of the materials submitted by various regions, adopting the same calculation method as that of provincial health administrative departments, and deriving the top 30 varieties
.
(4) Announce the results
.
The National Health Commission announced the adjustment results of the catalog, released a new version of the catalog, and put forward management requirements
.
Article 7 All provincial-level health administrative departments shall, based on the 30 drug varieties submitted by the province, include them in the new version of the list of drug varieties, form a provincial-level key monitoring drug list for rational use, and report to the National Health Commission for the record in a timely manner
.
On the basis of the provincial catalog, all medical institutions at all levels, combined with the actual use of drugs, form a list of drugs that the institution focuses on monitoring the rational use of drugs
.
The provincial and medical institutions’ key monitoring and rational use drug catalogs shall be announced to the public in the form of government affairs disclosure, hospital affairs disclosure, and official website announcements as required
.
Article 8 The health administrative departments of all localities should attach great importance to strengthening the management of pharmaceutical affairs in medical institutions, and effectively strengthen the organization and leadership and overall coordination to ensure that the rational use of drugs is in place
.
Formulate and improve clinical application guidelines for related drugs, clarify drug application guidelines and dosing plans, make full use of modern information methods, and strengthen the supervision of rational drug use
.
Article 9 For the drugs adjusted out of the original catalogue, the local health administrative department shall continue to monitor for at least one year, grasp the prescription reviews, usage amount, usage amount, etc.
, to promote the continuous improvement of the level of clinical rational use of drugs
.
Article 10 This regulation shall be implemented from the date of issuance
.
