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Based on this situation, in August 2015, in accordance with the spirit of the State Council’s Document No.
44, the State Food and Drug Administration launched the reform of drug and medical device review and approval, and started the implementation of the evaluation of the quality and efficacy of generic drugs.
In March 2016, the State Council issued No.
8 Document on the Opinions on Conducting the Consistency Evaluation of Generic Drugs.
As of the end of 2019, the State Food and Drug Administration had reviewed and passed a total of 385 applications for consistency evaluation of product regulations, involving 134 varieties.
A total of 22 batches of reference preparation catalogues with a total of 1899 product specifications have been released.
44, the State Food and Drug Administration launched the reform of drug and medical device review and approval, and started the implementation of the evaluation of the quality and efficacy of generic drugs.
In March 2016, the State Council issued No.
8 Document on the Opinions on Conducting the Consistency Evaluation of Generic Drugs.
As of the end of 2019, the State Food and Drug Administration had reviewed and passed a total of 385 applications for consistency evaluation of product regulations, involving 134 varieties.
A total of 22 batches of reference preparation catalogues with a total of 1899 product specifications have been released.
According to generics conformance assessment deadlines, the first production enterprises varieties by the consistency of evaluation, the other drug manufacturers with its production of the same species, in principle, to evaluate the agreement should be completed within three years.
Drugs that have been assessed as being clinically necessary and in short supply on the market can apply for extension, and those that have not been completed after the expiry date will not be re-registered.
Drugs that have been assessed as being clinically necessary and in short supply on the market can apply for extension, and those that have not been completed after the expiry date will not be re-registered.
At present, with the in-depth progress of the consistency evaluation work, the survival of the fittest has become inevitable.
The cost of uniformity evaluation of generic drugs of more than 10 million has caused more and more companies to rethink their own survival strategies, stop production and switch production, and withdraw from the market.
This has promoted the concentration of the industry to a certain extent.
The cost of uniformity evaluation of generic drugs of more than 10 million has caused more and more companies to rethink their own survival strategies, stop production and switch production, and withdraw from the market.
This has promoted the concentration of the industry to a certain extent.
Low drug prices make pharmaceutical companies withdraw from the market
The drugs with the highest number of cancellations this time are acetaminophen tablets and captopril tablets, and seven approvals have been cancelled respectively.
According to the information from Minai.
com, there are 297 registration approvals for captopril tablets and 51 manufacturers.
In the latest bidding information on January 27, the winning company is Jiangsu Tasly, and the winning price is 0.
0544 yuan/25mg, acetaminophen The tablet has 911 registration approvals and 551 manufacturers.
In the latest bidding information, the winning company is Sichuan Yike Pharmaceutical, and the winning price is 0.
047 yuan/500mg.
com, there are 297 registration approvals for captopril tablets and 51 manufacturers.
In the latest bidding information on January 27, the winning company is Jiangsu Tasly, and the winning price is 0.
0544 yuan/25mg, acetaminophen The tablet has 911 registration approvals and 551 manufacturers.
In the latest bidding information, the winning company is Sichuan Yike Pharmaceutical, and the winning price is 0.
047 yuan/500mg.
In addition, in the field of captopril tablets where the national centralized procurement competition is hot, 8 pharmaceutical companies have won the bids in the centralized procurement.
These 8 winning companies have basically achieved ultra-low prices, and the quotations are between 1 and 3 cents.
.
Centralized procurement has undoubtedly increased the fierce competition in the market for these drugs.
These 8 winning companies have basically achieved ultra-low prices, and the quotations are between 1 and 3 cents.
.
Centralized procurement has undoubtedly increased the fierce competition in the market for these drugs.
Such drugs with low prices and fierce market competition, pharmaceutical companies have low profits and declining production willingness, will also choose to cancel the approval and reconsider the development direction.
It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
Attached:
Medical Network News on March 3, the State Food and Drug Administration issued an announcement announcing the cancellation of 226 drug registration certificates including bromelain enteric-coated tablets
226 drugs written off
It is understood that a total of 226 drug registration certificates of 18 pharmaceutical companies have been publicized and cancelled: mainly involving Jiangsu Huanghe Pharmaceutical Co.
, Ltd.
, Fuzhou Neptunus Fu Pharmaceutical Co.
, Ltd.
, Fujian Guangshengtang Pharmaceutical Co.
, Ltd.
, and Fuzhou Pingshan Pharmaceutical Co.
, Ltd.
Company, Fujian Yannian Pharmaceutical Co.
, Ltd.
, Fujian Dongrui Pharmaceutical Co.
, Ltd.
, Inner Mongolia Yuhangren Pharmaceutical Co.
, Ltd.
, Sino-US Shanghai Squibb Pharmaceutical Co.
, Ltd.
, etc.
, Ltd.
, Fuzhou Neptunus Fu Pharmaceutical Co.
, Ltd.
, Fujian Guangshengtang Pharmaceutical Co.
, Ltd.
, and Fuzhou Pingshan Pharmaceutical Co.
, Ltd.
Company, Fujian Yannian Pharmaceutical Co.
, Ltd.
, Fujian Dongrui Pharmaceutical Co.
, Ltd.
, Inner Mongolia Yuhangren Pharmaceutical Co.
, Ltd.
, Sino-US Shanghai Squibb Pharmaceutical Co.
, Ltd.
, etc.
The pharmaceutical company with the largest number of registration certificates is Jiangsu Huanghe Pharmaceutical Co.
, Ltd.
, which has 90 drug approval document numbers to apply for cancellation, accounting for 2/3 of its total number of approvals; Fuzhou Neptunus Pharmaceutical Co.
, Ltd.
also has 25 approval documents No.
application for cancellation.
, Ltd.
, which has 90 drug approval document numbers to apply for cancellation, accounting for 2/3 of its total number of approvals; Fuzhou Neptunus Pharmaceutical Co.
, Ltd.
also has 25 approval documents No.
application for cancellation.
There are relatively many varieties involved, including Norfloxacin Capsules, Rifampicin Capsules, Ranitidine Hydrochloride Capsules, Tetracycline Tablets, Oxytetracycline Tablets, Acetaminophen Tablets, Analgin Tablets, Vitamin B1 Tablets, vitamin B6 tablets, erythromycin enteric-coated tablets, isoniazid tablets, naproxen capsules, aminokahuangmin capsules and other varieties.
In total, among the 226 drugs that were cancelled, tablets were the most, with a total of 137; followed by injections and capsules, with 40 and 37 respectively.
Most of the drugs are canceled in accordance with the application for cancellation, which is the company's initiative to apply for cancellation of the holding approval document, and only 14 drugs are not re-registered.
Six reasons to cancel the approval
According to Article 110 of the current "Administrative Measures for Drug Registration", in any of the following circumstances, the State Drug Administration shall cancel the drug registration certificate and publish it:
1.
The validity period of the approval certificate has not expired, and the applicant proposes to cancel the drug approval number by himself;
The validity period of the approval certificate has not expired, and the applicant proposes to cancel the drug approval number by himself;
2.
Re-registration is not granted in accordance with the provisions of Article 126 of these Measures;
Re-registration is not granted in accordance with the provisions of Article 126 of these Measures;
3.
The "Drug Production License" has been revoked or cancelled according to law;
The "Drug Production License" has been revoked or cancelled according to law;
4.
In accordance with the provisions of Article 42 of the "Drug Administration Law" and Article 41 of the "Implementation Regulations of the Drug Administration Law", the approval document is revoked for drugs that have serious adverse reactions or endanger human health for other reasons;
In accordance with the provisions of Article 42 of the "Drug Administration Law" and Article 41 of the "Implementation Regulations of the Drug Administration Law", the approval document is revoked for drugs that have serious adverse reactions or endanger human health for other reasons;
5.
The administrative penalty decision to revoke the drug approval certificate is made in accordance with the law;
The administrative penalty decision to revoke the drug approval certificate is made in accordance with the law;
6.
Other circumstances where the drug approval certificate should be revoked or withdrawn in accordance with the law.
Other circumstances where the drug approval certificate should be revoked or withdrawn in accordance with the law.
In addition to the cancellation of the "Administrative Measures for Drug Registration", under the consistency evaluation and other policies, some pharmaceutical companies are forced to cancel the drug approvals and withdraw from the market under the pressure of operation.
In addition, for some drugs with low profits and high competitive pressure, manufacturers will also choose to take the initiative to cancel.
Consistency evaluation compresses the generic drug market
Previously, China’s generic drug industry had a low degree of concentration and serious approvals.
Among the current 189,000 drug approvals, 95% were generic drug approvals.
Pharmaceutical companies were almost dominated by generic drugs.
The market size reached about 500 billion yuan, accounting for the total.
About 40% of the pharmaceutical consumer market, while the sales of TOP10 companies in the sample hospital market accounted for only 21.
5%
Among the current 189,000 drug approvals, 95% were generic drug approvals.
Pharmaceutical companies were almost dominated by generic drugs.
The market size reached about 500 billion yuan, accounting for the total.
About 40% of the pharmaceutical consumer market, while the sales of TOP10 companies in the sample hospital market accounted for only 21.
5%
This situation has resulted in a large number of low-level redundant construction in the pharmaceutical market, serious homogenization competition, and very low utilization rate of pharmaceutical product production capacity.
Based on this situation, in August 2015, in accordance with the spirit of the State Council’s Document No.
44, the State Food and Drug Administration launched the reform of drug and medical device review and approval, and started the implementation of the evaluation of the quality and efficacy of generic drugs.
In March 2016, the State Council issued No.
8 Document on the Opinions on Conducting the Consistency Evaluation of Generic Drugs.
As of the end of 2019, the State Food and Drug Administration had reviewed and passed a total of 385 applications for consistency evaluation of product regulations, involving 134 varieties.
A total of 22 batches of reference preparation catalogues with a total of 1899 product specifications have been released.
44, the State Food and Drug Administration launched the reform of drug and medical device review and approval, and started the implementation of the evaluation of the quality and efficacy of generic drugs.
In March 2016, the State Council issued No.
8 Document on the Opinions on Conducting the Consistency Evaluation of Generic Drugs.
As of the end of 2019, the State Food and Drug Administration had reviewed and passed a total of 385 applications for consistency evaluation of product regulations, involving 134 varieties.
A total of 22 batches of reference preparation catalogues with a total of 1899 product specifications have been released.
According to generics conformance assessment deadlines, the first production enterprises varieties by the consistency of evaluation, the other drug manufacturers with its production of the same species, in principle, to evaluate the agreement should be completed within three years.
Drugs that have been assessed as being clinically necessary and in short supply on the market can apply for extension, and those that have not been completed after the expiry date will not be re-registered.
Drugs that have been assessed as being clinically necessary and in short supply on the market can apply for extension, and those that have not been completed after the expiry date will not be re-registered.
At present, with the in-depth progress of the consistency evaluation work, the survival of the fittest has become inevitable.
The cost of uniformity evaluation of generic drugs of more than 10 million has caused more and more companies to rethink their own survival strategies, stop production and switch production, and withdraw from the market.
This has promoted the concentration of the industry to a certain extent.
The cost of uniformity evaluation of generic drugs of more than 10 million has caused more and more companies to rethink their own survival strategies, stop production and switch production, and withdraw from the market.
This has promoted the concentration of the industry to a certain extent.
Low drug prices make pharmaceutical companies withdraw from the market
The drugs with the highest number of cancellations this time are acetaminophen tablets and captopril tablets, and seven approvals have been cancelled respectively.
According to the information from Minai.
com, there are 297 registration approvals for captopril tablets and 51 manufacturers.
In the latest bidding information on January 27, the winning company is Jiangsu Tasly, and the winning price is 0.
0544 yuan/25mg, acetaminophen The tablet has 911 registration approvals and 551 manufacturers.
In the latest bidding information, the winning company is Sichuan Yike Pharmaceutical, and the winning price is 0.
047 yuan/500mg.
com, there are 297 registration approvals for captopril tablets and 51 manufacturers.
In the latest bidding information on January 27, the winning company is Jiangsu Tasly, and the winning price is 0.
0544 yuan/25mg, acetaminophen The tablet has 911 registration approvals and 551 manufacturers.
In the latest bidding information, the winning company is Sichuan Yike Pharmaceutical, and the winning price is 0.
047 yuan/500mg.
In addition, in the field of captopril tablets where the national centralized procurement competition is hot, 8 pharmaceutical companies have won the bids in the centralized procurement.
These 8 winning companies have basically achieved ultra-low prices, and the quotations are between 1 and 3 cents.
.
Centralized procurement has undoubtedly increased the fierce competition in the market for these drugs.
These 8 winning companies have basically achieved ultra-low prices, and the quotations are between 1 and 3 cents.
.
Centralized procurement has undoubtedly increased the fierce competition in the market for these drugs.
Such drugs with low prices and fierce market competition, pharmaceutical companies have low profits and declining production willingness, will also choose to cancel the approval and reconsider the development direction.
It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
Attached:
Medical Network News on March 3, the State Food and Drug Administration issued an announcement announcing the cancellation of 226 drug registration certificates including bromelain enteric-coated tablets
226 drugs written off
226 drugs written off It is understood that a total of 226 drug registration certificates of 18 pharmaceutical companies have been publicized and cancelled: mainly involving Jiangsu Huanghe Pharmaceutical Co.
, Ltd.
, Fuzhou Neptunus Fu Pharmaceutical Co.
, Ltd.
, Fujian Guangshengtang Pharmaceutical Co.
, Ltd.
, and Fuzhou Pingshan Pharmaceutical Co.
, Ltd.
Company, Fujian Yannian Pharmaceutical Co.
, Ltd.
, Fujian Dongrui Pharmaceutical Co.
, Ltd.
, Inner Mongolia Yuhangren Pharmaceutical Co.
, Ltd.
, Sino-US Shanghai Squibb Pharmaceutical Co.
, Ltd.
, etc.
Medicine, medicine, medicine, Ltd.
, Fuzhou Neptunus Fu Pharmaceutical Co.
, Ltd.
, Fujian Guangshengtang Pharmaceutical Co.
, Ltd.
, and Fuzhou Pingshan Pharmaceutical Co.
, Ltd.
Company, Fujian Yannian Pharmaceutical Co.
, Ltd.
, Fujian Dongrui Pharmaceutical Co.
, Ltd.
, Inner Mongolia Yuhangren Pharmaceutical Co.
, Ltd.
, Sino-US Shanghai Squibb Pharmaceutical Co.
, Ltd.
, etc.
The pharmaceutical company with the largest number of registration certificates is Jiangsu Huanghe Pharmaceutical Co.
, Ltd.
, which has 90 drug approval document numbers to apply for cancellation, accounting for 2/3 of its total number of approvals; Fuzhou Neptunus Pharmaceutical Co.
, Ltd.
also has 25 approval documents No.
application for cancellation.
, Ltd.
, which has 90 drug approval document numbers to apply for cancellation, accounting for 2/3 of its total number of approvals; Fuzhou Neptunus Pharmaceutical Co.
, Ltd.
also has 25 approval documents No.
application for cancellation.
There are relatively many varieties involved, including Norfloxacin Capsules, Rifampicin Capsules, Ranitidine Hydrochloride Capsules, Tetracycline Tablets, Oxytetracycline Tablets, Acetaminophen Tablets, Analgin Tablets, Vitamin B1 Tablets, vitamin B6 tablets, erythromycin enteric-coated tablets, isoniazid tablets, naproxen capsules, aminokahuangmin capsules and other varieties.
In total, among the 226 drugs that were cancelled, tablets were the most, with a total of 137; followed by injections and capsules, with 40 and 37 respectively.
Most of the drugs are canceled in accordance with the application for cancellation, which is the company's initiative to apply for cancellation of the holding approval document, and only 14 drugs are not re-registered.
Six reasons to cancel the approval
Six reasons to cancel the approval According to Article 110 of the current "Administrative Measures for Drug Registration", in any of the following circumstances, the State Drug Administration shall cancel the drug registration certificate and publish it:
1.
The validity period of the approval certificate has not expired, and the applicant proposes to cancel the drug approval number by himself;
The validity period of the approval certificate has not expired, and the applicant proposes to cancel the drug approval number by himself;
2.
Re-registration is not granted in accordance with the provisions of Article 126 of these Measures;
Re-registration is not granted in accordance with the provisions of Article 126 of these Measures;
3.
The "Drug Production License" has been revoked or cancelled according to law;
The "Drug Production License" has been revoked or cancelled according to law;
4.
In accordance with the provisions of Article 42 of the "Drug Administration Law" and Article 41 of the "Implementation Regulations of the Drug Administration Law", the approval document is revoked for drugs that have serious adverse reactions or endanger human health for other reasons;
In accordance with the provisions of Article 42 of the "Drug Administration Law" and Article 41 of the "Implementation Regulations of the Drug Administration Law", the approval document is revoked for drugs that have serious adverse reactions or endanger human health for other reasons;
5.
The administrative penalty decision to revoke the drug approval certificate is made in accordance with the law;
The administrative penalty decision to revoke the drug approval certificate is made in accordance with the law;
6.
Other circumstances where the drug approval certificate should be revoked or withdrawn in accordance with the law.
Other circumstances where the drug approval certificate should be revoked or withdrawn in accordance with the law.
In addition to the cancellation of the "Administrative Measures for Drug Registration", under the consistency evaluation and other policies, some pharmaceutical companies are forced to cancel the drug approvals and withdraw from the market under the pressure of operation.
In addition, for some drugs with low profits and high competitive pressure, manufacturers will also choose to take the initiative to cancel.
Consistency evaluation compresses the generic drug market
Consistency evaluation compresses the generic drug market Previously, China’s generic drug industry had a low degree of concentration and serious approvals.
Among the current 189,000 drug approvals, 95% were generic drug approvals.
Pharmaceutical companies were almost dominated by generic drugs.
The market size reached about 500 billion yuan, accounting for the total.
About 40% of the pharmaceutical consumer market, while the sales of TOP10 companies in the sample hospital market accounted for only 21.
5%
Hospital hospital hospitalAmong the current 189,000 drug approvals, 95% were generic drug approvals.
Pharmaceutical companies were almost dominated by generic drugs.
The market size reached about 500 billion yuan, accounting for the total.
About 40% of the pharmaceutical consumer market, while the sales of TOP10 companies in the sample hospital market accounted for only 21.
5%
This situation has resulted in a large number of low-level redundant construction in the pharmaceutical market, serious homogenization competition, and very low utilization rate of pharmaceutical product production capacity.
Medicine Medicine Medicine Based on this situation, in August 2015, in accordance with the spirit of the State Council’s Document No.
44, the State Food and Drug Administration launched the reform of drug and medical device review and approval, and started the implementation of the evaluation of the quality and efficacy of generic drugs.
In March 2016, the State Council issued No.
8 Document on the Opinions on Conducting the Consistency Evaluation of Generic Drugs.
As of the end of 2019, the State Food and Drug Administration had reviewed and passed a total of 385 applications for consistency evaluation of product regulations, involving 134 varieties.
A total of 22 batches of reference preparation catalogues with a total of 1899 product specifications have been released.
Medical equipment medical equipment medical equipment44, the State Food and Drug Administration launched the reform of drug and medical device review and approval, and started the implementation of the evaluation of the quality and efficacy of generic drugs.
In March 2016, the State Council issued No.
8 Document on the Opinions on Conducting the Consistency Evaluation of Generic Drugs.
As of the end of 2019, the State Food and Drug Administration had reviewed and passed a total of 385 applications for consistency evaluation of product regulations, involving 134 varieties.
A total of 22 batches of reference preparation catalogues with a total of 1899 product specifications have been released.
According to generics conformance assessment deadlines, the first production enterprises varieties by the consistency of evaluation, the other drug manufacturers with its production of the same species, in principle, to evaluate the agreement should be completed within three years.
Drugs that have been assessed as being clinically necessary and in short supply on the market can apply for extension, and those that have not been completed after the expiry date will not be re-registered.
Enterprise business enterpriseDrugs that have been assessed as being clinically necessary and in short supply on the market can apply for extension, and those that have not been completed after the expiry date will not be re-registered.
At present, with the in-depth progress of the consistency evaluation work, the survival of the fittest has become inevitable.
The cost of uniformity evaluation of generic drugs of more than 10 million has caused more and more companies to rethink their own survival strategies, stop production and switch production, and withdraw from the market.
This has promoted the concentration of the industry to a certain extent.
The cost of uniformity evaluation of generic drugs of more than 10 million has caused more and more companies to rethink their own survival strategies, stop production and switch production, and withdraw from the market.
This has promoted the concentration of the industry to a certain extent.
Low drug prices make pharmaceutical companies withdraw from the market
Low drug prices make pharmaceutical companies withdraw from the market The drugs with the highest number of cancellations this time are acetaminophen tablets and captopril tablets, and seven approvals have been cancelled respectively.
According to the information from Minai.
com, there are 297 registration approvals for captopril tablets and 51 manufacturers.
In the latest bidding information on January 27, the winning company is Jiangsu Tasly, and the winning price is 0.
0544 yuan/25mg, acetaminophen The tablet has 911 registration approvals and 551 manufacturers.
In the latest bidding information, the winning company is Sichuan Yike Pharmaceutical, and the winning price is 0.
047 yuan/500mg.
com, there are 297 registration approvals for captopril tablets and 51 manufacturers.
In the latest bidding information on January 27, the winning company is Jiangsu Tasly, and the winning price is 0.
0544 yuan/25mg, acetaminophen The tablet has 911 registration approvals and 551 manufacturers.
In the latest bidding information, the winning company is Sichuan Yike Pharmaceutical, and the winning price is 0.
047 yuan/500mg.
In addition, in the field of captopril tablets where the national centralized procurement competition is hot, 8 pharmaceutical companies have won the bids in the centralized procurement.
These 8 winning companies have basically achieved ultra-low prices, and the quotations are between 1 and 3 cents.
.
Centralized procurement has undoubtedly increased the fierce competition in the market for these drugs.
These 8 winning companies have basically achieved ultra-low prices, and the quotations are between 1 and 3 cents.
.
Centralized procurement has undoubtedly increased the fierce competition in the market for these drugs.
Such drugs with low prices and fierce market competition, pharmaceutical companies have low profits and declining production willingness, will also choose to cancel the approval and reconsider the development direction.
It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
It can be judged that the effective utilization rate of approval documents in the past three years will continue to increase, and there will be more cancellation of approval documents.
Attached:
