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On March 3, the Jiangxi Provincial Food and Drug Administration issued an announcement on the second phase of drug supervision and sampling inspection in Jiangxi Province in 2022
.
The announcement shows that in order to strengthen the supervision of drug quality and ensure the safety of public medication, in accordance with the "Drug Administration Law" and related laws and regulations and the Jiangxi Provincial Drug Sampling Plan, the drug regulatory departments and inspection agencies at all levels in Jiangxi Province will conduct inspections on the production, operation and use of drugs in the province.
The unit carried out supervision and sampling inspection
.
According to statistics, a total of 12 batches of medicines from 12 pharmaceutical manufacturers did not meet the regulations.
Among them, Chinese herbal decoction pieces are still "famous on the list", involving many varieties of Chinese medicine decoction pieces such as vinegar turtle Jia, Acanthopanax senticosus, and vinegar Corydalis
.
From the perspective of unqualified items, the main ones are [drug scraps impurities], [content determination], [aflatoxin] and so on
.
For drugs that do not meet the requirements, the Jiangxi Provincial Food and Drug Administration stated that it has instructed relevant departments to take necessary control measures such as sealing, seizure, suspension of sales, recall and other necessary control measures for the drugs that do not meet the regulations, and the production enterprises and sampled units in accordance with relevant laws and regulations.
to investigate
.
The industry said that once substandard traditional Chinese medicine products flow to hospitals or pharmacies and are purchased by consumers, it is likely to endanger life and safety, and is not conducive to the survival and development of the traditional Chinese medicine industry
.
In recent years, China's traditional Chinese medicine decoction pieces industry has developed rapidly.
With the continuous strengthening of drug supervision, the pass rate of Chinese medicine decoction pieces has also been significantly improved
.
However, problems such as processing, counterfeiting, selling counterfeit and non-standard processing still occur frequently in the market
.
The analysis believes that this is mainly related to the backward standards of some Chinese herbal medicines, unscientific cultivation of Chinese herbal medicines, many small workshops with low prices and low quality, and inaccurate supervision methods
.
In the context of the golden development period of the traditional Chinese medicine industry, in order to improve the quality of traditional Chinese medicine decoction pieces, relevant regulatory authorities have always attached great importance to it
.
It is understood that in February 2020, the State Food and Drug Administration issued the "Work Plan for the Special Remediation of Chinese Herbal Pieces", which put forward the overall goals and work points for the special rectification of Chinese Herbal Pieces nationwide
.
On May 12, 2020, the State Food and Drug Administration held a teleconference, requiring drug regulatory authorities at all levels to continuously improve the quality of Chinese herbal decoction pieces in accordance with the "four strictest" requirements
.
On December 30, 2020, the new version of the Pharmacopoeia was officially implemented, and stricter management requirements were also put forward for the production and other aspects of the Chinese herbal medicine industry
.
In addition, on February 24, 2022, the General Department of the State Food and Drug Administration issued a notice on the "Guiding Opinions on the Principles for the Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People's Republic of China", which regulates the administration of traditional Chinese medicine pieces.
Penalty discretion standards for penalty cases
.
The notice refines the quality, scope, application, and punishment principles of related products that "produce and sell Chinese herbal decoction pieces that do not meet drug standards and do not affect safety and effectiveness", and further standardize the handling of administrative penalty cases for Chinese herbal decoction pieces.
Unify the discretionary standards for administrative punishment and guide the investigation and handling of cases in accordance with the law
.
In general, with the implementation of the new policies and regulations, the industry supervision has become stricter, and the reshuffle of the Chinese herbal medicine industry will accelerate in the future
.
In this context, Chinese herbal decoction pieces companies must not have a fluke mentality, and need to regulate their operations and strictly control the quality and safety of Chinese medicines
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
The announcement shows that in order to strengthen the supervision of drug quality and ensure the safety of public medication, in accordance with the "Drug Administration Law" and related laws and regulations and the Jiangxi Provincial Drug Sampling Plan, the drug regulatory departments and inspection agencies at all levels in Jiangxi Province will conduct inspections on the production, operation and use of drugs in the province.
The unit carried out supervision and sampling inspection
.
According to statistics, a total of 12 batches of medicines from 12 pharmaceutical manufacturers did not meet the regulations.
Among them, Chinese herbal decoction pieces are still "famous on the list", involving many varieties of Chinese medicine decoction pieces such as vinegar turtle Jia, Acanthopanax senticosus, and vinegar Corydalis
.
From the perspective of unqualified items, the main ones are [drug scraps impurities], [content determination], [aflatoxin] and so on
.
For drugs that do not meet the requirements, the Jiangxi Provincial Food and Drug Administration stated that it has instructed relevant departments to take necessary control measures such as sealing, seizure, suspension of sales, recall and other necessary control measures for the drugs that do not meet the regulations, and the production enterprises and sampled units in accordance with relevant laws and regulations.
to investigate
.
The industry said that once substandard traditional Chinese medicine products flow to hospitals or pharmacies and are purchased by consumers, it is likely to endanger life and safety, and is not conducive to the survival and development of the traditional Chinese medicine industry
.
In recent years, China's traditional Chinese medicine decoction pieces industry has developed rapidly.
With the continuous strengthening of drug supervision, the pass rate of Chinese medicine decoction pieces has also been significantly improved
.
However, problems such as processing, counterfeiting, selling counterfeit and non-standard processing still occur frequently in the market
.
The analysis believes that this is mainly related to the backward standards of some Chinese herbal medicines, unscientific cultivation of Chinese herbal medicines, many small workshops with low prices and low quality, and inaccurate supervision methods
.
In the context of the golden development period of the traditional Chinese medicine industry, in order to improve the quality of traditional Chinese medicine decoction pieces, relevant regulatory authorities have always attached great importance to it
.
It is understood that in February 2020, the State Food and Drug Administration issued the "Work Plan for the Special Remediation of Chinese Herbal Pieces", which put forward the overall goals and work points for the special rectification of Chinese Herbal Pieces nationwide
.
On May 12, 2020, the State Food and Drug Administration held a teleconference, requiring drug regulatory authorities at all levels to continuously improve the quality of Chinese herbal decoction pieces in accordance with the "four strictest" requirements
.
On December 30, 2020, the new version of the Pharmacopoeia was officially implemented, and stricter management requirements were also put forward for the production and other aspects of the Chinese herbal medicine industry
.
In addition, on February 24, 2022, the General Department of the State Food and Drug Administration issued a notice on the "Guiding Opinions on the Principles for the Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People's Republic of China", which regulates the administration of traditional Chinese medicine pieces.
Penalty discretion standards for penalty cases
.
The notice refines the quality, scope, application, and punishment principles of related products that "produce and sell Chinese herbal decoction pieces that do not meet drug standards and do not affect safety and effectiveness", and further standardize the handling of administrative penalty cases for Chinese herbal decoction pieces.
Unify the discretionary standards for administrative punishment and guide the investigation and handling of cases in accordance with the law
.
In general, with the implementation of the new policies and regulations, the industry supervision has become stricter, and the reshuffle of the Chinese herbal medicine industry will accelerate in the future
.
In this context, Chinese herbal decoction pieces companies must not have a fluke mentality, and need to regulate their operations and strictly control the quality and safety of Chinese medicines
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
