The release of major Chinese medicine documents affects all pharmaceutical companies...

Medical Network News on March 31　

 

Major Chinese medicine documents released

 

Recently, the 30th meeting of the Standing Committee of the 15th Shanghai Municipal People's Congress voted and passed the "Regulations of Shanghai Municipality on Traditional Chinese Medicine," which will come into effect on May 1 this year.

 

According to reports, the "Regulations of Shanghai Municipality on Traditional Chinese Medicine" has nine chapters and 58 articles, with the purpose of protecting, supporting, and promoting the development of Chinese medicine, and insisting on both standardization and support.
Provisions are made for personnel training, inheritance and innovation of traditional Chinese medicine, cultural dissemination and open development, and related guarantees and supervision.
The enactment of this regulation marks the simultaneous repeal of the "Regulations of Shanghai Municipality on the Development of Traditional Chinese Medicine" that came into effect in 1998.

 

Among them, the content of "improving the quality assurance of Chinese medicinal materials and increasing the guarantee of safe medication" deserves the attention of medical professionals.

 

"Regulations" clearly, city development and reform, economic information, Chinese Medicine, the drug regulatory authorities shall take measures to support traditional Chinese medicine production enterprises commonly used in large-scale Chinese herbal medicines in the construction of authentic traditional Chinese medicine origin, standardization, industrialization of plant breeding base , Promote the use of fine varieties and improve the quality of Chinese medicinal materials.

 

In order to make the quality of medicinal materials more controllable, this legislation has increased the construction of the traceability system.
The "Regulations" clarify that pharmaceutical manufacturers who purchase Chinese medicinal materials and Chinese medicinal pieces shall establish a purchase inspection record system in accordance with the law; operators of Chinese medicinal materials and Chinese medicine decoction pieces shall establish a purchase inspection and purchase and sale record system, and indicate the place of origin of the Chinese medicinal materials; encourage drug production Enterprises, operators of Chinese medicinal materials and Chinese medicinal pieces, medical institutions, and industry associations shall establish an information traceability system in accordance with relevant laws, pharmnet.
com.
cn/" target="_blank">regulations and technical standards.

 

　　In addition, in order to change the phenomenon of low prices of traditional Chinese medicine decoction pieces, the "Regulations" have also made it clear that this city relies on relevant industry associations to establish a quality grading and evaluation system for traditional Chinese medicine decoction pieces.

 

　　The quality of Chinese medicinal materials still needs attention

 

　　The country attaches great importance to the development of traditional Chinese medicine .
The 2021 government work report clearly stated that it is necessary to adhere to both Chinese and Western medicine and implement major projects for the revitalization and development of Chinese medicine.
To develop Chinese medicine, the quality of medicinal materials is the foundation.

 

　　A few days ago, the State Food and Drug Administration issued the "National Drug Sampling Inspection Annual Report (2020)".
The report showed that in 2020, the National Drug Sampling Inspection will have a total of 6338 batches of 48 varieties of proprietary Chinese medicines.
After inspection, 34 batches (including 2 batches of product The supplementary inspection method judged that it did not meet the requirements), and batches 1 and 33 of the non-compliant products were detected in the production and operation links, respectively, accounting for 0.
1% and 0.
6% of all samples in the corresponding links.

 

　　In 2020, the State Food and Drug Administration organized a special sampling of Chinese herbal medicines.
A total of 1368 batches of 8 decoction pieces of traditional Chinese medicine were sampled.
After inspection, 1341 batches were in compliance with regulations and 27 batches were not in compliance with regulations.
Non-compliance items mainly involve total ash content (2 batches), properties (23 batches), impurities (2 batches), identification (4 batches) and content determination (1 batch).

 

 

　　The main problems found in the national drug sampling inspections in 2020 are: first, the problem of adulteration and mixed use of genuine and counterfeit products, such as the mixing of some aconites in the production of Sichuan aconite; the second is the problem of excessive harmful residues, such as excessive pesticide residues in some batches of Peucedanum.
; Third, the harvesting and processing are not standardized.
For example, patchouli is not harvested according to the standard method, and some batches of yellow finishing processing are not standardized, causing the total ash content to exceed the standard.

 

 

　　This is related to the poor quality control of Chinese medicinal materials due to the characteristics of Chinese medicine itself, but it is also a manifestation of the immature development of the Chinese medicinal materials industry.
However, with the launch of a series of special rectifications in response to this problem, the overall quality of Chinese herbal medicines has improved significantly.

 

　　From the comparison of the national market quality sampling data from 2013 to 2019, the overall pass rates of Chinese herbal medicines and decoction pieces are 64%, 68%, 75%, 77%, 84%, 88%, 91%, although there are still some Problems, but it shows a trend of improving year by year and steadily improving.

 

　　Medication safety needs to be improved

 

　　In addition to the quality of medicinal materials, the safety issues in the use of medicinal materials are also worth noting.

 

　　Recently, the National Adverse Drug Reaction Monitoring Center of the State Food and Drug Administration issued the "Annual Report on National Adverse Drug Reaction Monitoring (2020)".
The report shows that in 2020, the National Adverse Drug Reaction Monitoring Network received a total of 830,000 reports of adverse reactions/events included in the National Essential Drug List (2018 Edition), involving 105,000 cases of proprietary Chinese medicines, accounting for 11.
9%.
Among them, 6,358 cases were severely reported, accounting for 6.
0%.

 

　　Compared with 2019, the number of TCM adverse reaction/event reports will increase in 2020, but the proportion of serious reports will decrease.
It is worth noting that the increase in the number of adverse reaction reports does not mean that the level of drug safety has fallen, but that the information held by the regulatory authorities is becoming more and more comprehensive.
From the overall situation, the proportion of traditional Chinese medicine in the overall adverse reaction/event report is on a downward trend in 2020, but medication safety still needs to be paid attention to.

 

　　A very important problem with the safety of traditional Chinese medicine is that the instructions are not perfect.
Due to historical reasons, most of the instructions for traditional Chinese medicine retain the original simple way of writing, and the columns for adverse reactions, contraindications, and precautions are mostly "unclear".
But today, this problem has reached a time when it must be resolved.
"

 

　　According to eight points of health news, in recent years, more than 107 proprietary Chinese medicines have been approved by the National Medical Products Administration to revise the contents of the drug inserts.
The safety items are the focus of the revision.
95%.

 

　　In addition, the standardized use of Chinese medicinal materials is also an important aspect of drug safety that cannot be ignored.
The "Regulations of Shanghai Municipality on Traditional Chinese Medicine" also mentioned the standard problem of substitute decoction to ensure the quality of substitute decoction service and to ensure the curative effect of traditional Chinese medicine.

 

　　On March 29, the Information Office of the State Council held a press conference.
Yu Wenming, director of the State Administration of Traditional Chinese Medicine, and relevant persons in charge of the National Development and Reform Commission introduced the in-depth implementation of the "14th Five-Year Plan" and the promotion of the revitalization and development of Chinese medicine.
It was mentioned at the meeting that during the "14th Five-Year Plan" period, the Bureau of Traditional Chinese Medicine will focus on high-quality development, promote inheritance innovation and improve the quality of traditional Chinese medicine; focus on institutional and mechanism reforms, and create a good policy environment.

 

　　Yu Wenming said that the traditional Chinese medicine system will take advantage of the trend, take responsibility, inherit the essence, maintain integrity and innovate, promote the revitalization and development of traditional Chinese medicine, and make new contributions to improving the health and well-being of the people, building a healthy China and building a modern socialist country.
With more and more Chinese medicine to improve relevant laws and regulations, local policies have been put in the development of Chinese medicine, Chinese medicine believe that hair show getting better and better.

Medical Network News on March 31　

 

　　Major Chinese medicine documents released

 

　　Recently, the 30th meeting of the Standing Committee of the 15th Shanghai Municipal People's Congress voted and passed the "Regulations of Shanghai Municipality on Traditional Chinese Medicine," which will come into effect on May 1 this year.

 

　　According to reports, the "Regulations of Shanghai Municipality on Traditional Chinese Medicine" has nine chapters and 58 articles, with the purpose of protecting, supporting, and promoting the development of Chinese medicine, and insisting on both standardization and support.
Provisions are made for personnel training, inheritance and innovation of traditional Chinese medicine, cultural dissemination and open development, and related guarantees and supervision.
The enactment of this regulation marks the simultaneous repeal of the "Regulations of Shanghai Municipality on the Development of Traditional Chinese Medicine" that came into effect in 1998.

 

　　Among them, the content of "improving the quality assurance of Chinese medicinal materials and increasing the guarantee of safe medication" deserves the attention of medical professionals.

 

　　"Regulations" clearly, city development and reform, economic information, Chinese Medicine, the drug regulatory authorities shall take measures to support traditional Chinese medicine production enterprises commonly used in large-scale Chinese herbal medicines in the construction of authentic traditional Chinese medicine origin, standardization, industrialization of plant breeding base , Promote the use of fine varieties and improve the quality of Chinese medicinal materials.

 

　　In order to make the quality of medicinal materials more controllable, this legislation has increased the construction of the traceability system.
The "Regulations" clarify that pharmaceutical manufacturers who purchase Chinese medicinal materials and Chinese medicinal pieces shall establish a purchase inspection record system in accordance with the law; operators of Chinese medicinal materials and Chinese medicine decoction pieces shall establish a purchase inspection and purchase and sale record system, and indicate the place of origin of the Chinese medicinal materials; encourage drug production Enterprises, operators of Chinese medicinal materials and Chinese medicinal pieces, medical institutions, and industry associations shall establish an information traceability system in accordance with relevant laws, pharmnet.
com.
cn/" target="_blank">regulations and technical standards.

 

　　In addition, in order to change the phenomenon of low prices of traditional Chinese medicine decoction pieces, the "Regulations" have also made it clear that this city relies on relevant industry associations to establish a quality grading and evaluation system for traditional Chinese medicine decoction pieces.

 

　　The quality of Chinese medicinal materials still needs attention

 

　　The country attaches great importance to the development of traditional Chinese medicine .
The 2021 government work report clearly stated that it is necessary to adhere to both Chinese and Western medicine and implement major projects for the revitalization and development of Chinese medicine.
To develop Chinese medicine, the quality of medicinal materials is the foundation.

 

　　A few days ago, the State Food and Drug Administration issued the "National Drug Sampling Inspection Annual Report (2020)".
The report showed that in 2020, the National Drug Sampling Inspection will have a total of 6338 batches of 48 varieties of proprietary Chinese medicines.
After inspection, 34 batches (including 2 batches of product The supplementary inspection method judged that it did not meet the requirements), and batches 1 and 33 of the non-compliant products were detected in the production and operation links, respectively, accounting for 0.
1% and 0.
6% of all samples in the corresponding links.

 

　　In 2020, the State Food and Drug Administration organized a special sampling of Chinese herbal medicines.
A total of 1368 batches of 8 decoction pieces of traditional Chinese medicine were sampled.
After inspection, 1341 batches were in compliance with regulations and 27 batches were not in compliance with regulations.
Non-compliance items mainly involve total ash content (2 batches), properties (23 batches), impurities (2 batches), identification (4 batches) and content determination (1 batch).

 

 

　　The main problems found in the national drug sampling inspections in 2020 are: first, the problem of adulteration and mixed use of genuine and counterfeit products, such as the mixing of some aconites in the production of Sichuan aconite; the second is the problem of excessive harmful residues, such as excessive pesticide residues in some batches of Peucedanum.
; Third, the harvesting and processing are not standardized.
For example, patchouli is not harvested according to the standard method, and some batches of yellow finishing processing are not standardized, causing the total ash content to exceed the standard.

 

 

　　This is related to the poor quality control of Chinese medicinal materials due to the characteristics of Chinese medicine itself, but it is also a manifestation of the immature development of the Chinese medicinal materials industry.
However, with the launch of a series of special rectifications in response to this problem, the overall quality of Chinese herbal medicines has improved significantly.

 

　　From the comparison of the national market quality sampling data from 2013 to 2019, the overall pass rates of Chinese herbal medicines and decoction pieces are 64%, 68%, 75%, 77%, 84%, 88%, 91%, although there are still some Problems, but it shows a trend of improving year by year and steadily improving.

 

　　Medication safety needs to be improved

 

　　In addition to the quality of medicinal materials, the safety issues in the use of medicinal materials are also worth noting.

 

　　Recently, the National Adverse Drug Reaction Monitoring Center of the State Food and Drug Administration issued the "Annual Report on National Adverse Drug Reaction Monitoring (2020)".
The report shows that in 2020, the National Adverse Drug Reaction Monitoring Network received a total of 830,000 reports of adverse reactions/events included in the National Essential Drug List (2018 Edition), involving 105,000 cases of proprietary Chinese medicines, accounting for 11.
9%.
Among them, 6,358 cases were severely reported, accounting for 6.
0%.

 

　　Compared with 2019, the number of TCM adverse reaction/event reports will increase in 2020, but the proportion of serious reports will decrease.
It is worth noting that the increase in the number of adverse reaction reports does not mean that the level of drug safety has fallen, but that the information held by the regulatory authorities is becoming more and more comprehensive.
From the overall situation, the proportion of traditional Chinese medicine in the overall adverse reaction/event report is on a downward trend in 2020, but medication safety still needs to be paid attention to.

 

　　A very important problem with the safety of traditional Chinese medicine is that the instructions are not perfect.
Due to historical reasons, most of the instructions for traditional Chinese medicine retain the original simple way of writing, and the columns for adverse reactions, contraindications, and precautions are mostly "unclear".
But today, this problem has reached a time when it must be resolved.
"

 

　　According to eight points of health news, in recent years, more than 107 proprietary Chinese medicines have been approved by the National Medical Products Administration to revise the contents of the drug inserts.
The safety items are the focus of the revision.
95%.

 

　　In addition, the standardized use of Chinese medicinal materials is also an important aspect of drug safety that cannot be ignored.
The "Regulations of Shanghai Municipality on Traditional Chinese Medicine" also mentioned the standard problem of substitute decoction to ensure the quality of substitute decoction service and to ensure the curative effect of traditional Chinese medicine.

 

　　On March 29, the Information Office of the State Council held a press conference.
Yu Wenming, director of the State Administration of Traditional Chinese Medicine, and relevant persons in charge of the National Development and Reform Commission introduced the in-depth implementation of the "14th Five-Year Plan" and the promotion of the revitalization and development of Chinese medicine.
It was mentioned at the meeting that during the "14th Five-Year Plan" period, the Bureau of Traditional Chinese Medicine will focus on high-quality development, promote inheritance innovation and improve the quality of traditional Chinese medicine; focus on institutional and mechanism reforms, and create a good policy environment.

 

　　Yu Wenming said that the traditional Chinese medicine system will take advantage of the trend, take responsibility, inherit the essence, maintain integrity and innovate, promote the revitalization and development of traditional Chinese medicine, and make new contributions to improving the health and well-being of the people, building a healthy China and building a modern socialist country.
With more and more Chinese medicine to improve relevant laws and regulations, local policies have been put in the development of Chinese medicine, Chinese medicine believe that hair show getting better and better.