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The policy of Chinese herbal medicine in one place is relaxed, and pharmacies can be exempted from fines of 100,000
.
.
The policy of Chinese herbal decoction pieces is relaxed, and pharmacies can be exempted from fines of 100,000
A few days ago, the Jiangsu Food and Drug Administration issued the "Guiding Opinions on the Determination of Jiangsu Province Traditional Chinese Medicine Pieces Do Not Comply with Drug Standards and Does Not Affect Safety and Effectiveness (Trial)" (hereinafter referred to as "Opinions")
.
.
The "Opinions" stated that the determination of whether the TCM decoction pieces that do not meet the drug standards "does not affect the safety and effectiveness" does not change the conclusion that "does not meet the drug standards (determined as inferior drugs)"
.
.
In addition, the "Opinions" provide a variety of situations for the properties, moisture, ash, and impurities of TCM decoction pieces that do not meet the standard requirements, so as to determine that the safety and effectiveness of TCM decoction pieces have not been affected
.
Details are as follows:
.
Details are as follows:
1.
Character item
Character item
2.
Moisture
Moisture
3.
Ash
Ash
4.
Impurities
Impurities
The "Opinions" also mentioned that in the investigation and handling of cases, drug supervision and administration departments at all levels should, in accordance with this Opinion, combined with the specific circumstances of non-compliance with drug standards and the relevant illegal facts identified, determine whether the "safety and effectiveness" are affected.
"Make a comprehensive judgment
.
"Make a comprehensive judgment
.
If it is still difficult to identify a special variety based on this opinion, or if the parties have objections to the identification result, the relevant personnel may organize expert discussions and put forward technical opinions on the determination
.
.
According to the relevant provisions of the "Drug Administration Law", if the production or sale of Chinese herbal decoction pieces does not meet the drug standards and does not affect the safety and effectiveness, it shall be ordered to make corrections within a time limit and given a warning; a fine of not less than 100,000 yuan but not more than 500,000 yuan may be imposed.
.
In addition, those who produce and sell inferior medicines will be fined 100,000 yuan
.
.
In addition, those who produce and sell inferior medicines will be fined 100,000 yuan
.
It can be seen that if a pharmacy sells TCM decoction pieces that do not meet the standards, as long as it meets the requirements of the "Opinions" and is deemed to "do not affect the safety and effectiveness", the fine of 100,000 yuan can be waived
.
.
The storage of Chinese herbal decoction pieces is a pain point for pharmacies
It is worth noting that the "Opinions", on the premise of "not meeting the drug standards", clarified the parameters of the safety and effectiveness of Chinese herbal decoction pieces
.
.
"Setting a range for the standard of Chinese medicine decoction pieces is a concrete manifestation of the progress of the industry
.
" Du Zhiyong , the person in charge of Rui Health, told Cyberland - pharmacy manager that Chinese medicine decoction pieces and Chinese medicine pursue a unified standard , which does not conform to the actual local situation
.
Taking the moisture and ash content of TCM decoction pieces as an example, the data of different origins of the same medicinal material are obviously different, and there will be differences in the usage of TCM in different regions
.
After the range is given, TCM can be more flexible and effective
.
.
" Du Zhiyong , the person in charge of Rui Health, told Cyberland - pharmacy manager that Chinese medicine decoction pieces and Chinese medicine pursue a unified standard , which does not conform to the actual local situation
.
Taking the moisture and ash content of TCM decoction pieces as an example, the data of different origins of the same medicinal material are obviously different, and there will be differences in the usage of TCM in different regions
.
After the range is given, TCM can be more flexible and effective
.
Du Zhiyong believes that if the regulation is promoted on a wider scale, it will actually be good for pharmacy operations
.
.
At present, the decoction pieces of traditional Chinese medicine sold by pharmacies are purchased from professional medicinal material companies.
The drugs and channels are generally legal and compliant, and there will be no major problems
.
On the contrary, the storage conditions of Chinese medicine decoction pieces are relatively high, and pharmacies are prone to violations if they are not careful
.
After the regulation is relaxed, the storage cost and the risk of non-compliance in pharmacies will be effectively reduced
.
The drugs and channels are generally legal and compliant, and there will be no major problems
.
On the contrary, the storage conditions of Chinese medicine decoction pieces are relatively high, and pharmacies are prone to violations if they are not careful
.
After the regulation is relaxed, the storage cost and the risk of non-compliance in pharmacies will be effectively reduced
.
For pharmacies, the reduction in the storage cost of Chinese herbal decoction pieces means that sales enthusiasm will increase
.
Yu Jie, a pharmacy researcher, said that many small and medium-sized pharmacies are reluctant to sell Chinese herbal decoction pieces, mostly because the conditions such as temperature and humidity are not up to standard
.
.
Yu Jie, a pharmacy researcher, said that many small and medium-sized pharmacies are reluctant to sell Chinese herbal decoction pieces, mostly because the conditions such as temperature and humidity are not up to standard
.
3 kinds of moisture content are related to the safety of traditional Chinese medicine pieces
In addition to Jiangsu, Guangdong has also issued relevant standards to determine the safety and effectiveness of Chinese herbal decoction pieces that "do not meet the drug standards"
.
.
On August 1, 2021, the Guangdong Food and Drug Administration's "Guidelines for the determination of Chinese herbal decoction pieces that do not meet drug standards and do not affect safety and effectiveness" were officially implemented
.
.
The relevant interpretation documents mentioned that the moisture content has an impact on the stability and physical and chemical properties of Chinese herbal decoction pieces, and controlling the moisture can prevent pests or mildew in the process of circulation and storage
.
.
The moisture limit in some TCM decoction pieces standards may not take into account the temperature and humidity differences in different regions of the country when the standards are formulated, and some TCM decoction pieces are more likely to exceed the water content in the warm and humid Guangdong Province
.
.
The Guangdong Food and Drug Administration stated in the document that when the moisture or weight loss on drying items of Chinese herbal medicines do not meet the regulations, whether it affects the safety and effectiveness of the drug, three situations are specifically considered:
1.
If it exceeds 20% (including 20%) of the limit specified in the standard, it can be regarded as not affecting the effectiveness and safety of Chinese herbal pieces
.
If it exceeds 20% (including 20%) of the limit specified in the standard, it can be regarded as not affecting the effectiveness and safety of Chinese herbal pieces
.
2.
If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
The mycotoxin inspection result is in compliance with the regulations, and it can be regarded as not affecting the effectiveness and safety of Chinese herbal decoction pieces.
The mycotoxin inspection result is: Those that do not comply with the regulations can be considered as affecting the safety of Chinese herbal pieces
.
If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
The mycotoxin inspection result is in compliance with the regulations, and it can be regarded as not affecting the effectiveness and safety of Chinese herbal decoction pieces.
The mycotoxin inspection result is: Those that do not comply with the regulations can be considered as affecting the safety of Chinese herbal pieces
.
3.
If it exceeds 30% of the limit specified in the standard, it can be considered as affecting the safety or effectiveness of Chinese herbal decoction pieces
.
If it exceeds 30% of the limit specified in the standard, it can be considered as affecting the safety or effectiveness of Chinese herbal decoction pieces
.
According to incomplete statistics, Jiangsu, Guangdong, Shandong, Anhui and other provinces have issued relevant documents to clarify the safety and effectiveness standards for Chinese herbal decoction pieces that "do not meet the drug standards"
.
.
The policy of Chinese herbal medicine in one place is relaxed, and pharmacies can be exempted from fines of 100,000
.
.
The policy of Chinese herbal decoction pieces is relaxed, and pharmacies can be exempted from fines of 100,000
A few days ago, the Jiangsu Food and Drug Administration issued the "Guiding Opinions on the Determination of Jiangsu Province Traditional Chinese Medicine Pieces Do Not Comply with Drug Standards and Does Not Affect Safety and Effectiveness (Trial)" (hereinafter referred to as "Opinions")
.
.
The "Opinions" stated that the determination of whether the TCM decoction pieces that do not meet the drug standards "does not affect the safety and effectiveness" does not change the conclusion that "does not meet the drug standards (determined as inferior drugs)"
.
.
In addition, the "Opinions" provide a variety of situations for the properties, moisture, ash, and impurities of TCM decoction pieces that do not meet the standard requirements, so as to determine that the safety and effectiveness of TCM decoction pieces have not been affected
.
Details are as follows:
.
Details are as follows:
1.
Character item
Character item
2.
Moisture
Moisture
3.
Ash
Ash
4.
Impurities
Impurities
The "Opinions" also mentioned that in the investigation and handling of cases, drug supervision and administration departments at all levels should, in accordance with this Opinion, combined with the specific circumstances of non-compliance with drug standards and the relevant illegal facts identified, determine whether the "safety and effectiveness" are affected.
"Make a comprehensive judgment
.
"Make a comprehensive judgment
.
If it is still difficult to identify a special variety based on this opinion, or if the parties have objections to the identification result, the relevant personnel may organize expert discussions and put forward technical opinions on the determination
.
.
According to the relevant provisions of the "Drug Administration Law", if the production or sale of Chinese herbal decoction pieces does not meet the drug standards and does not affect the safety and effectiveness, it shall be ordered to make corrections within a time limit and given a warning; a fine of not less than 100,000 yuan but not more than 500,000 yuan may be imposed.
.
In addition, those who produce and sell inferior medicines will be fined 100,000 yuan
.
.
In addition, those who produce and sell inferior medicines will be fined 100,000 yuan
.
It can be seen that if a pharmacy sells TCM decoction pieces that do not meet the standards, as long as it meets the requirements of the "Opinions" and is deemed to "do not affect the safety and effectiveness", the fine of 100,000 yuan can be waived
.
.
The storage of Chinese herbal decoction pieces is a pain point for pharmacies
It is worth noting that the "Opinions", on the premise of "not meeting the drug standards", clarified the parameters of the safety and effectiveness of Chinese herbal decoction pieces
.
.
"Setting a range for the standard of Chinese medicine decoction pieces is a concrete manifestation of the progress of the industry
.
" Du Zhiyong , the person in charge of Rui Health, told Cyberland - pharmacy manager that Chinese medicine decoction pieces and Chinese medicine pursue a unified standard , which does not conform to the actual local situation
.
Taking the moisture and ash content of TCM decoction pieces as an example, the data of different origins of the same medicinal material are obviously different, and there will be differences in the usage of TCM in different regions
.
After the range is given, TCM can be more flexible and effective
.
.
" Du Zhiyong , the person in charge of Rui Health, told Cyberland - pharmacy manager that Chinese medicine decoction pieces and Chinese medicine pursue a unified standard , which does not conform to the actual local situation
.
Taking the moisture and ash content of TCM decoction pieces as an example, the data of different origins of the same medicinal material are obviously different, and there will be differences in the usage of TCM in different regions
.
After the range is given, TCM can be more flexible and effective
.
Du Zhiyong believes that if the regulation is promoted on a wider scale, it will actually be good for pharmacy operations
.
.
At present, the decoction pieces of traditional Chinese medicine sold by pharmacies are purchased from professional medicinal material companies.
The drugs and channels are generally legal and compliant, and there will be no major problems
.
On the contrary, the storage conditions of Chinese medicine decoction pieces are relatively high, and pharmacies are prone to violations if they are not careful
.
After the regulation is relaxed, the storage cost and the risk of non-compliance in pharmacies will be effectively reduced
.
The drugs and channels are generally legal and compliant, and there will be no major problems
.
On the contrary, the storage conditions of Chinese medicine decoction pieces are relatively high, and pharmacies are prone to violations if they are not careful
.
After the regulation is relaxed, the storage cost and the risk of non-compliance in pharmacies will be effectively reduced
.
For pharmacies, the reduction in the storage cost of Chinese herbal decoction pieces means that sales enthusiasm will increase
.
Yu Jie, a pharmacy researcher, said that many small and medium-sized pharmacies are reluctant to sell Chinese herbal decoction pieces, mostly because the conditions such as temperature and humidity are not up to standard
.
.
Yu Jie, a pharmacy researcher, said that many small and medium-sized pharmacies are reluctant to sell Chinese herbal decoction pieces, mostly because the conditions such as temperature and humidity are not up to standard
.
3 kinds of moisture content are related to the safety of traditional Chinese medicine pieces
In addition to Jiangsu, Guangdong has also issued relevant standards to determine the safety and effectiveness of Chinese herbal decoction pieces that "do not meet the drug standards"
.
.
On August 1, 2021, the Guangdong Food and Drug Administration's "Guidelines for the determination of Chinese herbal decoction pieces that do not meet drug standards and do not affect safety and effectiveness" were officially implemented
.
.
The relevant interpretation documents mentioned that the moisture content has an impact on the stability and physical and chemical properties of Chinese herbal decoction pieces, and controlling the moisture can prevent pests or mildew in the process of circulation and storage
.
.
The moisture limit in some TCM decoction pieces standards may not take into account the temperature and humidity differences in different regions of the country when the standards are formulated, and some TCM decoction pieces are more likely to exceed the water content in the warm and humid Guangdong Province
.
.
The Guangdong Food and Drug Administration stated in the document that when the moisture or weight loss on drying items of Chinese herbal medicines do not meet the regulations, whether it affects the safety and effectiveness of the drug, three situations are specifically considered:
1.
If it exceeds 20% (including 20%) of the limit specified in the standard, it can be regarded as not affecting the effectiveness and safety of Chinese herbal pieces
.
If it exceeds 20% (including 20%) of the limit specified in the standard, it can be regarded as not affecting the effectiveness and safety of Chinese herbal pieces
.
2.
If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
The mycotoxin inspection result is in compliance with the regulations, and it can be regarded as not affecting the effectiveness and safety of Chinese herbal decoction pieces.
The mycotoxin inspection result is: Those that do not comply with the regulations can be considered as affecting the safety of Chinese herbal pieces
.
If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
The mycotoxin inspection result is in compliance with the regulations, and it can be regarded as not affecting the effectiveness and safety of Chinese herbal decoction pieces.
The mycotoxin inspection result is: Those that do not comply with the regulations can be considered as affecting the safety of Chinese herbal pieces
.
3.
If it exceeds 30% of the limit specified in the standard, it can be considered as affecting the safety or effectiveness of Chinese herbal decoction pieces
.
If it exceeds 30% of the limit specified in the standard, it can be considered as affecting the safety or effectiveness of Chinese herbal decoction pieces
.
According to incomplete statistics, Jiangsu, Guangdong, Shandong, Anhui and other provinces have issued relevant documents to clarify the safety and effectiveness standards for Chinese herbal decoction pieces that "do not meet the drug standards"
.
.
The policy of Chinese herbal medicine in one place is relaxed, and pharmacies can be exempted from fines of 100,000
.
.
The policy of Chinese herbal decoction pieces is relaxed, and pharmacies can be exempted from fines of 100,000
The policy of Chinese herbal decoction pieces is relaxed, and pharmacies can be exempted from fines of 100,000 A few days ago, the Jiangsu Food and Drug Administration issued the "Guiding Opinions on the Determination of Jiangsu Province Traditional Chinese Medicine Pieces Do Not Comply with Drug Standards and Does Not Affect Safety and Effectiveness (Trial)" (hereinafter referred to as "Opinions")
.
medicines medicines medicines.
The "Opinions" stated that the determination of whether the TCM decoction pieces that do not meet the drug standards "does not affect the safety and effectiveness" does not change the conclusion that "does not meet the drug standards (determined as inferior drugs)"
.
.
In addition, the "Opinions" provide a variety of situations for the properties, moisture, ash, and impurities of TCM decoction pieces that do not meet the standard requirements, so as to determine that the safety and effectiveness of TCM decoction pieces have not been affected
.
Details are as follows:
.
Details are as follows:
1.
Character item
1. Character item
Character item
2.
Moisture
2. Moisture
Moisture
3.
Ash
3. Ash
Ash
4.
Impurities
4. Impurities
Impurities
The "Opinions" also mentioned that in the investigation and handling of cases, drug supervision and administration departments at all levels should, in accordance with this Opinion, combined with the specific circumstances of non-compliance with drug standards and the relevant illegal facts identified, determine whether the "safety and effectiveness" are affected.
"Make a comprehensive judgment
.
"Make a comprehensive judgment
.
If it is still difficult to identify a special variety based on this opinion, or if the parties have objections to the identification result, the relevant personnel may organize expert discussions and put forward technical opinions on the determination
.
.
According to the relevant provisions of the "Drug Administration Law", if the production or sale of Chinese herbal decoction pieces does not meet the drug standards and does not affect the safety and effectiveness, it shall be ordered to make corrections within a time limit and given a warning; a fine of not less than 100,000 yuan but not more than 500,000 yuan may be imposed.
.
In addition, those who produce and sell inferior medicines will be fined 100,000 yuan
.
.
In addition, those who produce and sell inferior medicines will be fined 100,000 yuan
.
It can be seen that if a pharmacy sells TCM decoction pieces that do not meet the standards, as long as it meets the requirements of the "Opinions" and is deemed to "do not affect the safety and effectiveness", the fine of 100,000 yuan can be waived
.
pharmacy pharmacy pharmacy.
The storage of Chinese herbal decoction pieces is a pain point for pharmacies
The storage of Chinese herbal decoction pieces is a pain point for pharmacies It is worth noting that the "Opinions", on the premise of "not meeting the drug standards", clarified the parameters of the safety and effectiveness of Chinese herbal decoction pieces
.
.
"Setting a range for the standard of Chinese medicine decoction pieces is a concrete manifestation of the progress of the industry
.
" Du Zhiyong , the person in charge of Rui Health, told Cyberland - pharmacy manager that Chinese medicine decoction pieces and Chinese medicine pursue a unified standard , which does not conform to the actual local situation
.
Taking the moisture and ash content of TCM decoction pieces as an example, the data of different origins of the same medicinal material are obviously different, and there will be differences in the usage of TCM in different regions
.
After the range is given, TCM can be more flexible and effective
.
health health standard standard standard medicinal material medicinal material medicinal material.
" Du Zhiyong , the person in charge of Rui Health, told Cyberland - pharmacy manager that Chinese medicine decoction pieces and Chinese medicine pursue a unified standard , which does not conform to the actual local situation
.
Taking the moisture and ash content of TCM decoction pieces as an example, the data of different origins of the same medicinal material are obviously different, and there will be differences in the usage of TCM in different regions
.
After the range is given, TCM can be more flexible and effective
.
Du Zhiyong believes that if the regulation is promoted on a wider scale, it will actually be good for pharmacy operations
.
.
At present, the decoction pieces of traditional Chinese medicine sold by pharmacies are purchased from professional medicinal material companies.
The drugs and channels are generally legal and compliant, and there will be no major problems
.
On the contrary, the storage conditions of Chinese medicine decoction pieces are relatively high, and pharmacies are prone to violations if they are not careful
.
After the regulation is relaxed, the storage cost and the risk of non-compliance in pharmacies will be effectively reduced
.
The drugs and channels are generally legal and compliant, and there will be no major problems
.
On the contrary, the storage conditions of Chinese medicine decoction pieces are relatively high, and pharmacies are prone to violations if they are not careful
.
After the regulation is relaxed, the storage cost and the risk of non-compliance in pharmacies will be effectively reduced
.
For pharmacies, the reduction in the storage cost of Chinese herbal decoction pieces means that sales enthusiasm will increase
.
Yu Jie, a pharmacy researcher, said that many small and medium-sized pharmacies are reluctant to sell Chinese herbal decoction pieces, mostly because the conditions such as temperature and humidity are not up to standard
.
.
Yu Jie, a pharmacy researcher, said that many small and medium-sized pharmacies are reluctant to sell Chinese herbal decoction pieces, mostly because the conditions such as temperature and humidity are not up to standard
.
3 kinds of moisture content are related to the safety of traditional Chinese medicine pieces
3 kinds of moisture content are related to the safety of traditional Chinese medicine pieces In addition to Jiangsu, Guangdong has also issued relevant standards to determine the safety and effectiveness of Chinese herbal decoction pieces that "do not meet the drug standards"
.
.
On August 1, 2021, the Guangdong Food and Drug Administration's "Guidelines for the determination of Chinese herbal decoction pieces that do not meet drug standards and do not affect safety and effectiveness" were officially implemented
.
.
The relevant interpretation documents mentioned that the moisture content has an impact on the stability and physical and chemical properties of Chinese herbal decoction pieces, and controlling the moisture can prevent pests or mildew in the process of circulation and storage
.
.
The moisture limit in some TCM decoction pieces standards may not take into account the temperature and humidity differences in different regions of the country when the standards are formulated, and some TCM decoction pieces are more likely to exceed the water content in the warm and humid Guangdong Province
.
.
The Guangdong Food and Drug Administration stated in the document that when the moisture or weight loss on drying items of Chinese herbal medicines do not meet the regulations, whether it affects the safety and effectiveness of the drug, three situations are specifically considered:
1.
If it exceeds 20% (including 20%) of the limit specified in the standard, it can be regarded as not affecting the effectiveness and safety of Chinese herbal pieces
.
If it exceeds 20% (including 20%) of the limit specified in the standard, it can be regarded as not affecting the effectiveness and safety of Chinese herbal pieces
.
2.
If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
The mycotoxin inspection result is in compliance with the regulations, and it can be regarded as not affecting the effectiveness and safety of Chinese herbal decoction pieces.
The mycotoxin inspection result is: Those that do not comply with the regulations can be considered as affecting the safety of Chinese herbal pieces
.
If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
The mycotoxin inspection result is in compliance with the regulations, and it can be regarded as not affecting the effectiveness and safety of Chinese herbal decoction pieces.
The mycotoxin inspection result is: Those that do not comply with the regulations can be considered as affecting the safety of Chinese herbal pieces
.
3.
If it exceeds 30% of the limit specified in the standard, it can be considered as affecting the safety or effectiveness of Chinese herbal decoction pieces
.
If it exceeds 30% of the limit specified in the standard, it can be considered as affecting the safety or effectiveness of Chinese herbal decoction pieces
.
According to incomplete statistics, Jiangsu, Guangdong, Shandong, Anhui and other provinces have issued relevant documents to clarify the safety and effectiveness standards for Chinese herbal decoction pieces that "do not meet the drug standards"
.
.
