New regulations for Chinese medicine decoction pieces: pharmacies can be exempted from fines of 100,000

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

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The "Opinions" also mentioned that in the investigation and handling of cases, the 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.

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 traditional Chinese medicine 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.

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 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.

For pharmacies, the reduction in the storage cost of Chinese herbal decoction pieces means that sales enthusiasm will increase
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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
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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"
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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
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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
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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
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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:

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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
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If it exceeds the standard limit by 20% to 30%, additional mycotoxin inspection is required.
If the mycotoxin inspection result is in compliance with the regulations, it can be considered as not affecting the effectiveness and safety of traditional Chinese medicine 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
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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
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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"
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