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A brief discussion on the necessity of differentiated management of the validity label of TCM decoction pieces

 The newly revised "Drug Administration Law" (hereinafter referred to as the new law) has been implemented for more than a year, in the daily supervision of drugs, the author found that some of the labels of traditional Chinese medicine slices supplied by the market are not marked with "expiration date", which is out of step with the requirements of the new law。The author suggests that the drug regulatory authorities as soon as possible to issue relevant provisions on the validity of TCM decoction pieces, in order to achieve an effective connection with the new law。

Legal evolution "period of validity" annotation provisions have changed
In 1984, China's first Drug Administration Law was promulgated, and drug supervision gradually embarked on the track of legalization。Article 34 of the Law stipulates that drugs "beyond the expiry date" are substandard drugs。At that time, only antibiotics, biological products, enzyme preparations, blood products and other unstable drugs were marked with "expiration date" or "expiration period", and most drugs (including Chinese medicine) did not need to be marked。As long as there is no abnormal change in the appearance of the drug, it can be used continuously。
The Drug Administration Law was amended for the first time in 2001。After the revision of Article 49 of the Law, in addition to stipulating that "drugs beyond the expiration date" are classified as inferior drugs, it also adds the provision that "drugs without indicating the expiration date or changing the expiration date" are classified as inferior drugs。This means that all drugs must be marked with an "expiration date", otherwise they will be punished as inferior drugs。In 2002, the Implementation Regulations of the Drug Administration Law (hereinafter referred to as the Implementation Regulations) were promulgated and implemented。The second paragraph of Article 45 of the Regulations stipulates that "the label of Chinese medicine prepared pieces must indicate the name of the product, specifications, origin, production enterprise, product batch number, production date, and the drug approval number of Chinese medicine prepared pieces implemented the approval number management must also indicate the drug approval number."。2003年,The State Drug Administration issued the Notice on Issuing Supplementary Provisions on TCM Decoction Pieces and Medical Oxygen GMP,The notice is attached to the requirements of Article 24 of the Supplementary Provisions on GMP for Chinese Herbal Decoction Pieces,Labels must be printed or affixed to the packages of prepared pieces of Chinese medicine,Indicate the name of the product, specifications, origin, production enterprise, product batch number, production date。The "Notice on Strengthening the Supervision and Management of the Packaging of Chinese herbal Medicine Pieces" issued in the same year also requires that "the labels of Chinese herbal medicine pieces indicate the name of the product, specifications, origin, production enterprise, product batch number, and production date."。The 2002 version of the Implementing Regulations and the above two notices did not include the "validity period" in the packaging label of TCM decoction pieces according to the relevant requirements of the 2001 version of the Drug Administration Law。Subsequently, the "Implementation Regulations" underwent two amendments in 2016 and 2019, respectively, but the relevant contents on the validity period of traditional Chinese medicine pieces were not amended。The reason may be that TCM decoction pieces have their particularity, after all, TCM has "six Chen"。
In 2019, the Drug Administration Law was revised for the second time。Article 98 of the new law stipulates that "drugs whose validity period is not marked or changed" and "drugs that exceed the validity period" are substandard drugs。This means that "drugs with unmarked or altered expiration dates" can be directly characterized as inferior drugs, rather than being treated as inferior drugs。
The label of "validity period" in the decoction slice market is out of line with the new law requirements
Before 1985, there were no regulations governing drug management。The 1963 edition of "Chinese Pharmacopoeia" for the first time listed Chinese medicinal materials and Chinese medicinal preparations in a single pharmacopoeia, Chinese medicinal pieces are basically processed, operated and used under the guidance of traditional Chinese medicine theory。At that time, almost all street pharmacies were "front shop after factory" mode, the traditional Chinese medicine slices were complex, the processing quality was uneven, and the local traditional medicinal materials were widely used, and the differences between different places were very great。
From 1985 to 2001, although the 1984 version of the Drug Administration Law regulated drug management, the management of TCM decoction pieces was still relatively lax。The wholesale company may also know the specifications of the origin when buying Chinese medicine decoction pieces because of the large package is complete, but there is no mark on the production date。If medical institutions or retail enterprises need to disassemble when purchasing, they can use woven bags, cloth bags or plastic bags, and then use strips to indicate the name of the pieces into the bag。
From 2001 to 2019, according to the provisions of the 2001 version of the Drug Administration Law, all chemical drugs and proprietary Chinese medicines have been marked with "expiration date" or "shelf life" on the label.。With the implementation of GAP and GMP, the production of TCM decoction pieces has gradually changed from civilian processing to enterprise production, and bulk TCM decoction pieces have gradually been replaced by quantitative packaging, and some TCM decoction pieces have also applied for drug approval numbers, but TCM decoction pieces have not been marked with "expiration date".。
After the implementation of the new law in 2019, the traditional Chinese medicine pieces purchased by medical institutions or drug retail enterprises have quantitative packaging, affixed or printed labels, but only some pieces are marked with "expiration date", and most of the labels are still not marked with "expiration date", which is out of line with the requirements of the new law。The implementation standard of decoction pieces is the "Chinese Pharmacopoeia", but the label is marked with "shelf life" or "storage period", which is inconsistent with the "validity period" required by the new law。
The legislative proposal is to develop a catalogue of varieties that do not need to be marked with expiration dates
As for the validity period of drugs, the previous version of the Drug Administration Law does not make an exception for traditional Chinese medicine decoction pieces。Therefore, the author suggests that when amending the "Implementation Regulations", the "validity period" should be included in the contents of the packaging label of Chinese herbal medicine pieces。
There is no "drug validity period" or "use period" in the theory of traditional Chinese medicine, on the contrary, Chinese medicine has "six Chen", namely fructus aurantii, orange peel, pinellia, ephedra, wolfberry and Evodia "six kinds of medicine should be aged for a long time" "one hundred years of orange peel gold"。At present, the expiration date of domestic listed drugs is generally not more than 5 years, and orange peel and other decoction pieces are generally not marked because of the "six Chen" argument。But according to the new law, "century-old tangerine peel" is a bad medicine。There are also some fossil mineral Chinese medicine properties are very stable, no change for many years, if more than 5 years to discard, easy to cause a waste of resources。At the same time, some toxic Chinese medicine (such as arsenic, realgar, light powder, etc.) even if harmless treatment, its harmful substances (especially heavy metals, arsenic and other substances) can not be lost, causing pollution to the natural environment。
Before June 1, 2014,The licensing system shall be implemented for the distribution of Category II medical devices,However, the State drug administration issued the first and second batches of the "Second Category of medical Device Products that do not need to apply for the Medical Device Distribution Enterprise License" in 2005 and 2011 respectively.,So that some commonly used type II medical devices can be operated without a license,It has provided great convenience for the masses to use weapons。For TCM decoction pieces, can you also try to follow this method?
The author suggests,The State drug regulatory department may formulate and publish a catalogue of varieties of TCM prepared pieces without marking the validity period,The "six Chen" Chinese medicine and some very stable Chinese medicine are included in it,So that this part of Chinese medicine does not need to be marked with "expiration date",It won't be considered a bad drug by law,At the same time, it is required that other TCM decoction pieces should be marked with "expiration date" according to law.,In order to realize the effective connection between TCM decoction pieces and the new law。In addition, in line with the new law, labeling methods such as "expiration date", "use period", "use end date", "shelf life", "storage period" and "responsible period" should be prohibited on drug labels, and only "expiration date" should be used。
Author's point of view, for learning exchange

Wen | Liu Junrong
Source: | China Medical News

(2021/7/5 10:32:37 Read 7095 times)

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