Source: Original manuscript of People’s Daily Online
People’s Daily Online, Beijing, February 25 (Reporter Sun Hongli) According to the official website of the State Food and Drug Administration, in order to carry out the investigation and punishment of Chinese medicine decoction pieces according to law, the State Food and Drug Administration recently Notice on the issuance of the “Guiding Opinions on the Principles of Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People’s Republic of China” (hereinafter referred to as the “Guiding Opinions”), clarifying that the decoction pieces of traditional Chinese medicine to which this article applies are derived from plants of natural origin. , animals, and mineral medicinal materials are processed. This article does not apply to the traditional Chinese medicine formula granules and the relevant toxic Chinese medicine decoction pieces in the “Administrative Measures for Toxic Drugs for Medical Use”.
The relevant person in charge of the State Food and Drug Administration introduced that the decoction pieces in the “Chinese Pharmacopoeia” refer to the medicinal materials that can be directly used in the clinical or preparation production of traditional Chinese medicine after processing. Most of Chinese herbal decoction pieces are derived from naturally grown Chinese herbal medicines, which are greatly affected by their growth environment, and may not meet the size, surface color and other items specified in the drug standards, but do not affect the safety and effectiveness.
The “Drug Administration Law” fully considers the particularity of Chinese herbal decoction pieces, and has made special provisions on its relevant legal responsibilities. Paragraph 2 of Article 117 stipulates: “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 and 500,000 yuan may be imposed. a fine of not more than $100.”
According to the “Guiding Opinions”, the premise of the application of this clause is that the source of Chinese herbal medicines used in the production of TCM decoction pieces (including the base, medicinal parts, processing at the place of origin, etc.), the processing technology of the decoction pieces, etc. It is limited to the following situations in the seventh item of paragraph 3 of Article 98 of the “Drug Administration Law” “other drugs that do not meet the drug standards”: properties such as size, surface color, etc. do not meet the drug standards; inspection items such as moisture, Ash, drug dust impurities, etc. do not meet the drug standards. Among them, when the inspection items do not meet the standards, other indicators that do not meet the standards shall be excluded.
The application of this clause does not change the nature of Chinese herbal decoction pieces not meeting the drug standards. Production and operation enterprises shall recall non-standard decoction pieces in accordance with relevant regulations, find and analyze the reasons, conduct safety risk assessment on them, and deal with them according to the assessment results.
The “Guiding Opinions” pointed out that when applying this clause, it should be strictly in accordance with the “Administrative Punishment Law” and the “Regulations on the Implementation of the Drug Administration Law” on the application of lighter, less severe and no administrative penalties. The specific case, quality risks, etc. shall comprehensively decide on the punishment measures, reflecting the principle of excessive punishment.