According to the information on the official website of the State Food and drug administration, in order to carry out the investigation and handling of the cases of Chinese herbal slices according to law, the State Food and Drug Administration recently issued the notice on the guiding opinions on the application principles 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), which makes it clear that the Chinese herbal slices applicable to this article are processed from plants, animals and minerals of natural origin. This clause is not applicable to the Chinese medicine formula granules and the relevant toxic Chinese medicine Pieces in the administrative measures for toxic drugs for medical use. According to the relevant person in charge of the State Food and drug administration, the prepared slices in the Chinese Pharmacopoeia refer to the drugs that can be directly used in the clinical practice of traditional Chinese medicine or the production of preparations after processing. Most of Chinese herbal slices are from natural 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 not affect the safety and effectiveness. The drug administration law fully takes into account the particularity of Chinese herbal slices and makes special provisions on their relevant legal responsibilities. The second paragraph of Article 117 stipulates that "if the prepared slices of traditional Chinese medicine produced or sold do not meet the drug standards and do not affect the safety and effectiveness, they shall be ordered to make corrections within a time limit and given a warning; and may be fined not less than 100000 yuan but not more than 500000 yuan". According to the guiding opinions, the premise of applying this article is that the source of Chinese herbal medicines used in the production of Chinese herbal pieces (including the original ingredients, medicinal parts, processing in the place of origin, etc.) and the processing technology of Chinese Herbal Pieces meet the requirements, and are only limited to the following circumstances of "other drugs that do not meet the drug standards" in Item 7, paragraph 3, Article 98 of the Drug Administration Law: the size and surface color of the character items do not meet the drug standards; The inspection items such as moisture, ash, drug debris and impurities do not meet the drug standards. Among them, if the inspection items do not meet the standards, the situation that other indicators do not meet the standards shall be excluded. The application of this article does not change the nature of Chinese herbal slices not meeting the drug standards. The production and business operation enterprises shall, in accordance with the relevant provisions, recall the non-conforming pieces, find out and analyze the reasons, conduct safety risk assessment on them, and deal with them according to the assessment results. The guiding opinions point out that when applying this article, the punishment measures shall be comprehensively judged in strict accordance with the relevant provisions of the administrative punishment law and the regulations for the implementation of the drug administration law on the application of lighter, mitigated and no administrative punishment, in combination with the specific circumstances of the case and the quality risk, so as to reflect the principle of equal punishment. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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