According to the official website of the State Food and drug administration, in order to further improve the label management of Chinese herbal pieces, the State Food and Drug Administration recently solicited public opinions on the "Regulations on the management of packaging labels of Chinese herbal pieces (Draft for comments)" (hereinafter referred to as the "draft for comments") and its supporting technical documents. The deadline for consultation is August 4, 2022. The relevant person in charge of the State Food and Drug Administration said that the packaging label of Chinese herbal pieces is closely related to the quality and safety of Chinese herbal pieces, and is one of the elements to ensure the production, circulation and use safety of Chinese herbal pieces. At present, there are various forms of packaging labels for Chinese herbal medicine Pieces in circulation in the market. Some varieties are difficult to distinguish the management attributes of products (medicinal materials and pieces, food and drugs, etc.) only by packaging labels, resulting in difficulties in grass-roots supervision and law enforcement. The exposure draft makes it clear that the use of traditional Chinese medicine prepared from substances that are both food and traditional Chinese medicine should be clearly distinguished from products with food attributes on their labels. The full text of the exposure draft is divided into 18 articles, mainly including the scope of application, general requirements, responsible parties, packaging requirements, label printing requirements, label content requirements, packaging label management in the process of shipping, additional items of labels, identification of special pieces of traditional Chinese medicine, punishment and other contents. The exposure draft encourages the use of new scientific and technological means in the labeling of Chinese herbal pieces to improve the traceability management level of Chinese herbal pieces and facilitate the query of key quality attribute information. With regard to the shelf life, the relevant person in charge of the State Food and Drug Administration said that determining the shelf life of Chinese herbal pieces can reflect the stability of the internal quality and the safe use period of Chinese herbal pieces. According to the provisions of the drug administration law, the expiration date must be indicated on the drug label. Considering the special circumstances of Chinese herbal pieces (fresh drugs, old drugs, mineral drugs, etc.), according to the general practice of current production enterprises, it is stipulated in the packaging label of Chinese herbal pieces that the warranty period should generally be marked. The exposure draft also made it clear that the functional indications indicated on the labels of prepared slices of traditional Chinese medicine should comply with the provisions of the national drug standards or provincial standards for the processing of prepared slices of traditional Chinese medicine. If it exceeds the prescribed scope, it belongs to the situation that "the indications or functions indicated by drugs exceed the prescribed scope" as stipulated in Item (6) of paragraph 2, Article 98 of the drug administration law of the people's Republic of China, and it shall be investigated and dealt with according to law. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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