Strictly enforce the processing standards of decoction pieces and the pilot research and management of formula granules

Recently, the State Food and Drug Administration issued a notice requiring all provincial food and drug administrations to strictly regulate the processing of Chinese herbal pieces and the pilot research and management of Chinese herbal formula particles It is understood that in view of the problems such as including the scientific research products in the scientific research stage or the products managed according to the preparation into the processing specifications, the notice requires that when the provincial food and drug regulatory departments formulate or revise the processing specifications of Chinese Herbal Pieces in their respective jurisdictions, they should strictly follow the relevant provisions of the drug management law and its implementation regulations, and the scope of their collection is limited to the local processing characteristics and the use of Chinese medicine Characteristic processing methods and Chinese herbal pieces; scientific research products which are still in the stage of scientific research and have not obtained the recognized safety and effectiveness data, as well as tablets, granules and other conventional products under preparation management shall not be used as Chinese Herbal Pieces management, and the processing specifications of Chinese herbal pieces shall not be formulated for them The circular pointed out that the traditional Chinese medicine formula granules are still in the pilot study of scientific research, and the State Administration will promote the pilot study of traditional Chinese medicine formula granules with relevant departments, find problems, summarize experience and timely issue relevant regulations Before that, the provincial food and drug regulatory authorities shall not approve the production of traditional Chinese medicine formula granules in any name According to the notice, each provincial food and drug regulatory department shall, in strict accordance with the procedures and requirements specified in the measures for the administration of drug registration and other rules or documents, handle the drug registration approval or filing matters in the charge of the food and drug regulatory department Administration according to law, strict standards and strict examination and approval The improper examination and approval behaviors that have occurred must be corrected and properly handled immediately The State Administration will carry out supervision and inspection Once problems are found, they will be seriously investigated and punished according to laws and regulations, and the relevant responsible persons will be held accountable.