Approval of traditional Chinese medicine extraction and entrusted processing stopped

Recently, the State Food and Drug Administration issued the notice on strengthening the supervision and administration of extraction and extract in the production of traditional Chinese medicine, which requires strengthening the supervision of extraction and extract in the production of traditional Chinese medicine According to the notice, from the date of printing and distributing, the food and Drug Administration of all provinces (regions and cities) shall stop the examination and approval of the entrusted processing of traditional Chinese medicine extraction, and the approved ones can continue to December 31, 2015 Since January 1, 2016, all Chinese patent drug manufacturers without the ability to extract traditional Chinese medicine will stop the production of corresponding varieties According to the notice, the extraction of traditional Chinese medicine is a key link in the production and quality management of Chinese patent medicine, and the production enterprise must have the extraction ability suitable for its production variety and scale Pharmaceutical manufacturers can set up pre-treatment and extraction workshops in different places, or share pre-treatment and extraction workshops with pharmaceutical manufacturers with holding relationships within the group If a Chinese patent medicine manufacturing enterprise needs to set up a pretreatment or extraction workshop in another place, it shall be approved by the food and Drug Administration of the province (District, city) where the enterprise is located The establishment of a workshop in a different place across provinces (regions and cities) shall also be examined and approved by the food and Drug Administration of the province (region and city) where the workshop is located, and the production address of the workshop in a different place shall be indicated on the drug production license of the Chinese patent medicine manufacturer The notice emphasizes that the pretreatment of traditional Chinese medicine is an important process in the production of traditional Chinese medicine The enterprises producing traditional Chinese medicine and the enterprises producing traditional Chinese medicine extracts shall have the facilities and equipment for the pretreatment of traditional Chinese medicine corresponding to the varieties they produce, formulate the corresponding pretreatment process procedures, and process the traditional Chinese medicine materials If the raw materials of Chinese herbal pieces are purchased for production, they must be purchased from the production and operation enterprise of Chinese herbal pieces with legal qualification.