Chinese herbal extracts were ordered to stop production from strict control of substandard Enterprises

From January 1, any Chinese patent medicine production enterprise that does not have the corresponding extraction capacity must stop production If it does not stop production within the time limit, the food and Drug Administration will conduct serious investigation and punishment, and publicize the results to the society On the last day of 2015, the State Food and Drug Administration issued a notice again, requiring relevant enterprises and local food and drug regulatory authorities to strictly implement the relevant provisions on the supervision and administration of extraction and extract of traditional Chinese medicine In 2015, a number of pharmaceutical companies illegally produced and sold Ginkgo biloba extract and preparations, which were severely punished by the State Food and drug administration, and caused a lot of trouble in the circle In view of the outstanding problems existing in the extraction of traditional Chinese medicine, the State Food and Drug Administration issued the notice on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine (sfjyhj [2014] No 135, hereinafter referred to as "No 135 document") as early as July 2014, which clarified the requirements for the management of extraction and extraction of traditional Chinese medicine and stipulated the transition period, and the real implementation time is January 1 this year Since January 1 this year, the production and use of Chinese herbal extracts must be put on record For the Chinese patent medicine, the prescription items of the national drug standard should be downloaded clearly, and the Chinese herbal extracts with separate national drug standard should be put on record All enterprises that produce or use the above-mentioned Chinese herbal extracts must file with the food and Drug Administration of each province (district or city) in accordance with the implementation rules for the filing management of Chinese herbal extracts The State Food and drug administration requires Chinese patent medicine manufacturers that do not have the corresponding extraction capacity to stop production on January 1 The food and Drug Administration of each province (District, city) is required to stop approving the extraction and entrusted processing of traditional Chinese medicine in accordance with the requirements of Document No 135 For the approved entrusted processing of Chinese medicine extraction, the pharmaceutical production enterprises are required to stop the entrusted extraction from January 1 For the Chinese patent medicine production enterprises that do not have the ability of pretreatment and extraction of traditional Chinese medicine, the production of corresponding varieties of traditional Chinese medicine shall be stopped from January 1 If the production is not stopped within the time limit, the food and drug administration department will give serious treatment in accordance with the provisions of the drug administration law of the people's Republic of China (revised in 2015), including warning, order to make corrections within a time limit, order to stop production and business for rectification, and impose a fine of more than 5000 yuan but less than 20000 yuan; if the circumstances are serious, the drug production license and drug trade will also be revoked License and the qualification of drug clinical trial institutions.