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    Home > Active Ingredient News > Drugs Articles > Extract has become the "target" of regulatory authorities, which has dragged down the traditional Chinese medicine industry

    Extract has become the "target" of regulatory authorities, which has dragged down the traditional Chinese medicine industry

    • Last Update: 2017-08-09
    • Source: Internet
    • Author: User
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    [industry trends of China Pharmaceutical network] recently, the State Food and Drug Administration issued a notice, requiring all relevant enterprises of Chinese herbal extract production and use to carry out self inspection this month, and the provincial food and Drug Administration intervened in the special inspection in September, which means that the State Food and drug administration has to fight hard to rectify the industry's "weakness" (the extract has become the "target" of the regulatory authorities, dragging down the traditional Chinese medicine industry Photo source: Baidu photo) the extract has dragged down the traditional Chinese medicine industry In yesterday's announcement, the State Food and Drug Administration said that from the recent inspection, there are still some enterprises dare to commit crimes against the wind, producing and purchasing and using traditional Chinese medicine extracts in violation of regulations, which brings safety risks to the quality of traditional Chinese medicine "In fact, traditional Chinese medicine extract is a commonplace topic, which is a major" weakness "of traditional Chinese medicine industry In addition to the previous wave of Ginkgo biloba extract, it is estimated that the special treatment will cover a wide range and last for a long time." An industry observer told reporters   The relevant directors of the State Food and drug administration have previously publicly pointed out several crimes of Chinese herbal extracts dragging the "hind legs" of the traditional Chinese medicine industry: some Chinese patent medicine enterprises do not have the ability to extract, and it is difficult to guarantee the quality of drugs produced by purchasing illegal extracts; the relevant management system is not perfect and there are many loopholes; the existing drug regulatory laws and regulations do not clearly define the regulatory attributes of Chinese herbal extracts, Chinese herbal extracts The situation of production and use is not clear, which is separated from the drug quality supervision system Under such a strict "one size fits all" policy, the Ginkgo biloba extract storm happened again In 2015, the State Food and Drug Administration issued the notice on illegal production and sale of Ginkgo biloba drugs by Guilin Xingda Pharmaceutical Co., Ltd and other enterprises It was found that 24 pharmaceutical enterprises had the problem of purchasing illegal Ginkgo biloba extract, and some enterprises had the behavior of changing process to illegally produce Ginkgo biloba extract Then the State Food and Drug Administration issued the investigation and handling results, which showed that 59 enterprises were punished according to law for producing fake drugs and substandard drugs, including 4 enterprises whose "drug production license" was revoked; 47 enterprises were fined and other administrative penalties, with a total amount of 103 million yuan of fines; 4 enterprises were shut down without drug production qualification However, there are still risks and violations Yesterday, the reporter combed out the four key inspection points of the new notice of the State Food and Drug Administration: 1 Key inspection of Chinese herbal extract production enterprises: the record of extract production; Organize the production according to the GMP requirements; check whether there is the OEM production behavior of the purchased traditional Chinese medicine extracts; 2 Key inspection of the traditional Chinese medicine manufacturers: the use and filing of the extracts; the quality evaluation of the extracts and the audit of the suppliers; whether there is material balance in the production process; whether there is the use of illegal extracts; 3 Set up the extraction vehicles in common and in different places within the group The key inspection of pharmaceutical manufacturing enterprises among: the production and quality management of extracts; the adequacy of quality control measures in the storage, packaging, transportation and other aspects of extracts; 4 Whether the enterprises and varieties that have been put on record meet the requirements of this document, and whether the records that do not meet the requirements are handled.
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