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    Home > Active Ingredient News > Drugs Articles > The State Food and drug administration strengthens the supervision of the extraction of traditional Chinese medicine and orders the unqualified pharmaceutical enterprises to stop production

    The State Food and drug administration strengthens the supervision of the extraction of traditional Chinese medicine and orders the unqualified pharmaceutical enterprises to stop production

    • Last Update: 2016-01-04
    • Source: Internet
    • Author: User
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    Source: zhongxin.com.cn, January 4, 2016, China news.cn, December 31, according to the website of the State Food and drug administration, in view of the outstanding problems in the extraction process 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 (SFDA [2014] 135) in July 2014 No., hereinafter referred to as document No 135), which specifies the requirements for extraction and extraction management of traditional Chinese medicine and specifies the transition period From January 1, 2016, any Chinese patent medicine manufacturing enterprise that does not have the corresponding extraction capacity must stop production, and the production and use of Chinese herbal extracts must be recorded From January 1, 2016, any Chinese patent medicine manufacturer that does not have the corresponding extraction capacity must stop production The food and Drug Administration of each province (district or city) shall stop approving the extraction and processing of traditional Chinese medicine according to the requirements of Document No 135 For the approved entrusted processing of extraction of traditional Chinese medicine, pharmaceutical manufacturers are required to stop the entrusted extraction from January 1, 2016 For the Chinese patent medicine manufacturers without the ability of pretreatment and extraction of traditional Chinese medicine, the production of corresponding traditional Chinese medicine varieties will be stopped from January 1, 2016 If the production is not stopped within the time limit, the food and drug administration shall seriously investigate and deal with it in accordance with Article 78 of the drug administration law of the people's Republic of China (revised in 2015, the same below) Since January 1, 2016, the production and use of Chinese herbal extracts must be recorded As of January 1, 2016, the Chinese patent medicine national drug standard prescription items were downloaded, and the Chinese herbal extracts with separate national drug standards were 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 (see the annex to document No 135) All those who violate the regulations and use the undocumented traditional Chinese medicine extracts to produce Chinese patent medicines shall be seriously investigated and punished by the food and Drug Administration of each province (District, city) in accordance with the provisions of Article 78 of the drug administration law of the people's Republic of China The food and Drug Administration of each province (district or city) shall, in accordance with the requirements of Article 7 of document 135 and Article 2 of its annex, strictly examine the scope of the Chinese herbal extracts for filing, and shall not file those that are not within the scope of filing; those that have been filed must be cancelled Strengthen supervision and inspection The food and Drug Administration of each province (district or city) shall strengthen the supervision and inspection, implement the supervision responsibility, and ensure that the above-mentioned enterprises should stop production on time We should resolutely investigate and deal with the illegal behaviors found in the inspection according to law and make them public in time The pharmaceutical production license (or the corresponding scope of production) shall not be renewed for any Chinese patent medicine manufacturing enterprise that does not have the ability to extract traditional Chinese medicine; the pharmaceutical production license shall not be issued for any enterprise that produces traditional Chinese medicine extract alone The State Food and Drug Administration will further increase the intensity and frequency of flight inspection and follow-up inspection, seriously investigate, punish and expose illegal production activities, and criticize and seriously hold accountable the places that are not strictly controlled and poorly supervised.
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