Production and use of Chinese herbal extracts must be recorded

Since 2016, the production and use of traditional Chinese medicine extracts must be put on record, and enterprises without record will be punished The production and use of traditional Chinese medicine extracts must be recorded Recently, the State Food and Drug Administration issued a notice requiring that, starting from January 1, 2016, any proprietary Chinese medicine that does not have the ability of pretreatment and extraction of traditional Chinese Medicine Production enterprises shall stop the production of corresponding traditional Chinese medicine varieties If they do not stop production within the time limit, they shall be investigated and punished in accordance with the drug administration law Meanwhile, the production and use of traditional Chinese medicine extracts must be put on record The extraction process and extract of traditional Chinese medicine are the premise and foundation to ensure the quality of traditional Chinese medicine is controllable, safe and effective In recent years, the problems in the extraction or outsourcing of traditional Chinese medicine extracts are quite prominent In 2015, the widespread violations of Ginkgo biloba drugs were caused by the illegal changes of Ginkgo biloba extraction process and the illegal production of extracts by relevant enterprises, which caused major hidden dangers to the quality and safety of drugs Since July 2014, China has completely stopped the examination and approval of the entrusted processing of Chinese medicine extraction, and the approved one will continue to December 31, 2015 The General Administration of food and drug of the people's Republic of China has made it clear that, since January 1 this year, the entrusted extraction of traditional Chinese medicine pharmaceutical manufacturers will be completely stopped, and those enterprises that do not have the ability to extract must stop the production of corresponding varieties, and shall not renew the pharmaceutical production license; and those enterprises that independently produce traditional Chinese medicine extracts shall not re issue the pharmaceutical production license The State Administration of food and drug pointed out that for the Chinese patent medicine with the national drug standard prescription items downloaded clearly and the Chinese herbal extracts with the independent national drug standard implemented the filing management Any enterprise that produces or uses the above Chinese herbal extracts must be filed with the provincial food and drug administration; each place should strictly review the scope of the filing of Chinese herbal extracts, and those that do not belong to the scope of the filing will not be filed Those recorded must be cancelled.