The State Food and Drug Administration approved the listing of three innovative traditional Chinese medicine drugs. This year is the most one year that new traditional Chinese medicine drugs have been approved in the past five years

2021-11-29

According to the official website of the State Food and drug administration, recently, the State Drug Administration approved the listing registration application of three innovative traditional Chinese medicine drugs: xuanqijiangu tablets, Qizhi Yishen capsules and kunxinning granules. Among them, Xuanqi Jiangu tablet can be used in the treatment of mild to moderate knee osteoarthritis, which belongs to muscle and pulse stasis syndrome. The clinical trial results of Qi Zhi Yi Shen capsule showed that it could be used for the treatment of early diabetic nephropathy with deficiency of Qi and Yin. The clinical trial results of kunxinning granule show that it can be used for the treatment of Chinese medicine syndrome differentiation of female climacteric syndrome, which belongs to the deficiency of kidney yin and Yang. The State Food and Drug Administration said that the above three innovative traditional Chinese medicine drugs were developed based on the clinical experience of traditional Chinese medicine. The evidence of safety and effectiveness was obtained through randomized, double-blind, placebo-controlled and multicenter clinical trials. After being approved for listing, they will provide new treatment options for patients with clinically related diseases. It is reported that the State Food and drug administration has paid attention to highlighting the characteristics of traditional Chinese medicine and encouraging the inheritance and innovation of traditional Chinese medicine in the preparation and revision of regulations and documents such as the measures for the administration of drug registration and the requirements for registration classification and application materials of traditional Chinese medicine. According to the product characteristics, innovation degree and review management needs of registered drugs of traditional Chinese medicine, guided by clinical value, respecting the law of traditional Chinese medicine research and development, the classification of traditional Chinese medicine has been optimized according to laws and regulations, the material basis is no longer used as the basis for dividing the registration categories, and the chemical component content requirements of "effective components" and "effective parts" in the "original measures" have been weakened, The registration of traditional Chinese medicine is classified according to innovative traditional Chinese medicine, improved new traditional Chinese medicine, traditional Chinese medicine compound preparations of ancient classic famous prescriptions, drugs with the same name and the same prescription, etc. The new registration classification of traditional Chinese medicine is guided by clinical value, respects the law of traditional Chinese medicine research and development, encourages the inheritance and innovation of traditional Chinese medicine, releases the innovation potential of traditional Chinese medicine to the greatest extent, and fully reflects the characteristics of traditional Chinese medicine. The State Food and Drug Administration said that up to now, in 2021, on the basis of emergency approval of Qingfei Paidu granules, Huashi Baidu granules and Xuanfei Baidu granules, the State Food and drug administration has approved the listing of six new traditional Chinese medicine drugs, which has become the year with the largest number of new traditional Chinese medicine drugs approved in recent five years. The reform of the review and approval system of traditional Chinese medicine has achieved initial results. (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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