Generic drugs are an important component of the drug supply guarantee system. The reporter learned from the National Health Commission that the National Health Commission, in conjunction with the Ministry of Industry and Information Technology, the China National Intellectual Property Administration, the National Health Insurance Bureau, the National Bureau of Disease Control and Prevention, the State Food and Drug Administration and other departments, has recently organized experts to select and demonstrate the drugs whose domestic patents are about to expire and whose clinical supply is in short supply (insufficient competition), and formulated the Third Batch of Drugs Encouraged to Copy. The third batch of catalogs includes 39 varieties, involving 75 product specifications and 13 dosage forms, covering 12 therapeutic drugs such as anti-tumor drugs and immunomodulators, anti infective drugs, neurological drugs, radiation diagnostic agents, and cardiovascular system drugs. It is reported that the third batch of catalogs is guided by clinical drug demand. One is to fill the gap in clinical medication in China. The third batch of catalogs includes multiple drugs that have been listed overseas but have not been listed domestically. For example, small interfering RNA drugs such as Patislam are used to treat adult hereditary amyloidosis mediated by thyroxine, and oral drugs such as Cyclosporine are used in combination with immunosuppressants to treat active lupus nephritis in adults. The second is to improve the accessibility of drugs. Some of the drugs included in the third batch of catalogs, although drugs with the same mechanism of action have already been listed in China, are also included in the scope of encouraging imitation due to the high clinical demand and the risk of supply shortage. The third is to encourage innovative formulation technologies. The third batch of catalog includes not only traditional tablets and capsules, but also new drug formulations such as sustained-release injections, dry suspensions, sublingual tablets, as well as suitable dosage forms for children and new compound formulations. The fourth is to improve the accuracy of clinical diagnosis. The third batch of catalogs includes 6 radioactive drugs that can be used for imaging diagnosis and localization, all of which are domestically unlisted drugs. The reporter learned that previously, the National Health Commission, in conjunction with relevant departments, has released two batches of the "Catalogue of Encouraged Imitation Drugs", which has effectively encouraged and guided the research and marketing of drugs listed in the catalogue. At present, 33 varieties in the catalog have been approved for marketing, covering 15 therapeutic drugs such as anti infective drugs, anti-tumor drugs and immune modulators, nervous system drugs, etc., including 7 rare disease drugs. The National Health Commission stated that it will timely organize relevant units, industry associations, and interested business entities to strengthen multi-party policy communication, technical consultation, and work coordination, and better support and guide enterprises in the research and development, registration, and production of high-quality generic drugs for clinical needs. (Reporter Li Heng) (Liao Xinshe)
Edit：GuoGuo Responsible editor：FangZhiYou
Source：news.cn
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