From January to February 2022, CDE will undertake a total of 220 new Chinese medicine registration applications, including 13 new medicines

In recent years, the registration applications of traditional Chinese medicines have performed positively.
Data shows that the number of applications for traditional Chinese medicines in 2021 will reach 1,371, a new high in the number of applications for traditional Chinese medicines in the past six years
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Entering 2022, the number of registration applications for traditional Chinese medicine is also growing
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According to incomplete statistics, in January 2022, CDE undertook a total of 128 new applications for registration of traditional Chinese medicines in terms of acceptance numbers, and in February CDE undertook a total of 92 new drug registration applications in terms of acceptance numbers
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From January to February, CDE has undertaken a total of 220 new Chinese medicine registration applications
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From January to February 2022, there are 13 new drug applications, 86 supplementary applications, 204 supplementary applications, 1 generic application, and 2 import applications
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In addition, judging from the application of Class 1 innovative drugs of traditional Chinese medicine, from January to February, a number of acceptance numbers of Class 1 innovative drugs of traditional Chinese medicine were accepted
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Among them, in January, a total of 5 Chinese medicine category 1 innovative drug acceptance numbers were awarded, namely Chaijin Jieyu Anshen Tablets from Hunan University of Traditional Chinese Medicine, Fucoidan Sulfate and Fucoidan Capsules from Weihai Shengsheng Pharmaceutical, Sinopharm Dezhong (Foshan) Taizishenyue Capsule of Pharmaceutical Industry, Pomegranate Flower Suppository of Xinjiang Uyghur Medical Research Institute; in February, a total of 3 Chinese medicine Category 1 innovative drug acceptance numbers were accepted, all of which were IND applications, including Kangyuan Pharmaceutical’s Zaobai Anshen Granules, a class 1 innovative drug of traditional Chinese medicine, Catalpol and Kaipu Tablets of Suzhou Yusen
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According to the industry, the research and development of Class 1 new traditional Chinese medicine is an important indicator to measure the innovation ability and industry level of the traditional Chinese medicine industry in a region
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Compared with the innovation of chemical and biological drugs, the innovation of traditional Chinese medicine is more challenging
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"Traditional Chinese medicine refers to the evaluation standards of western medicine.
From research and development to a series of tests, after the approval, a lot of pharmacology and toxicology research needs to be done
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In addition, the raw materials of traditional Chinese medicine may also be affected by geographical location and environment, and the quality cannot be guaranteed.
It brings a lot of uncertainty to the test results, so the research and development is very difficult
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" In order to speed up the transformation and upgrading of the traditional Chinese medicine industry, in recent years, policies have been blowing frequently, which has promoted the enthusiasm of traditional Chinese medicine enterprises to innovate.

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For example, the "Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" put forward guiding opinions on the inheritance and innovation of traditional Chinese medicine; "Several Policies and Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics" proposed to optimize the management of the review and approval of traditional Chinese medicines and improve the classification and registration of traditional Chinese medicines.
Management, including optimizing the review and approval of new Chinese medicines with human experience, etc.
; "Requirements for Registration Classification and Application Materials of Chinese Medicines" divides Chinese medicines into 4 categories, including innovative Chinese medicines, improved new Chinese medicines, ancient classic prescriptions, and the same name.
Same prescription
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In addition, medical insurance also supports the inclusion of new Chinese medicines.
For example, the three new Chinese medicines approved in 2020, such as Jingu Pain Relief Gel, Lianhua Qingke Tablets, and Sangzhi Total Alkaloid Tablets, were all included in the national medical insurance catalog after negotiation that year
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It can be seen that the medical insurance department supports the innovative Chinese medicine drugs
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With the support of frequent policies, domestic innovative Chinese medicine drugs have reached new highs in both the number of applications and the number of approvals
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From 2018 to 2021, the number of new TCM drugs applied for clinical trials is 2, 0, 9 and 30 respectively
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At the same time, the number of approved traditional Chinese medicines are: 2, 2, 4, and 12
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Among them, the number of new TCM drugs approved in 2021 is as high as 12, accounting for more than half of the total number of new TCM drugs approved in the past five years
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In general, China has entered a new stage of new drug research and development, and the field of innovative traditional Chinese medicine in China is expected to continue to achieve new breakthroughs in the future
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Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
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