Traditional Chinese medicine innovation, and then welcome heavy benefits!

In recent years, in order to encourage the innovation of traditional Chinese medicine and promote the development of traditional Chinese medicine, the state has issued a series of policies and measures
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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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With the support of a series of favorable policies, both the number of applications and the number of approvals for innovative Chinese medicines in China have grown significantly
.
From 2018 to 2021, the number of new TCM drugs applied for clinical trials is 2, 0, 9 and 30 respectively
.
During the same period, the number of Chinese medicines approved were: 2, 2, 4 and 12 respectively
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Among them, the number of new TCM drugs approved in 2021 accounted for 54% of the total number of new TCM drugs approved in the past five years
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In addition, from the perspective of medical insurance support, the three new traditional Chinese medicine drugs approved in 2020, namely Jingu Pain Relief Gel, Lianhua Qingke Tablets, and Mulberry 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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Recently, the innovation of traditional Chinese medicine has received another major piece of good news
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In a proposal, industry insiders suggested that the horizontal linkage of departments should be strengthened, and an effective mechanism for science and technology, medical, traditional Chinese medicine and other departments to recommend qualified new traditional Chinese medicines to enter the fast-track review and approval channel should be established
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Previously, there were some voices in the industry reflecting the low efficiency of new drug review and registration of traditional Chinese medicines
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According to the data released by the Drug Evaluation Center of the State Food and Drug Administration, in the 10 years from 2010 to 2020, the number of applications for clinical research on new Chinese medicines was 514, and 252 were approved, but only 23 were successfully approved for marketing, and the approval rate was not high.
to 4.
5%
.
The low approval rate will not be conducive to stimulating the enthusiasm of traditional Chinese medicine enterprises for the development of new traditional Chinese medicines
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In response, the State Administration of Traditional Chinese Medicine stated in its reply that in terms of establishing a review and approval mechanism for new Chinese medicines, the State Food and Drug Administration is exploring the establishment of a horizontal linkage mechanism to accelerate the transformation of major national science and technology projects based on clinical needs
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At the same time, establish a research and development model of "clinical experience prescription - medical institution preparation - new traditional Chinese medicine", establish a diversified clinical efficacy evaluation system and technical guiding principle system of traditional Chinese medicine in line with the characteristics of traditional Chinese medicine, and encourage the innovation of traditional Chinese medicine
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The industry pointed out that the new "Measures for the Administration of Drug Registration" proposed to establish and improve the registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicines, adhere to the clinical value-oriented, and shift the focus of evaluation to the clinical efficacy and safety of new traditional Chinese medicines.
reach a consensus
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However, how to speed up the implementation of relevant regulations, there are still some bottlenecks to be solved
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In its reply, the State Food and Drug Administration stated that it would actively explore the establishment of a horizontal linkage mechanism and establish a research and development model of "clinical experience prescription - medical institution preparation - new traditional Chinese medicine".
After the implementation of these detailed measures, it will help to accelerate the speed of new drugs entering the hospital, and at the same time Stimulate the enthusiasm of enterprises to actively participate in the research and development of new drugs
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According to the forecast of Huaan Securities, the approval and listing of new Chinese medicines will be accelerated in the future, and the number of listings may exceed 20 each year
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Southwest Securities also pointed out that the policy encourages the innovative traditional Chinese medicine sector.
Under the background of standardized review and approval, the number of innovative traditional Chinese medicines on the market has grown steadily
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The agency believes that from the perspective of the number of applications, this trend will continue in the future, and the long-term growth of innovative traditional Chinese medicine drugs can be expected.
It is recommended to actively pay attention to innovative traditional Chinese medicine drug companies
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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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