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For a long time, the traditional Chinese medicine industry has been facing great difficulty in innovation, and R&D generally faces the problems of unclear mechanism of action and unclear active ingredients
.
However, in recent years, with the acceleration of Chinese medicine registration and approval, Chinese medicine has ushered in innovative development, and the number of innovative Chinese medicines approved has continued to increase
.
According to statistics, as of December 16, 58 new TCM drug applications and registrations have been accepted in 2021 (accepted numbers, the same below), which is an increase of 114.
81% compared to 2020; both of which apply for clinical application or application for marketing.
There were 48 and 10 record highs respectively
.
Among them, category 1 innovative drugs accounted for 86.
21% of the total new TCM drugs, including 36 category 1.
1 new drugs, 10 category 1.
2 new drugs, and 4 category 1.
3 drugs
.
Analysis believes that the continuous increase in the number of innovative Chinese medicines approved is closely related to policy assistance
.
It is understood that in order to encourage innovation in traditional Chinese medicine, the country has issued a series of documents in recent years
.
For example, on August 27, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for the Pharmaceutical Research of Chinese Medicine Compound Preparations Managed in the Catalogue of Ancient Classical Prescriptions (for Trial Implementation)", clarifying that the Chinese medicine compound preparations managed in accordance with the catalogue of ancient classic prescriptions belong to Chinese medicine registration classification 3.
1 (hereinafter referred to as Chinese medicine 3.
1)
.
Specifically, the formulation of the technical guidelines aims to better carry out the pharmaceutical research of Chinese medicine 3.
1 category
.
The technical guidelines mainly focus on the characteristics of the 3.
1 types of traditional Chinese medicines to elaborate the relevant requirements, and clarify the basic principles of the 3.
1 types of pharmacy researches of the traditional Chinese medicines.
The contents mainly include the research of medicinal materials, the research of decoction pieces, the research of reference samples, the research of preparation production, the research of preparation quality and quality standards, and the correlation.
aspects of research, research stability
.
It is worth noting that, in order to further promote the development of Chinese medicine, all parts of the country are currently vigorously promoting the innovative development of Chinese medicine
.
For example, at the beginning of this month, the "Fourteenth Five-Year Plan for the Development of Traditional Chinese Medicine in Shanghai" organized and formulated by the Shanghai Municipal Health Commission and the Municipal Administration of Traditional Chinese Medicine has put a lot of effort into "high" and "new", and will expand comprehensive reforms.
Integration and accessibility, strengthen technological innovation and the construction of high-quality talent teams, and promote high-quality service capabilities and industrial energy levels
.
In addition, the "Plan" also clearly mentions that by 2025, Shanghai will basically build a highland of Chinese medicine system construction, a highland of Chinese medicine health services, and a highland of Chinese medicine innovation sources.
Shanghai Chinese medicine services, governance, talent support, inheritance and innovation, Culture leads the continuous improvement of the five major capabilities and serves the integrated and high-quality development of the Yangtze River Delta
.
With the help of a series of policies, in order to seize the development opportunities, Chinese medicine companies have begun to strengthen the research and development of Chinese medicine products
.
Affected by this, more and more new Chinese medicines have also emerged in the industry
.
On the whole, compared with the whole year of 2020, the number of new Chinese medicine registration applications has increased by more than 80% so far this year; in addition to the record high number of new Chinese medicine registration applications, the distribution of new Chinese medicines in the therapeutic field is also increasing.
The more abundant it is, it includes drugs such as digestive system, respiratory system, and cardiovascular and cerebrovascular diseases
.
In short, innovative research and development of traditional Chinese medicine is rapidly emerging
.
The industry predicts that with the revitalization of traditional Chinese medicine as a national strategy and the "Thirteenth Five-Year Plan" for the development of traditional Chinese medicine, the market for the health industry of traditional Chinese medicine will continue to grow rapidly, and relevant innovations will continue to emerge.
.
.
However, in recent years, with the acceleration of Chinese medicine registration and approval, Chinese medicine has ushered in innovative development, and the number of innovative Chinese medicines approved has continued to increase
.
According to statistics, as of December 16, 58 new TCM drug applications and registrations have been accepted in 2021 (accepted numbers, the same below), which is an increase of 114.
81% compared to 2020; both of which apply for clinical application or application for marketing.
There were 48 and 10 record highs respectively
.
Among them, category 1 innovative drugs accounted for 86.
21% of the total new TCM drugs, including 36 category 1.
1 new drugs, 10 category 1.
2 new drugs, and 4 category 1.
3 drugs
.
Analysis believes that the continuous increase in the number of innovative Chinese medicines approved is closely related to policy assistance
.
It is understood that in order to encourage innovation in traditional Chinese medicine, the country has issued a series of documents in recent years
.
For example, on August 27, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for the Pharmaceutical Research of Chinese Medicine Compound Preparations Managed in the Catalogue of Ancient Classical Prescriptions (for Trial Implementation)", clarifying that the Chinese medicine compound preparations managed in accordance with the catalogue of ancient classic prescriptions belong to Chinese medicine registration classification 3.
1 (hereinafter referred to as Chinese medicine 3.
1)
.
Specifically, the formulation of the technical guidelines aims to better carry out the pharmaceutical research of Chinese medicine 3.
1 category
.
The technical guidelines mainly focus on the characteristics of the 3.
1 types of traditional Chinese medicines to elaborate the relevant requirements, and clarify the basic principles of the 3.
1 types of pharmacy researches of the traditional Chinese medicines.
The contents mainly include the research of medicinal materials, the research of decoction pieces, the research of reference samples, the research of preparation production, the research of preparation quality and quality standards, and the correlation.
aspects of research, research stability
.
It is worth noting that, in order to further promote the development of Chinese medicine, all parts of the country are currently vigorously promoting the innovative development of Chinese medicine
.
For example, at the beginning of this month, the "Fourteenth Five-Year Plan for the Development of Traditional Chinese Medicine in Shanghai" organized and formulated by the Shanghai Municipal Health Commission and the Municipal Administration of Traditional Chinese Medicine has put a lot of effort into "high" and "new", and will expand comprehensive reforms.
Integration and accessibility, strengthen technological innovation and the construction of high-quality talent teams, and promote high-quality service capabilities and industrial energy levels
.
In addition, the "Plan" also clearly mentions that by 2025, Shanghai will basically build a highland of Chinese medicine system construction, a highland of Chinese medicine health services, and a highland of Chinese medicine innovation sources.
Shanghai Chinese medicine services, governance, talent support, inheritance and innovation, Culture leads the continuous improvement of the five major capabilities and serves the integrated and high-quality development of the Yangtze River Delta
.
With the help of a series of policies, in order to seize the development opportunities, Chinese medicine companies have begun to strengthen the research and development of Chinese medicine products
.
Affected by this, more and more new Chinese medicines have also emerged in the industry
.
On the whole, compared with the whole year of 2020, the number of new Chinese medicine registration applications has increased by more than 80% so far this year; in addition to the record high number of new Chinese medicine registration applications, the distribution of new Chinese medicines in the therapeutic field is also increasing.
The more abundant it is, it includes drugs such as digestive system, respiratory system, and cardiovascular and cerebrovascular diseases
.
In short, innovative research and development of traditional Chinese medicine is rapidly emerging
.
The industry predicts that with the revitalization of traditional Chinese medicine as a national strategy and the "Thirteenth Five-Year Plan" for the development of traditional Chinese medicine, the market for the health industry of traditional Chinese medicine will continue to grow rapidly, and relevant innovations will continue to emerge.
.
