The benefits of traditional Chinese medicine innovation are coming one after another!

On January 5, the website of the Drug Evaluation Center of the State Food and Drug Administration released the "Technical Guidelines for Communication and Communication under the "Three Combinations" Registration Review Evidence System (Draft for Comment)" (hereinafter referred to as the "Draft for Comments"), the time limit for soliciting comments 1 month from the date of publication
.

 

For new Chinese medicines developed under the Chinese medicine registration review evidence system (hereinafter referred to as the "three-combination" review evidence system) that combines Chinese medicine theory, human experience, and clinical trials, it proposes different registration categories for clinical communication and exchange.
Key milestones, meeting material requirements, and concerns, including human experience data
.

 

Highlight the key role of human experience

 

The "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" issued in October 2019 put forward the requirements of the "three-in-one" review evidence system
.
Based on the research and development rules of traditional Chinese medicines, the "Registration Classification of Traditional Chinese Medicines and Application Materials Requirements" issued by the State Food and Drug Administration has adjusted the registration classification of traditional Chinese medicines, focusing on optimizing the registration and application path of traditional Chinese medicine compound preparations reflecting the characteristics of traditional Chinese medicines, and enriching the ancient classic and famous traditional Chinese medicine compound prescriptions.
range of formulations
.
At the same time, different technical requirements are formulated according to whether the varieties are developed in accordance with the "three-in-one" review evidence system
.

 

　　With the "three-in-one" review evidence system, the relevant guiding principles and technical requirements are being continuously enriched and improved through review practice
.
The opinion draft clarifies the communication concerns of Category 1.
1 Chinese medicine compound preparations, Category 3.
1 Chinese medicine compound preparations managed according to the catalogue of ancient classic prescriptions, and Category 3.
2 other traditional Chinese medicine compound preparations derived from ancient classic prescriptions, etc.
According to the requirement of expert review of Chinese herbal compound preparations, based on the need for completeness of application materials in expert review, the requirements for meeting materials at the communication stage are put forward
.

 

　　Among them, for Category 1.
1 Chinese medicine compound preparations, the focus of communication and communication is on Chinese medicine theory, human experience and clinical trials
.
The Opinion Draft points out that at each key stage of the research and development of Category 1.
1 Chinese medicines, applicants should, based on the therapeutic advantages and characteristics of Chinese medicines developed, closely follow the clinical positioning, and continuously and dynamically evaluate the impact of existing research data on the proposed functions, indications, efficacy and safety.
It can answer the clinical questions that must be answered for the drug listing, the level of support for the registration application matters, and rationally plan the research and development path according to the characteristics of the variety
.

 

　　It is worth noting that the opinion draft highlights the key role of human experience in the "three-in-one" review evidence system, and summarizes the communication and exchange of human experience into the communication of human experience research plans and the communication of human experience data.
, and put forward meeting material requirements and concerns respectively
.
At the same time, pre-designed clinical studies to gain human experience are encouraged in the early R&D stage
.

 

　　For a long time, the main sources of human experience in traditional Chinese medicine are ancient medical records, preparations of medical institutions, and expert experience prescriptions of famous and old Chinese medicine
.
With the implementation of TCM innovation supervision policies, industry experts generally believe that "human use experience" is not directly equivalent to "human use data", nor is it simply stacking medical records, but it needs to be summarized as "human use evidence" through rigorous argumentation.
"
.
Therefore, the process of acquiring human experience is a process of gradually exploring and clarifying the effectiveness, safety characteristics and clinical value of traditional Chinese medicine compound preparations, and its research can run through the whole process of drug development
.

 

　　Policy bonus superposition

 

　　In recent years, the state has issued a series of policy documents to guide the work of traditional Chinese medicine, making it clear that the creation of new traditional Chinese medicines is one of the key tasks in the development of traditional Chinese medicine, and establishing a traditional Chinese medicine characteristic review evidence system that combines traditional Chinese medicine theory, human experience, and clinical trials.
It has brought new historical development opportunities for the research and development of new Chinese medicines
.

 

　　In 2021, a total of 12 new Chinese medicines were approved by the NMPA, making it the year with the largest number of new Chinese medicines approved in the past five years
.
Among them, Yinqiao Qingre Tablets from Kangyuan Pharmaceutical is the first innovative Chinese medicine drug approved for marketing since the implementation of the new Chinese medicine registration classification on July 1, 2020; Tasly’s Kunxinning Granules are used in traditional Chinese medicine for female menopausal syndrome Syndrome differentiation belongs to the treatment of deficiency of kidney yin and yang; Yili Pharmaceutical's Huzhen Qingfeng Capsules is used for the treatment of mild to moderate acute gouty arthritis due to TCM syndrome differentiation of damp-heat accumulation syndrome; Yiling Pharmaceutical's Jieyu Chufan Capsules, It is used for the treatment of TCM syndrome differentiation of mild to moderate depression, which belongs to the syndrome of qi stagnation and phlegm obstruction and stagnation and fire
.

 

　　It is worth noting that the above varieties are innovative TCM drugs developed on the basis of TCM clinical experience.
The modern evidence-based evidence obtained through randomized, double-blind, placebo-controlled, multi-center clinical trials, and multi-center clinical studies.
It has been highly recognized by the drug regulatory authorities
.

 

　　New Chinese medicines approved by NMPA in 2021

 

　　Adhere to the orientation of clinical value, build a "three-in-one" Chinese medicine evaluation evidence system of traditional Chinese medicine theory, human experience and clinical trials, and promote the establishment of efficacy evaluation standards that are compatible with the clinical positioning of traditional Chinese medicine and reflect its function characteristics and advantages.
An important innovation path for traditional Chinese medicine to move towards high-quality development in the new era
.

 

　　In addition, in 2021, the State Food and Drug Administration also urgently approved the "three prescriptions" of the "three medicines and three prescriptions" that have made "competitive achievements" in the new crown epidemic - Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules.
, the "three parties" are registered and listed in accordance with the 3.
1 category
.
It can be seen that the reform of the evaluation and approval system for the characteristics of traditional Chinese medicine has achieved initial results, and innovative traditional Chinese medicine drugs have ushered in new development opportunities
.

 

　　In recent years, the state has issued a series of policy documents to guide the work of traditional Chinese medicine, incorporating traditional Chinese medicine into the national development plan, and laying a solid foundation for the traditional Chinese medicine market
.
Relevant policies continue to promote the coordinated development of Chinese and Western medicine, creating a better growth environment for the Chinese medicine industry
.

 

　　On February 9, 2021, the General Office of the State Council issued the "Several Policies and Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics", requiring further implementation of the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" and the deployment of the National Convention on Traditional Chinese Medicine.
The law of medical development, conscientiously summarize the experience and practices of traditional Chinese medicine in the prevention and treatment of new coronary pneumonia, solve existing problems, give better play to the characteristics and comparative advantages of traditional Chinese medicine, and promote the complementary and coordinated development of traditional Chinese medicine and Western medicine
.

 

　　On June 30, 2021, the "Opinions on Further Strengthening the Work of Traditional Chinese Medicine in General Hospitals to Promote the Coordinated Development of Traditional Chinese and Western Medicine" was released
.
Further improve the related system of TCM and Western medicine collaboration, strengthen the setting up of TCM clinical departments and TCM pharmacies in general hospitals, and innovate the guiding opinions on TCM and Western medicine collaborative medical care models
.

 

　　On October 11, 2021, the Guangdong Medical Insurance Bureau issued the "Guiding Opinions of the Guangdong Medical Insurance Bureau on Carrying out Medical Insurance Payment Reform to Promote the Inheritance, Innovation and Development of Traditional Chinese Medicine", proposing various measures to promote the reform of medical insurance payment for traditional Chinese medicine services, aiming to deepen The reform of the medical insurance payment system will promote the high-quality development of traditional Chinese medicine and meet the people's demand for traditional Chinese medicine services
.

 

　　On December 30, 2021, the National Medical Insurance Administration and the State Administration of Traditional Chinese Medicine jointly issued the "Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine", which clearly pointed out that general TCM medical services can continue to be paid by project, and TCM medical institutions can Do not implement DRG payment for the time being, and appropriately increase the coefficient and score of TCM medical institutions and TCM disease types in areas that have implemented DRG and payment based on disease types
.

 

　　Chinese medicine sector rose in response

 

　　Affected by a number of favorable policies, the commercial value of the traditional Chinese medicine sector has been increasingly recognized by the capital market
.
On January 6, the traditional Chinese medicine sector rose again by 3.
77%, Shanghai Kaibao rose 10.
92%, Zuoli Pharmaceutical, Jianming Group, Xinguang Pharmaceutical, etc.
rose ahead of schedule, Red Sun Pharmaceutical, Kanghui Pharmaceutical, Xintian Pharmaceutical, Renhe Pharmaceutical.
, Qianjin Pharmaceutical, etc.
daily limit
.
It is worth noting that the cumulative increase of Hongri Pharmaceutical since December 21, 2021 has reached 110.
41%
.

 

　

 

 

　　The industrial and capital dividends released by the new stage of development in the field of traditional Chinese medicine mainly reflect the industry's strong demand for high-quality innovation
.
The release of the draft for comments will surely promote the communication and interaction between enterprise applicants and regulatory authorities, accelerate the transformation of drugs into the market, and further improve the innovation capability of traditional Chinese medicines
.

 

 

 

　　On January 5, the website of the Drug Evaluation Center of the State Food and Drug Administration released the "Technical Guidelines for Communication and Communication under the "Three Combinations" Registration Review Evidence System (Draft for Comment)" (hereinafter referred to as the "Draft for Comments"), the time limit for soliciting comments 1 month from the date of publication
.

 

　　For new Chinese medicines developed under the Chinese medicine registration review evidence system (hereinafter referred to as the "three-combination" review evidence system) that combines Chinese medicine theory, human experience, and clinical trials, it proposes different registration categories for clinical communication and exchange.
Key milestones, meeting material requirements, and concerns, including human experience data
.

 

　　Highlight the key role of human experience

 

　　The "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" issued in October 2019 put forward the requirements of the "three-in-one" review evidence system
.
Based on the research and development rules of traditional Chinese medicines, the "Registration Classification of Traditional Chinese Medicines and Application Materials Requirements" issued by the State Food and Drug Administration has adjusted the registration classification of traditional Chinese medicines, focusing on optimizing the registration and application path of traditional Chinese medicine compound preparations reflecting the characteristics of traditional Chinese medicines, and enriching the ancient classic and famous traditional Chinese medicine compound prescriptions.
range of formulations
.
At the same time, different technical requirements are formulated according to whether the varieties are developed in accordance with the "three-in-one" review evidence system
.

 

　　With the "three-in-one" review evidence system, the relevant guiding principles and technical requirements are being continuously enriched and improved through review practice
.
The opinion draft clarifies the communication concerns of Category 1.
1 Chinese medicine compound preparations, Category 3.
1 Chinese medicine compound preparations managed according to the catalogue of ancient classic prescriptions, and Category 3.
2 other traditional Chinese medicine compound preparations derived from ancient classic prescriptions, etc.
According to the requirement of expert review of Chinese herbal compound preparations, based on the need for completeness of application materials in expert review, the requirements for meeting materials at the communication stage are put forward
.

 

　　Among them, for Category 1.
1 Chinese medicine compound preparations, the focus of communication and communication is on Chinese medicine theory, human experience and clinical trials
.
The Opinion Draft points out that at each key stage of the research and development of Category 1.
1 Chinese medicines, applicants should, based on the therapeutic advantages and characteristics of Chinese medicines developed, closely follow the clinical positioning, and continuously and dynamically evaluate the impact of existing research data on the proposed functions, indications, efficacy and safety.
It can answer the clinical questions that must be answered for the drug listing, the level of support for the registration application matters, and rationally plan the research and development path according to the characteristics of the variety
.

 

　　It is worth noting that the opinion draft highlights the key role of human experience in the "three-in-one" review evidence system, and summarizes the communication and exchange of human experience into the communication of human experience research plans and the communication of human experience data.
, and put forward meeting material requirements and concerns respectively
.
At the same time, pre-designed clinical studies to gain human experience are encouraged in the early R&D stage
.

 

　　For a long time, the main sources of human experience in traditional Chinese medicine are ancient medical records, preparations of medical institutions, and expert experience prescriptions of famous and old Chinese medicine
.
With the implementation of TCM innovation supervision policies, industry experts generally believe that "human use experience" is not directly equivalent to "human use data", nor is it simply stacking medical records, but it needs to be summarized as "human use evidence" through rigorous argumentation.
"
.
Therefore, the process of acquiring human experience is a process of gradually exploring and clarifying the effectiveness, safety characteristics and clinical value of traditional Chinese medicine compound preparations, and its research can run through the whole process of drug development
.

 

　　Policy bonus superposition

 

　　In recent years, the state has issued a series of policy documents to guide the work of traditional Chinese medicine, making it clear that the creation of new traditional Chinese medicines is one of the key tasks in the development of traditional Chinese medicine, and establishing a traditional Chinese medicine characteristic review evidence system that combines traditional Chinese medicine theory, human experience, and clinical trials.
It has brought new historical development opportunities for the research and development of new Chinese medicines
.

 

　　In 2021, a total of 12 new Chinese medicines were approved by the NMPA, making it the year with the largest number of new Chinese medicines approved in the past five years
.
Among them, Yinqiao Qingre Tablets from Kangyuan Pharmaceutical is the first innovative Chinese medicine drug approved for marketing since the implementation of the new Chinese medicine registration classification on July 1, 2020; Tasly’s Kunxinning Granules are used in traditional Chinese medicine for female menopausal syndrome Syndrome differentiation belongs to the treatment of deficiency of kidney yin and yang; Yili Pharmaceutical's Huzhen Qingfeng Capsules is used for the treatment of mild to moderate acute gouty arthritis due to TCM syndrome differentiation of damp-heat accumulation syndrome; Yiling Pharmaceutical's Jieyu Chufan Capsules, It is used for the treatment of TCM syndrome differentiation of mild to moderate depression, which belongs to the syndrome of qi stagnation and phlegm obstruction and stagnation and fire
.

 

　　It is worth noting that the above varieties are innovative TCM drugs developed on the basis of TCM clinical experience.
The modern evidence-based evidence obtained through randomized, double-blind, placebo-controlled, multi-center clinical trials, and multi-center clinical studies.
It has been highly recognized by the drug regulatory authorities
.

 

　　New Chinese medicines approved by NMPA in 2021

 

　　Adhere to the orientation of clinical value, build a "three-in-one" Chinese medicine evaluation evidence system of traditional Chinese medicine theory, human experience and clinical trials, and promote the establishment of efficacy evaluation standards that are compatible with the clinical positioning of traditional Chinese medicine and reflect its function characteristics and advantages.
An important innovation path for traditional Chinese medicine to move towards high-quality development in the new era
.

 

　　In addition, in 2021, the State Food and Drug Administration also urgently approved the "three prescriptions" of the "three medicines and three prescriptions" that have made "competitive achievements" in the new crown epidemic - Qingfei Paidu Granules, Huashi Baidu Granules, and Xuanfei Baidu Granules.
, the "three parties" are registered and listed in accordance with the 3.
1 category
.
It can be seen that the reform of the evaluation and approval system for the characteristics of traditional Chinese medicine has achieved initial results, and innovative traditional Chinese medicine drugs have ushered in new development opportunities
.

 

　　In recent years, the state has issued a series of policy documents to guide the work of traditional Chinese medicine, incorporating traditional Chinese medicine into the national development plan, and laying a solid foundation for the traditional Chinese medicine market
.
Relevant policies continue to promote the coordinated development of Chinese and Western medicine, creating a better growth environment for the Chinese medicine industry
.

 

　　On February 9, 2021, the General Office of the State Council issued the "Several Policies and Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics", requiring further implementation of the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" and the deployment of the National Convention on Traditional Chinese Medicine.
The law of medical development, conscientiously summarize the experience and practices of traditional Chinese medicine in the prevention and treatment of new coronary pneumonia, solve existing problems, give better play to the characteristics and comparative advantages of traditional Chinese medicine, and promote the complementary and coordinated development of traditional Chinese medicine and Western medicine
.

 

　　On June 30, 2021, the "Opinions on Further Strengthening the Work of Traditional Chinese Medicine in General Hospitals to Promote the Coordinated Development of Traditional Chinese and Western Medicine" was released
.
Further improve the related system of TCM and Western medicine collaboration, strengthen the setting up of TCM clinical departments and TCM pharmacies in general hospitals, and innovate the guiding opinions on TCM and Western medicine collaborative medical care models
.

 

　　On October 11, 2021, the Guangdong Medical Insurance Bureau issued the "Guiding Opinions of the Guangdong Medical Insurance Bureau on Carrying out Medical Insurance Payment Reform to Promote the Inheritance, Innovation and Development of Traditional Chinese Medicine", proposing various measures to promote the reform of medical insurance payment for traditional Chinese medicine services, aiming to deepen The reform of the medical insurance payment system will promote the high-quality development of traditional Chinese medicine and meet the people's demand for traditional Chinese medicine services
.

 

　　On December 30, 2021, the National Medical Insurance Administration and the State Administration of Traditional Chinese Medicine jointly issued the "Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine", which clearly pointed out that general TCM medical services can continue to be paid by project, and TCM medical institutions can Do not implement DRG payment for the time being, and appropriately increase the coefficient and score of TCM medical institutions and TCM disease types in areas that have implemented DRG and payment based on disease types
.

 

　　Chinese medicine sector rose in response

 

　　Affected by a number of favorable policies, the commercial value of the traditional Chinese medicine sector has been increasingly recognized by the capital market
.
On January 6, the traditional Chinese medicine sector rose again by 3.
77%, Shanghai Kaibao rose 10.
92%, Zuoli Pharmaceutical, Jianming Group, Xinguang Pharmaceutical, etc.
rose ahead of schedule, Red Sun Pharmaceutical, Kanghui Pharmaceutical, Xintian Pharmaceutical, Renhe Pharmaceutical.
, Qianjin Pharmaceutical, etc.
daily limit
.
It is worth noting that the cumulative increase of Hongri Pharmaceutical since December 21, 2021 has reached 110.
41%
.

 

　

 

 

　　The industrial and capital dividends released by the new stage of development in the field of traditional Chinese medicine mainly reflect the industry's strong demand for high-quality innovation
.
The release of the draft for comments will surely promote the communication and interaction between enterprise applicants and regulatory authorities, accelerate the transformation of drugs into the market, and further improve the innovation capability of traditional Chinese medicines
.