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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
It is worth noting that the above varieties are innovative TCM drugs developed on the basis of TCM clinical experience.
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%
.
With the "three-in-one" review evidence system, the relevant guiding principles and technical requirements are being continuously enriched and improved through review practice
Among them, for Category 1.
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.
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
Policy bonus superposition
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
It is worth noting that the above varieties are innovative TCM drugs developed on the basis of TCM clinical experience.
In addition, in 2021, the State Food and Drug Administration also urgently approved the "three prescriptions" in 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.
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
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
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 service projects can continue to be paid on a project-by-project basis, and TCM medical institutions can.
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
.
download attachment:
"Guidelines for Communication and Communication Technology under the "Three Combinations" Registration Review Evidence System (Draft for Comments)"
