China News Service, March 29th. Li Yu, Director of the Science and Technology Department of the State Administration of Traditional Chinese Medicine, pointed out on the 29th that during the "14th Five-Year Plan" period, the State Administration of Traditional Chinese Medicine will cooperate with the Ministry of Agriculture and Rural Affairs, the State Drug Administration, the Ministry of Industry and Information Technology, and market supervision. The General Administration and other relevant departments work together to strengthen management of the germplasm sources of Chinese medicinal materials, strengthen the management of the whole process of Chinese medicinal materials planting, industrial production, and circulation, implement the quality improvement project of authentic Chinese medicinal materials, and improve the standardized planting level of Chinese medicinal materials.
The State Council Information Office held a press conference on the 29th to introduce the in-depth implementation of the "14th Five-Year Plan" and promote the development of traditional Chinese medicine, and answer questions from reporters.
A reporter asked that with the continuous increase in public health demand, my country's traditional Chinese medicine industry is developing rapidly, but to a certain extent, there is insufficient high-quality supply. How to further increase production and quality during the "14th Five-Year Plan" period to promote the development of the traditional Chinese medicine industry?
On the other hand, in recent years, a small number of new Chinese medicines have been approved for marketing. This is related to the inconsistency of the past new drug review standards with the characteristics of traditional Chinese medicines. How to establish a review and approval mechanism that meets the characteristics of traditional Chinese medicine during the "14th Five-Year Plan" period ?
"The quality of Chinese medicine is related to the clinical efficacy of Chinese medicine, and it is also related to the development of Chinese medicine and the high-quality development of the Chinese medicine industry. The leading comrades of the central government are very concerned, all sectors of society are also very concerned, and the people are also very concerned." Li Yu pointed out, "Fourteenth During the five-year period, the State Administration of Traditional Chinese Medicine will work with the Ministry of Agriculture and Rural Affairs, the State Food and Drug Administration, the Ministry of Industry and Information Technology, the State Administration of Market Supervision and other relevant departments to strengthen management of the germplasm sources of Chinese medicinal materials, and strengthen the cultivation, industrial production, and circulation of Chinese medicinal materials. Process management, implement the quality improvement project of authentic Chinese medicinal materials, improve the standardized planting level of Chinese medicinal materials, improve the construction of the inspection and testing system of Chinese medicinal materials, strengthen the quality risk assessment and risk monitoring of Chinese medicinal materials, and serve the Chinese medicinal materials, the Chinese medicinal industry, and the circulation industry. High-quality development provides better support, so that the people can use traditional Chinese medicine with confidence.
Li Yu stated that the State Administration of Traditional Chinese Medicine will cooperate with the State Administration of Traditional Chinese Medicine to continue to improve the reform of the examination and approval of Chinese medicines, and promote the research and development of new Chinese medicines and the development of the Chinese medicine industry.
The first is to adhere to the clinical value-oriented approach, promote the establishment of efficacy evaluation standards that are compatible with the clinical positioning of traditional Chinese medicine and reflect its features and advantages, and encourage patient-centered efficacy evaluation.
The second is to promote the development of ancient classic famous prescriptions and traditional Chinese medicine compound preparations, organize research and formulate key information research opinions on ancient classic famous prescriptions, establish a review model compatible with the characteristics of ancient classic famous prescriptions and traditional Chinese medicine compound preparations, and simplify approval procedures.
The third is to build a "three-in-one" review evidence system. Attach importance to the supporting role of “human experience” on the safety and effectiveness of traditional Chinese medicine, and construct an evaluation evidence system that combines traditional Chinese medicine theory, “human experience” and clinical trials in accordance with the characteristics, laws and clinical practice of traditional Chinese medicine. The era of traditional Chinese medicine inheritance and innovation development provides a broader platform and path.