National Medical Products Administration: Multiple measures to promote the inheritance, innovation and development of traditional Chinese medicine
2024-09-13
Zhao Junning, Deputy Director of the National Medical Products Administration, stated on the 13th that the administration conscientiously implements the decisions and arrangements of the Party Central Committee and the State Council, adheres to upholding integrity and innovation, and takes multiple measures to promote the inheritance, innovation, and development of traditional Chinese medicine. On September 13th, the State Council Information Office held a series of themed press conferences on promoting high-quality development. At the meeting, a reporter asked: What work has the drug regulatory department carried out in promoting the inheritance, innovation and development of traditional Chinese medicine? Zhao Junning stated that the National Medical Products Administration conscientiously implements the decisions and deployments of the Party Central Committee and the State Council, adheres to upholding integrity and innovation, and takes multiple measures to promote the inheritance, innovation, and development of traditional Chinese medicine. One is to improve the regulatory system and lead the development of traditional Chinese medicine. We will promote the revision of the Implementation Regulations of the Drug Administration Law and the Regulations on the Protection of Traditional Chinese Medicine Varieties. We have successively issued the Special Regulations on the Registration and Management of Traditional Chinese Medicine, the Special Regulations on the Management of Traditional Chinese Medicine Standards, and the Special Regulations on the Supervision and Management of Traditional Chinese Medicine Production that are currently being studied and formulated, including the previously issued Quality Management Standards for Traditional Chinese Medicine Production, also known as the "GAP for Traditional Chinese Medicine", actively strengthening the construction of the regulatory system. The National Medical Products Administration has also issued the "Several Measures to Further Strengthen the Scientific Supervision of Traditional Chinese Medicine and Promote the Inheritance, Innovation and Development of Traditional Chinese Medicine", with a total of 35 measures introduced to follow the characteristics of traditional Chinese medicine supervision and promote the inheritance, innovation and development of traditional Chinese medicine in all aspects and throughout the entire chain. Secondly, reform the review and approval process to promote the development of traditional Chinese medicine. Fully respect the development laws of traditional Chinese medicine, innovate and construct a Chinese medicine registration and evaluation evidence system that combines traditional Chinese medicine theory, human experience, and clinical trials. Through the evidence of "three combinations", clarify and articulate the logic of the safety, effectiveness, and controllable quality of traditional Chinese medicine, and support the launch of new Chinese medicine drugs. In recent years, the enthusiasm for the research and development of new traditional Chinese medicine drugs has continued to surge, with a synchronous increase in the number of clinical trials, market applications, and approvals for these drugs, both reaching double digits in the past two years. In 2023, a total of 10 new traditional Chinese medicine drugs were approved for market, and 8 new drugs have been launched this year, providing new options to meet clinical needs. The third is to establish a regulatory system to safeguard the development of traditional Chinese medicine. The National Medical Products Administration adheres to problem oriented and risk management, and continues to implement a combination of annual special inspections, causal inspections, sampling and exploratory research on traditional Chinese medicine production, as well as quality monitoring of Chinese medicinal materials. Continuously deepen the action of consolidating and improving drug safety, strengthen the supervision of online drug sales, and optimize the circulation and operation order of traditional Chinese medicine. Explore standardized processing of traditional Chinese medicine in production areas, guide the orderly development of traditional Chinese medicine production in production areas, and promote the improvement of traditional Chinese medicine quality from the source. The overall qualification rate of Chinese medicine decoction pieces has risen from 88% in 2018 to about 97% at present, and the overall qualification rate of traditional Chinese patent medicines and simple preparations has been stable at more than 99% for a long time, effectively ensuring that Chinese medicine plays an important role in the clinical practice of Chinese medicine. The demonstration and promotion of GAP in traditional Chinese medicine have achieved initial results, effectively stimulating the endogenous motivation of Chinese medicine production enterprises. (New Society)
Edit:HAN ZHUOLING Responsible editor:CAICAI
Source:chinanews.com
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