Jianbo Qu1, Tideng Zhang2, Jiaxing Liu3, Yuanyuan Su4, Hainan Wang2. 1. China Food and Drug Administration, No. 128 Jianguo Rd, Chaoyang District, Beijing 100022, China. 2. National Medical Products Administration, No. 26, Xuanwumen West St, Xicheng District, Beijing 100053, China. 3. Guizhou University, College of Pharmacy, Huaxi District, Guiyang City 550025, China. 4. China Academy of Chinese Medical Sciences, TCM Clinical Basic Medical Research Institute, No. 16, South Nanxiao St, Dongzhimen, Dongcheng District, Beijing 100700, China.
Abstract
Background: The quality control of traditional Chinese medicine (TCM) has been essential for the development of TCM industry. In recent years, with the acceleration of TCM modernization, research on the quality control of TCM has reached a higher level. Objective: This article suggested a comprehensive approach to the quality control of TCM and proposed specific requirements for the quality control of newly registered TCM in various phases of development. Method: The views in this article are mainly derived from the laws and regulations of China and the authors' experiences. Results: It pointed out that the investigation on the quality control of TCM should be led by Chinese traditional medicine theory and guided by the clinical value. Moreover, it should follow the basic principle of "quality by design" and in-process control to establish a quality control system that embodies the characteristics of TCM and accurately reflects the safety, efficacy, and quality consistency. Given that TCM is a natural resource-dependent industry, the quality control of TCM should also focus on the protection and sustainable use of resources. Conclusions: TCM quality control should organically combine Chinese traditional medicine theory with modern science and technology, be guided by clinical value, pay attention to the protection and sustainable use of resources, fully embody the characteristics of quality by design (QbD) and in-process quality control, and gradually establish a quality control system in accordance with the features of Chinese traditional medicine. Highlights: The article has guiding significance for the research and development of newly registered TCM.
Background: The quality control of traditional Chinese medicine (TCM) has been essential for the development of TCM industry. In recent years, with the acceleration of TCM modernization, research on the quality control of TCM has reached a higher level. Objective: This article suggested a comprehensive approach to the quality control of TCM and proposed specific requirements for the quality control of newly registered TCM in various phases of development. Method: The views in this article are mainly derived from the laws and regulations of China and the authors' experiences. Results: It pointed out that the investigation on the quality control of TCM should be led by Chinese traditional medicine theory and guided by the clinical value. Moreover, it should follow the basic principle of "quality by design" and in-process control to establish a quality control system that embodies the characteristics of TCM and accurately reflects the safety, efficacy, and quality consistency. Given that TCM is a natural resource-dependent industry, the quality control of TCM should also focus on the protection and sustainable use of resources. Conclusions: TCM quality control should organically combine Chinese traditional medicine theory with modern science and technology, be guided by clinical value, pay attention to the protection and sustainable use of resources, fully embody the characteristics of quality by design (QbD) and in-process quality control, and gradually establish a quality control system in accordance with the features of Chinese traditional medicine. Highlights: The article has guiding significance for the research and development of newly registered TCM.