During a press conference on September 13, organized by China’s State Council Information Office under the theme “Promoting High-Quality Development,” Deputy Director Zhao Junning of the National Medical Products Administration (NMPA) fielded questions regarding the agency’s efforts to advance the innovation and preservation of traditional Chinese medicine (TCM).
Zhao highlighted the NMPA’s commitment to implementing directives from the Central Committee of the Communist Party of China and the State Council. He emphasized the importance of balancing integrity with innovation, outlining several strategies designed to nurture the growth and legacy of TCM.
He pointed out three primary areas of focus:
Firstly, Zhao mentioned that the NMPA is enhancing its regulatory framework to better support the development of traditional Chinese medicine. This includes revising critical legislation, such as the “Regulations on the Implementation of the Drug Administration Law” and the “Regulations on the Protection of Traditional Chinese Medicine Varieties.” Additionally, the NMPA has established specific guidelines for the registration and standard management of TCM, including the “Good Agricultural Practices for TCM Materials.” These measures collectively strengthen the overall regulatory system and introduce 35 new policies aimed at improving scientific oversight of TCM while promoting its innovative potential.
Secondly, Zhao discussed the reforms being made in the review and approval processes to further TCM’s advancement. Recognizing TCM’s unique developmental traits, the NMPA has implemented a new evidence framework for TCM registration. This system integrates theoretical knowledge, empirical experiences, and clinical trials to clarify the safety, efficacy, and controllability of TCM products, facilitating a smoother pathway for new TCM drugs to reach the market. There has been a notable increase in R&D for new TCM drugs, with clinical trial applications and approvals seeing significant growth. In 2023 alone, ten new TCM drugs received market approval, eight of which have already launched this year, providing more options to address clinical needs.
Finally, Zhao highlighted the NMPA’s efforts to create a regulatory system that ensures the safe progress of TCM. The agency has placed a strong emphasis on risk management, enhancing annual production inspections and quality monitoring within the TCM sector. This includes regulating online medicine sales and improving the distribution and operational efficiency of TCM materials. The NMPA is also working towards standardizing processing at production sites, ensuring high-quality TCM from the very beginning. Consequently, the overall compliance rate for TCM decoction pieces has risen from 88% in 2018 to approximately 97% today, while the compliance rate for TCM preparations consistently exceeds 99%. These initiatives significantly enhance TCM’s role in clinical practice, demonstrating the success of implementing Good Agricultural Practices (GAP) for TCM materials and effectively boosting the production capabilities of TCM enterprises.
