Huang Ming, Yang Feng-Wen, Zhang Jun-Hua, Zhang Bo-Li
State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Key Laboratory of Evidence-based Evaluation of Traditional Chinese Medicine,National Medical Products Administration Tianjin 301617, China.
State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
Zhongguo Zhong Yao Za Zhi. 2023 Jan;48(1):1-4. doi: 10.19540/j.cnki.cjcmm.20221021.601.
Pharmaceutical products need to ensure the effectiveness, safety and quality controllability through scientific supervision, and as the broad masses of the people are full of new expectations for the supply of high-quality traditional Chinese medicine products, the reform and innovation of traditional Chinese medicine regulatory policies are also facing new opportunities and new challenges. National Medical Products Administration, National Administration of Traditional Chinese Medicine and other relevant departments have implemented the requirements of the Party Central Committee and the State Council, vigorously promoted the reform of the regulatory system in line with the characteristics of traditional Chinese medicine, introduced a series of innovative policies, and achieved phased results. Including the new registration classification standards in line with the characteristics of traditional Chinese medicine, encouraging the development of classical formulas and hospital preparations, encouraging the research and development of symptomatic Chinese medicines, and gra-dually improving the "three-combined " evidence system. However, in the face of the development problems of traditional Chinese medicine in the new era, it is still necessary to improve the scientific supervision system, further optimize the management measures for the registration of traditional Chinese medicines based on classical formulas, accelerate the improvement of the standard system for traditional Chinese medicine formula granules, and form management measures to encourage and support the secondary development of traditional Chinese medicines. In terms of scientific supervision of traditional Chinese medicine, it is necessary to follow the characteristics and development laws of traditional Chinese medicine itself, comprehensively consider the characteristics of epochal, scientific and systematic in regulatory policies, and serve the inheritance and innovative development of traditional Chinese medicine with scientific supervision.
药品需要通过科学监管来确保有效性、安全性和质量可控性,而随着广大人民群众对优质中药产品供应充满新期待,中药监管政策的改革创新也面临新机遇和新挑战。国家药品监督管理局、国家中医药管理局等相关部门贯彻落实党中央、国务院要求,大力推进符合中药特点的监管体制改革,出台了一系列创新政策,取得了阶段性成效。包括符合中药特点的新注册分类标准,鼓励经典名方和医院制剂发展,鼓励对症治疗中药研发,逐步完善“三结合”证据体系等。然而,面对新时代中药发展问题,仍需完善科学监管体系,进一步优化基于经典名方的中药注册管理措施,加快完善中药配方颗粒标准体系,形成鼓励和支持中药二次开发的管理举措。在中药科学监管方面,要遵循中药自身特点和发展规律,综合考量监管政策的时代性、科学性、系统性特点,以科学监管服务中药传承创新发展。