Prospects for Building and Development of the Drug Regulatory Science System in China
Regulatory science,the science of developing new tools,methods,and models for public management to address objective risks,has be-come a strategic frontier discipline in the 21st century by the joint efforts of major drug regulatory agencies around the world.It has promoted the synchronous research and development,registration,and evaluation of innovative drugs worldwide.The emergence and development of drug regulatory science in China,from the strategic guidance of the Scientific Outlook on Development,the reform of the drug evaluation and approval system,the proposal of China's Drug Regulatory Science Action Plan,the building of the National Key Laboratory of Drug Regulato-ry Science,to the convergence innovation of TCM Regulatory Science(TCMRS),has distinct Chinese characteristics and unique scientific connotations.China's drug regulatory science system,as a component of the national strategic scientific and technological strength,has be-come a pillar for building a scientific,efficient,and authoritative drug regulatory system in China.Especially,TCMRS,an emerging conver-gence science of traditional Chinese and Western Medicine,has become a new tool to accelerate the building of a leading TCM excellent regu-latory system(TCMERS)with Chinese characteristics and in line with the characteristics of TCM.In July 2023,the National Medical Prod-ucts Administration issued the Implementation Plan for Comprehensively Building the Drug Regulatory System.This plan is of great signifi-cance for the strategic,forward-looking,and systematic layout of the regulatory science system in China during the 14th Five-Year Plan period and the modern drug regulation practice with Chinese characteristics in the new era.It will help to achieve high-level safety supervision and high-quality industrial development of drugs and encourage the inheritance and innovative development of traditional Chinese medicine.
Drug regulationDrug regulatory scienceHigh-level safety supervisionHigh-quality industrial developmentTCM regulatory scienceTCM excellent regulatory system
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