摘要
监管科学(Regulatory science, RS)从最初公共管理为应对所面临的客观风险而提出监管的新工具、新方法和新模式,到现今世界主要药品监管机构共同推动成为21世纪战略性前沿学科,有力促进了全球创新药同步研发、注册与审评。我国药品监管科学的形成和发展,从“科学发展观”战略思想指导下理念萌芽,到药品审评审批制度改革,中国药品监管科学行动计划,药品监管科学全国重点实验室建设,以及中药监管科学(TCM Regulatory science, TCMRS)融合创新,具有鲜明的中国特色和独特的科学内涵。我国药品监管科学体系建设作为国家战略科技力量的组成部分,成为我国构建“科学、高效、权威”药品监管体系的重要科技支撑。尤其是中药监管科学,作为新近发展起来的、具有中西医融合科学特征的新兴学科,业已成为加快打造具有中国特色、符合中药特点、全球领先的中药卓越监管体系(TCM excellent regulatory system, TCMERS)的新工具和新方法。2023年7月国家药监局印发《全面强化药品监管科学体系建设实施方案》,为“十四五”期间进一步推动我国药品监管科学体系进行战略性、前瞻性、系统性布局,对于新时期推进中国式现代化药品监管实践,实现药品高水平安全监管和高质量产业发展,促进中医药传承创新发展均具有重大意义。
Regulatory science, the science of developing new tools, methods, and models for public management to address objective risks, has becomea strategic frontier discipline in the 21st century by the joint efforts of major drug regulatory agencies around the world. It has promotedthe synchronous research and development, registration, and evaluation of innovative drugs worldwide. The emergence and development ofdrug regulatory science in China, from the strategic guidance of the Scientific Outlook on Development, the reform of the drug evaluation andapproval system, the proposal of China's Drug Regulatory Science Action Plan, the building of the National Key Laboratory of Drug RegulatoryScience, to the convergence innovation of TCM Regulatory Science (TCMRS), has distinct Chinese characteristics and unique scientificconnotations. China's drug regulatory science system, as a component of the national strategic scientific and technological strength, has becomea pillar for building a scientific, efficient, and authoritative drug regulatory system in China. Especially, TCMRS, an emerging convergencescience of traditional Chinese and Western Medicine, has become a new tool to accelerate the building of a leading TCM excellent regulatorysystem (TCMERS) with Chinese characteristics and in line with the characteristics of TCM. In July 2023, the National Medical ProductsAdministration issued the Implementation Plan for Comprehensively Building the Drug Regulatory System. This plan is of great significancefor the strategic, forward-looking, and systematic layout of the regulatory science system in China during the 14th Five-Year Plan periodand the modern drug regulation practice with Chinese characteristics in the new era. It will help to achieve high-level safety supervision andhigh-quality industrial development of drugs and encourage the inheritance and innovative development of traditional Chinese medicine.
作者
赵军宁
ZHAO Junning(National Key Laboratory of Drug Regulatory Science,National Medical Products Administration,Beijing 100037)
出处
《中药药理与临床》
CAS
CSCD
北大核心
2024年第2期3-17,共15页
Pharmacology and Clinics of Chinese Materia Medica
关键词
药品监管
药品监管科学
高水平安全监管
高质量产业发展
中药监管科学
中药卓越监管体系
Drug regulation
Drug regulatory science
High-level safety supervision
High-quality industrial development
TCM regulatory science
TCM excellent regulatory system
