中国食品药品监管Issue(4)：100-115,16.DOI:10.3969/j.issn.1673-5390.2025.04.010
推进药品监管能力现代化建设和亚太地区国际监管协同:从概念到实践
Advancing the Modernization of Drug Regulatory Capacity and Regulatory Harmonization and Convergence in the Asian-Pacific Region:from Concept to Practices
摘要
Abstract
In recent years,the rapid development of innovative medical technologies and products has positioned Asia-Pacific(APAC)countries and regions as key players in the global pharmaceutical industry.However,significant disparities in regulatory systems and capacities across the region pose challenges,increasing the complexity and delay risks in drug development and approval.Benchmarking has emerged as a powerful tool for assessing and enhancing regulatory systems,thereby accelerating convergence and harmonization within the region.Based on the concept of benchmarking,this study identified and analyzed the practical experiences of the selected APAC countries in advancing the modernization and internationalization of drug regulatory capacities.It focuses on the practices of Japan,South Korea,Singapore,and Thailand in developing frontier technologies(including technological innovation in pharmaceutical products,optimization of review strategies,and the application of real-world evidence in regulatory decision-making),as well as efforts to optimize regulatory frameworks,foster talent development,and promote international regulatory harmonization and convergence.The findings aim to provide valuable references for further enhancing the modernization of China's drug regulatory system and strengthening its role in regulatory cooperation across the Asia-Pacific region and globally.关键词
药品监管/能力建设/基准评估/监管协同/亚太地区Key words
drug regulation/capacity building/benchmarking/regulatory harmonization and convergence/Asia-Pacific Region分类
社会科学引用本文复制引用
时君楠,陈献文,郑榆,王晓红,胡豪,吴霭琳..推进药品监管能力现代化建设和亚太地区国际监管协同:从概念到实践[J].中国食品药品监管,2025,(4):100-115,16.基金项目
澳门特别行政区科学技术发展基金(005/2023/SKL) （005/2023/SKL）
