中国食品药品监管Issue(8)：68-79,12.DOI:10.3969/j.issn.1673-5390.2025.08.008
"港澳药械通"政策实施现状分析和优化方向思考
Reflections and Suggestions on the Current Status and Optimization Directions of the"Hong Kong and Macao Medicine and Equipment Connect"Policy
摘要
Abstract
As the"Hong Kong and Macao Medicine and Equipment Connect"policy enters a new phase of institutionalization,this study systematically reviews its implementation data and conducts a comparative analysis with the special licensing policy for drugs and medical devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan.The study finds that the policy has significantly improved access to innovative drugs and devices in the Guangdong-Hong Kong-Macao Greater Bay Area.However,during the pilot phase,challenges remained in terms of product introduction,approval efficiency,balanced participation among institutions,and the application of real-world data(RWD).The Regulations on the Administration of Imported Drugs and Medical Devices from Hong Kong and Macao in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area,effective December 2024,together with supporting documents,have systematically addressed these challenges at the legislative level.Moving forward,the paper suggests that future efforts should focus on promoting refining RWD application standards,establishing an intelligent pharmacovigilance system,exploring strategic synergies with the Hainan Lecheng pilot zone,and deepening regulatory alignment with Hong Kong and Macao to promote high-quality regional development.关键词
粤港澳大湾区/港澳药械通/特许药械/真实世界数据/监管科学Key words
Guangdong-Hong Kong-Macao Greater Bay Area/Hong Kong and Macao Medicine and Equipment Connect/specially licensed pharmaceuticals and medical devices/real-world data/regulatory science分类
医药卫生引用本文复制引用
孙潭霖,吴琪,元延芳,郑杨,房军.."港澳药械通"政策实施现状分析和优化方向思考[J].中国食品药品监管,2025,(8):68-79,12.基金项目
国家药品监督管理局高级研修学院研究项目(NMPAIED102024003) （NMPAIED102024003）
