Progress and reflections on policy of innovation pharmaceuticals and medical devices in China
10.12206/j.issn.2097-2024.202504055
- VernacularTitle:中国创新药械政策进展与思考
- Author:
Miao LIN
1
;
Yonghe FEI
1
;
Lijun CUI
1
;
Jing CHEN
1
Author Information
1. Department of Pharmacy, Naval Medical University, Shanghai 200433, China.
- Publication Type:Pharmacyadministration
- Keywords:
innovative pharmaceuticals and devices;
policy research;
implementation effectiveness;
future challenges
- From:
Journal of Pharmaceutical Practice and Service
2025;43(11):577-582
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, China has systematically enhanced its policy framework for innovative pharmaceuticals and medical devices and established a comprehensive, full-cycle support mechanism encompassing research and development, regulatory approval, manufacturing, reimbursement, and clinical application. This integrated approach has markedly accelerated the review-approval process and market entry of innovative medical products. Key regions including Beijing, Shanghai and the Guangdong-Hong Kong-Macao Greater Bay Area have demonstrated significant achievements through initiatives such as optimized clinical trial protocols, expedited regulatory pathways, and diversified payment models. Nevertheless, challenges persist, including restrictive performance metrics in hospital, underdeveloped multi-payer reimbursement systems, and interdepartmental coordination gaps. Moving forward, sustained efforts in policy harmonization, reimbursement mechanism innovation, core technology breakthroughs, and global collaboration should be critical to advancing the high-quality development of Chinese innovative pharmaceuticals and devices.
