深化改革引领 服务民生急需 江苏药监推动建议提案办理成果转化为高质量发展实效

Core Insights - Jiangsu Provincial Drug Administration has effectively implemented 46 proposals since 2025, achieving a 100% conversion rate to enhance the innovation momentum of the pharmaceutical industry and improve public medication safety and convenience [1][2]. Group 1: Policy Implementation and Impact - The administration established a mechanism for handling proposals, breaking down 46 proposals into 94 specific tasks, resulting in the resolution of 255 issues for 109 key enterprises and the approval of 324 new drugs and 412 third-class medical devices [2][3]. - The approval of innovative drugs and medical devices accounted for 25% and 16.67% of the national totals, respectively, with 1,512 second-class medical devices also approved, placing Jiangsu at the forefront nationally [2][3]. Group 2: Regulatory Efficiency and Innovation - The establishment of a "green channel" for innovative medical device reviews reduced the review period for major projects to 30 working days, while the average inspection time for active medical devices decreased from 85 to 60 working days [3]. - The implementation of an electronic inspection information management system allows companies to verify reports online, promoting a "zero-run" service model [3]. Group 3: Community and Regional Collaboration - The administration has improved the readability of drug instructions for the elderly by creating simplified versions for 28 commonly used medications, addressing chronic diseases like hypertension and diabetes [4]. - Collaborative efforts in the Yangtze River Delta region have led to unified standards and policies in drug regulation, benefiting local communities [4]. Group 4: Long-term Governance and Quality Development - The administration combines short-term initiatives with long-term governance, optimizing drug supplementary application review processes and successfully approving 14 products, enhancing the speed of major changes post-market [5]. - A guide for pharmaceutical companies on implementing responsibility and a comprehensive governance action for home medical devices have been introduced to mitigate drug safety risks [5]. Group 5: Future Directions and Commitments - The Jiangsu Provincial Drug Administration aims to continue leveraging proposal handling as a catalyst for regulatory reform, ensuring both enterprise development and public safety in medication [6].