By Fineline Cube 
The General Office of the People’s Government of Hainan Province has released the “Implementation Plan for Comprehensively Deepening Reform in Drug, Medical Device, and Cosmetic Regulation to Promote High-Quality Development of the Pharmaceutical Industry.” The plan outlines 20 measures across five key areas to enhance regulatory efficiency and drive industry innovation.
Enhancing Review and Approval Efficiency
- Strengthen pre-submission guidance for product registration and leverage the Haikou National High-Tech Zone Medical Device Innovation Service Station.
- Prioritize review for eligible products, including digital therapeutics, with a target of over 20% annual growth in Class II medical device registrations from 2025 to 2027.
- Optimize review mechanisms for innovative products by accelerating market entry and reducing review timelines by 55% below statutory requirements.
- Aim for at least one innovative product approval annually and a 20%+ annual growth in Class III medical device approvals.
- Pursue national pilot reforms for optimized drug supplementary application reviews by 2026 and advance third-class innovative medical device approvals within two years.
Driving Innovation in Biopharmaceuticals
- Increase clinical research capacity by adding 5+ clinical trial institutions and 1 non-clinical safety evaluation center by 2027.
- Boost R&D support for Traditional Chinese Medicine (TCM) innovation.
- Regularly update the Hainan Innovative Medical Products Catalog and establish pricing mechanisms for first-launch innovative devices.
Strengthening Quality-Centric Competitiveness
- Promote quality standards and strengthen manufacturing oversight.
- Support generic drug quality improvements and expedite approvals for first-to-market generic products.
- Enhance inspection efficiency and product safety monitoring.
Regulatory Innovation and Global Collaboration
- Launch a Three-Year Real-World Research (RWR) Action Plan (2025–2027), facilitating 3–5 international innovative products annually for RWR and 2–3 approvals via RWR data.
- Pilot segmented production models for biologics and explore cross-border segmented production of imported APIs.
- Streamline medical product imports and support the Lecheng International Medical Tourism Pilot Zone in hosting the annual Lecheng BD Conference.
- Promote domestic product globalization and improve supply chain oversight.
Building a Modern Regulatory Framework
- Optimize medical product supervision and expand testing capabilities by adding 3,000 m² of drug testing facilities by 2025 through provincial-municipal partnerships.
- Achieve full testing capacity for non-batch-release biologics by 2026 and build advanced testing capabilities for blood products, cell/gene therapies, and other batch-release biologics.
- Implement AI-assisted review systems and explore hybrid “AI + manual” review models.-Fineline Info & Tech