Shandong province has announced a comprehensive set of measures aimed at optimizing review and approval services and fostering high-quality development in the pharmaceutical sector. The initiatives include supporting innovative R&D, providing financial incentives, enhancing inspection and testing capabilities, improving review and approval efficiency, and aiding in product promotion and standards development.
- The province will back innovative R&D in biomedicine, traditional Chinese medicine (TCM), and high-end medical devices, fostering new contract research and development production models and attracting competitive CROs and CDMOs. It also encourages open innovation collaborations between academia and industry.
- Financial support for R&D will be provided to companies conducting Phase I, II, and III clinical trials in Shandong, with a maximum of 40% of R&D investment costs reimbursed, capped at RMB 10 million, RMB 20 million, and RMB 30 million respectively. The total annual support for each company will not exceed RMB 100 million. For national innovative medical devices in the special review process, up to RMB 2 million in financial support will be available.
- Efforts will be made to enhance inspection and testing services by connecting with enterprise needs, constructing regulatory service platforms, and establishing authorized testing labs for radioactive drugs. A comprehensive inspection and testing matrix will be built in collaboration with relevant provincial institutes and third-party services.
- The efficiency of review and approval services will be improved with a tracking service system for key parks, projects, and products, offering “one-on-one” full-process services for innovative and priority products. The review and inspection processes will be optimized to reduce average inspection times for passive and active medical devices and diagnostic reagents.
- The province will assist in product promotion by simplifying online listing procedures and improving the green channel for initial listings of innovative products. It aims to strengthen standards and brand building, creating a high-end pharmaceutical innovation and development exchange platform. By 2025, Shandong plans to promote the formulation and revision of over 10 national and industry standards for medical devices.- Flcube.com
