The Beijing Municipal Medical Insurance Bureau, in conjunction with eight other bureaus, has announced a set of Measures designed to “Support the High-Quality Development of Innovative Medicine in Beijing.” Released on April 7, 2024, these Measures are open for public feedback until April 9 and encompass a wide range of specific actions aimed at fostering a robust biopharmaceutical ecosystem in the city.
The Measures include 32 detailed initiatives targeting various stages of the pharmaceutical value chain, from research and development to clinical trials, reviews and approvals, production, distribution, and clinical application. A key focus is on leveraging medical and health data innovatively, with the application of artificial intelligence and big data models to support the digitalization and intelligent upgrade of Beijing’s medical and health industry.
The city aims to streamline clinical trial timelines to within 28 weeks and support key enterprises in achieving global synchronization of their trials. The establishment of over 10 regional or specialized clinical research consortia will enhance the assessment and quality control of research wards across Beijing. Social capital is encouraged to invest in research-oriented hospitals, promoting cooperation with local medical institutions and expanding the scope of mutual recognition of medical ethical review results.
The Measures also aim to expedite review timelines for innovative drugs and devices, reducing the review time for drug supplementary applications from 200 days to 60 days and the approval deadline for drug clinical trials from 60 days to 30 days. A key project management mechanism for innovative pharmaceutical enterprises is to be implemented, with the goal of having 200 products included in project management by the end of 2024 and approving 10 new innovative medical devices for market launch in 2024.
Beijing will facilitate pharmaceutical trade by establishing a pilot zone for rare disease drug security, implementing a “white list” system for rare disease drugs, and opening a green channel for one-time approval and multiple imports by multiple medical institutions. The government aims to approve at least 5 imported drug products in 2024 and promote 5 local drugs to gain overseas approvals.
To promote the clinical application of innovative drugs, Beijing will prioritize initiating a unified pricing demonstration process for innovative technology projects, improve the green channel mechanism for innovative medical equipment, and ensure the supply of nationally negotiated drugs in designated retail pharmacies through the “dual channel” mechanism.
The Measures also aim to expand payment channels for innovative drugs by actively carrying out policy lectures, supporting enterprises in national negotiations, and encouraging commercial insurance companies to develop targeted health insurance products covering innovative drugs and devices.
Beijing’s Measures strive to strengthen investment and financing for innovative pharmaceutical companies, aiming to promote the local translational research of globally original technologies and products, including cell and gene therapies and digital medicines.- Flcube.com
