Hong Kong Establishes Real-World Study Center to Accelerate Drug Development in Greater Bay Area
核心洞察
The Hong Kong government officially established the Real-World Study and Application Centre (搜索) under the Greater Bay Area International Clinical Trial Institute (搜索) to leverage medical data for drug registration and market entry.
The center will integrate real-world data from Hong Kong-registered drugs and medical devices used in mainland healthcare institutions, with 140 products already benefiting over 17,000 patient visits.
A collaboration with the University of Hong Kong and GSK marks the first real-world data research project, with data collection expected to begin in the second quarter of next year.
The Hong Kong Special Administrative Region Government has officially established the Real-World Study and Application Centre (搜索) (RWSAC) under the Greater Bay Area International Clinical Trial Institute (搜索), marking a significant advancement in regional biomedical development and drug approval processes.
The Health Bureau announced on December 22 that the RWSAC will leverage Hong Kong's unique medical data advantages to support registration applications for innovative drugs and medical devices across Hong Kong, mainland China, and international markets. This initiative aims to accelerate product research and development, approval timelines, and market launch processes.
Real-World Data Integration Shows Early Success
The center will integrate real-world data generated under Hong Kong's special measure allowing Hong Kong-registered drugs and medical devices to be used in mainland public hospitals within the Greater Bay Area. As of December 10, 2024, this program has demonstrated substantial impact, with 71 designated mainland healthcare institutions introducing 140 drug and medical device products listed in Hong Kong and Macau.
The program encompasses 63 drugs and 77 medical devices, benefiting over 17,000 patient visits. This real-world evidence will be crucial for supporting future registration applications and demonstrating product effectiveness in diverse patient populations.
First Research Project Launches with International Partnership
The GBAICTI has already initiated forward-looking planning through a tripartite Memorandum of Understanding signed on September 9 with the LKS Faculty of Medicine of the University of Hong Kong and international biopharmaceutical company GSK. This collaboration represents the institute's first real-world data research project.
The project will begin in Hong Kong and gradually expand to other Greater Bay Area cities including Macau and Shenzhen. Currently in the protocol preparation stage, data collection is expected to officially commence in the second quarter of next year, representing a critical milestone for Hong Kong's emergence as an international hub for real-world studies.
Comprehensive Service Platform Launched
Simultaneously with the RWSAC establishment, the GBA Clinical Trial Collaboration Platform was launched as a unified service portal. The platform integrates Greater Bay Area clinical trial resources and provides a one-stop service entry point for global biomedical enterprises, research and development institutions, and researchers.
The collaboration platform will centrally handle service requests from mainland China and overseas markets, precisely matching suitable research institutions and researchers based on specific needs through the Hong Kong Clinical Trial Digital Portal currently under construction. The platform offers comprehensive expert consultation covering medicine, statistics, regulatory affairs, and ethics review.
Strategic Focus on Advanced Therapies
The GBAICTI will prioritize clinical trials of innovative therapies, with particular focus on rare disease (搜索) drugs, high-end cancer (搜索) drugs, and advanced therapy products including cell and gene therapies. The collaboration platform will serve multiple roles, including acting as a key hub for collecting, storing, and analyzing real-world data while promoting pilot projects.
The platform will also function as an information center to establish a Greater Bay Area clinical research talent pool and provide professional training courses including Good Clinical Practice and advanced therapies. Long-term goals include exploring mutual recognition of ethics reviews through a Shenzhen-Hong Kong collaborative mechanism and regular exchange of review standards to enhance approval efficiency.
Positioning Hong Kong as Global Biomedical Hub
The RWSAC aims to position Hong Kong as a leading region and international hub for real-world studies to attract global collaboration and investment. The center's scope of services includes utilizing real-world data to assess research feasibility and identify suitable research centers for clinical trials, providing comprehensive project management for real-world studies conducted in Hong Kong and other Greater Bay Area cities, and offering expert consultation, professional training, and capacity building.
The initiative leverages Hong Kong's role as a "super connector" with strong mainland support while maintaining close international connections. The GBAICTI will promote the Hetao area as a window for translating innovative biomedical research results globally, attract foreign investment, expedite Greater Bay Area patients' access to advanced treatments, and develop new quality productive forces in the biomedical sector.