The Greater Bay Area (GBA) International Clinical Trial Institute, established and wholly owned by the Hong Kong Special Administrative Region Government, today officially established the Real-World Study & Application Centre (RWSAC).

The institute also launched the GBA Clinical Trial Collaboration Platform simultaneously.

Making the announcements, the Health Bureau said the two launches mark another significant step forward in promoting the co-ordinated development of the biomedical field in the GBA.

The RWSAC will leverage Hong Kong’s unique advantages in medical data to enhance access to and the application of health and medical databases.

It will also integrate real-world data generated under the special measure of using Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals in the GBA.

Ultimately, the RWSAC aims to support registration applications for innovative drugs and medical devices in Hong Kong, the Mainland and overseas, thereby accelerating product research and development (R&D), approval and market launch.

As of December 10, 71 designated Mainland healthcare institutions under the special measure have introduced a total of 140 drug and medical device products listed in Hong Kong and Macau, comprising 63 drugs and 77 medical devices, benefiting over 17,000 patient visits.

The institute signed a tripartite Memorandum of Understanding with the LKS Faculty of Medicine at the University of Hong Kong, and the international biopharmaceutical company GSK in September this year to launch the institute’s first real-world data research project. It is expected that the project will officially start collecting data in the second quarter of next year.

In addition, the RWSAC will actively promote data application to support evidence-based decision-making, thereby optimising treatment strategies and enhancing healthcare system efficiency, and position Hong Kong as a leading region and international hub for real-world studies to attract global collaboration and investment.

Meanwhile, the simultaneously launched collaboration platform aims to integrate GBA clinical trial resources, and provide a one-stop service entry point for global biomedical enterprises, R&D institutions and researchers.

The collaboration platform will centrally handle service requests from the Mainland and overseas, and precisely match suitable research institutions and researchers based on specific needs through the Hong Kong Clinical Trial Digital Portal currently under construction.

The platform also provides comprehensive expert consultation covering medicine, statistics, regulatory affairs and ethics review, the bureau added.