The Greater Bay Area (GBA) International Clinical Trial Institute, owned by the Hong Kong government, has officially established the Real-World Study and Application Centre (RWSAC), and simultaneously launched the GBA Clinical Trial Collaboration Platform.
This marks another significant step forward in promoting the co-ordinated development of the biomedical field in the GBA, following the simultaneous establishment of the GBAICTI and the GBA International Clinical Trials Center in Shenzhen under the "one institute, one center" model last year.
The Health Bureau said the RWSAC will leverage the city’s unique advantages in medical data to enhance access to and the application of health and medical databases.
It also said that the centre will integrate real-world data generated under the special measure of using Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals.
The bureau pointed out that the RWSAC aimed to support registration applications for innovative drugs and medical devices in Hong Kong, the Mainland, and overseas, thereby speeding up product research and development, 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 authorities also said the simultaneously launched collaboration platform will handle service requests from the Mainland and overseas and match suitable research institutions and researchers through the Hong Kong Clinical Trial Digital Portal currently under construction.
The platform will also provide comprehensive expert consultation covering medicine, statistics, regulatory affairs, and ethics review, the bureau added.
