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Hong Kong Advances Health Innovation with New Regulatory and Research Initiatives
Steering Committee reviews progress on medical product regulation, real-world data integration, and clinical trial infrastructure
On June 12, 2025, the Under Secretary for Health, Dr. Libby Lee, chaired the third meeting of the Steering Committee on Health and Medical Innovation Development.
The committee discussed key initiatives aimed at transforming Hong Kong into an international hub for health and medical innovation.
The Department of Health provided updates on the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR).
The CMPR aims to implement a "primary evaluation" approach, allowing direct approval of medical products based on local clinical trial data without relying on other regulatory authorities.
The government plans to announce the timetable for the CMPR's establishment and the roadmap for adopting the primary evaluation system within this month.
The committee also reviewed proposals for the Real-World Study and Application Centre (RWSAC), scheduled for establishment by the end of the year.
The RWSAC will enhance access to health and medical databases and promote collaboration between Hong Kong and Mainland China.
It will integrate real-world data from the use of Hong Kong-registered drugs and medical devices in public hospitals within the Guangdong-Hong Kong-Macao Greater Bay Area.
The objectives include accelerating the research and development, approval, and market launch of innovative medical products; supporting evidence-based decision-making; and establishing Hong Kong as a global hub for real-world studies.
Additionally, the committee examined the progress of the Greater Bay Area International Clinical Trial Institute (GBAICTI), officially established in November 2024 in the Hong Kong Park of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone.
The GBAICTI has been advancing clinical trial projects, strengthening collaboration with local medical schools, and working with the Greater Bay Area International Clinical Trials Center in Shenzhen.
Together, they aim to promote clinical trials and the biomedical industry, as well as establish the GBA Clinical Trial Collaboration Platform.
The Steering Committee, established last year and chaired by the Secretary for Health, comprises members from relevant government bureaux and departments, institutions, and local medical schools.
It is responsible for coordinating and advancing work related to health and medical innovation, aligning with the policy of developing Hong Kong into an international health and medical innovation hub.
The committee discussed key initiatives aimed at transforming Hong Kong into an international hub for health and medical innovation.
The Department of Health provided updates on the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR).
The CMPR aims to implement a "primary evaluation" approach, allowing direct approval of medical products based on local clinical trial data without relying on other regulatory authorities.
The government plans to announce the timetable for the CMPR's establishment and the roadmap for adopting the primary evaluation system within this month.
The committee also reviewed proposals for the Real-World Study and Application Centre (RWSAC), scheduled for establishment by the end of the year.
The RWSAC will enhance access to health and medical databases and promote collaboration between Hong Kong and Mainland China.
It will integrate real-world data from the use of Hong Kong-registered drugs and medical devices in public hospitals within the Guangdong-Hong Kong-Macao Greater Bay Area.
The objectives include accelerating the research and development, approval, and market launch of innovative medical products; supporting evidence-based decision-making; and establishing Hong Kong as a global hub for real-world studies.
Additionally, the committee examined the progress of the Greater Bay Area International Clinical Trial Institute (GBAICTI), officially established in November 2024 in the Hong Kong Park of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone.
The GBAICTI has been advancing clinical trial projects, strengthening collaboration with local medical schools, and working with the Greater Bay Area International Clinical Trials Center in Shenzhen.
Together, they aim to promote clinical trials and the biomedical industry, as well as establish the GBA Clinical Trial Collaboration Platform.
The Steering Committee, established last year and chaired by the Secretary for Health, comprises members from relevant government bureaux and departments, institutions, and local medical schools.
It is responsible for coordinating and advancing work related to health and medical innovation, aligning with the policy of developing Hong Kong into an international health and medical innovation hub.
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