The Guangdong-Hong Kong-Macao Greater Bay Area International Clinical Trial Center has established a new center to support the registration of innovative drugs and medical devices and accelerate research and market launch

The Health Bureau announced that the "Guangdong-Hong Kong-Macao Greater Bay Area International Clinical Trial Institute," established and wholly owned by the Hong Kong government, has officially launched the "Real World Research and Application Center" and simultaneously initiated the "Guangdong-Hong Kong-Macao Greater Bay Area Clinical Trial Collaboration Platform."

The center will leverage Hong Kong's unique medical data advantages to enhance the access and application of health and medical databases, integrating real-world data generated under the "Hong Kong-Macao Drug and Medical Device Pass" policy to support the registration applications of innovative drugs and medical devices in Hong Kong, the mainland, and overseas, accelerating product research and development, approval, and market launch. As of December 10 this year, the "Hong Kong-Macao Drug and Medical Device Pass" has facilitated the introduction of a total of 140 drug and medical device varieties from 71 designated mainland medical institutions, benefiting over 17,000 people.

In addition, the center will actively promote data applications to support evidence-based decision-making, thereby optimizing treatment plans and enhancing the efficiency of the healthcare system, positioning Hong Kong as a leading region and international hub for real-world research, attracting global collaboration and investment. The center's service scope includes using real-world data to assess research feasibility and identify suitable research centers for clinical trials; providing comprehensive one-stop project management for real-world research conducted in Hong Kong and other cities in the Greater Bay Area; and offering expert consultation, professional training, and capacity building in the field of real-world research.

The simultaneously launched collaboration platform is a unified service portal jointly established by "one institute and one center," aimed at integrating clinical trial resources in the Greater Bay Area to provide a one-stop service entry for global biopharmaceutical companies, research institutions, and researchers. The collaboration platform will uniformly handle service requests from both domestic and international sources, accurately matching suitable research institutions and researchers according to specific needs through the developing Hong Kong clinical trial information platform. The platform will also provide comprehensive expert consultation covering pharmacology, statistics, regulatory affairs, and ethical review.

Furthermore, the collaboration platform will play multiple roles, including serving as a primary hub for collecting, storing, and analyzing real-world data and promoting pilot projects; acting as an information center to establish a "Greater Bay Area Clinical Research Talent Reserve," offering professional training courses including "Quality Management Standards for Drug Clinical Trials" and advanced therapies; and in the long term, establishing a collaborative mechanism between Hong Kong and Shenzhen to regularly exchange review standards and explore the possibility of mutual recognition of ethical reviews to enhance approval efficiency