Hong Kong will establish its own independent drug and medical device regulatory authority by the end of 2026, marking a transformative shift away from the territory's current dependence on foreign regulatory approvals. Director of Health Ronald Lam Man-kin announced the landmark development on Thursday, describing the establishment of the Hong Kong Centre for Medical Products Regulation as "a milestone and a critical step toward the long-term goal of implementing primary evaluation."
Transition from Secondary to Primary Evaluation
The new regulatory framework represents a fundamental change from Hong Kong's current secondary evaluation system, which requires western-style drugs to obtain approval from at least two of 36 specified overseas regulators before local registration. Under the forthcoming primary evaluation approach, Hong Kong will be able to approve drugs based on clinical trial data without relying on approval from other regulatory authorities.
"Primary evaluation will enable Hong Kong to fast-track approval of homegrown drugs and medical devices, breaking off reliance on foreign agencies' approvals," Lam explained during the press conference.
The transition will be implemented gradually, with primary evaluation beginning in phases from 2026, starting with extended applications of registered chemical drugs. Officials aim to complete the full setup by 2030, establishing a comprehensive five-year implementation timeline.
Current Pharmaceutical Landscape
Hong Kong currently maintains registration for approximately 14,000 pharmaceutical products, with 25 percent manufactured locally and 75 percent imported, according to the Department of Health. The territory has already demonstrated progress toward regulatory independence through its interim "1+" mechanism, which requires approval from only one overseas regulator along with clinical information.
Since 2023, this streamlined approach has facilitated the approval of 11 life-saving drugs, including cancer treatments, for local registration. However, officials could not provide estimates on approval timelines under the new local review system.
Expertise and Global Recruitment
The establishment of the regulatory center will require significant expansion of Hong Kong's current drug evaluation capabilities. Lam noted that approximately 60 professionals currently assist with the vetting process, but acknowledged that substantial additional expertise will be needed.
"With the [centre] coming into being, including internal staff recruitment and also appointment of external experts, we see there is such a need," Lam stated. "We are not ruling out the possibility of global recruitment."
Frank Chan, assistant director of health, emphasized the comprehensive evaluation process required, noting that "pharmaceutical companies have to conduct a number of studies to substantiate a drug's safety first before they can get to the stage of clinical trials."
Legislative Framework and International Recognition
Officials plan to introduce legislation to the Legislative Council next year that will confer statutory authority on the center to regulate medical products. This legal framework will formalize Hong Kong's transition to independent drug regulation.
The territory currently holds observer status at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and plans to apply for full membership in 2027. This step aims to achieve international recognition of Hong Kong's regulatory mechanism and align with global pharmaceutical standards.
Geopolitical Considerations
When questioned about potential national security clauses in the new regulatory regime, Lam indicated that authorities must ensure reduced dependence on certain regions for medical products, reflecting current geopolitical considerations in pharmaceutical supply chains.
The establishment of Hong Kong's independent drug regulatory authority represents a significant step toward pharmaceutical self-sufficiency and positions the territory as a potential regional hub for drug development and approval in Asia.
