A new local drug regulatory body will begin operations by late next year, with Hong Kong set to phase in independent drug approvals from 2026.
The city aims to adopt a “primary evaluation” model, allowing it to green-light medications based on clinical trial data without relying on overseas regulators.
Director of Health Ronald Lam Man-kin said global talent may be needed to support the new review system and the city will seek international recognition for the new body.
New local drug regulator
After a year of preparation, the Hong Kong Centre for Medical Products Regulation (CMPR) is set to be established by the end of 2026.
“The vision of the CMPR is to become a ‘leading, internationally renowned medical products regulatory authority, driving excellence and innovation’, with the goal of gaining international recognition in the field,” Lam outlined.
Assistant Director of Health (Drug) Frank Chan Ling-fung explained that while Hong Kong already conducts primary evaluations for proprietary Chinese medicines and medical devices, Western medicines still undergo secondary evaluation, meaning market approval depends on regulatory decisions from reference countries.
Chan stated that the government will initially take a low-risk, high-safety approach, prioritizing chemical drugs before expanding to biologics, with full coverage of all new drugs expected by 2030.
However, the primary evaluation system will not replace the existing “1+” mechanism or the secondary evaluation approach.
International recruitment may be needed
With the long-term goal to develop the center into an independent agency, authorities acknowledged that they will need more experts, and will not rule out recruiting from overseas.
Currently, the DH has around 420 staff across divisions handling Chinese and Western medicines and medical devices, including inspections, licensing, and approvals. These employees will be reassigned to the CMPR upon its launch.
HK to seek more global recognition in drug regulation
The authority also emphasized that for new drug registrations, Hong Kong needs international recognition. The city has already become an observer of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is drafting a roadmap to achieve full membership, targeting a formal application by 2027.
Lam noted that Singapore took a decade to become a full ICH member but expressed hope that Hong Kong could expedite the process.
(Cheng Wong)
