Hong Kong will launch its own drug and medical device regulator by late 2026, ending dependence on foreign approvals, Director of Health Ronald Lam Man-kin said on Thursday.

The city will also begin setting up a mechanism for primary evaluation for new drugs in phases in 2026, with the goal of completing the setup in 2030, he added. 

Speaking at a press conference, Lam said the establishment of the Hong Kong Centre for Medical Products Regulation marks a milestone and a critical step toward the long-term goal of implementing primary evaluation.

ALSO READ: Ko: HK healthcare system considered one of the most efficient globally

Primary evaluation will enable Hong Kong to fast-track approval of homegrown drugs and medical devices, breaking off reliance on foreign agencies’ approvals.

Currently, to get registered in the city under the secondary evaluation system, western-style drugs need approval from at least two overseas regulators. Chinese medicines and medical devices are able to get primary evaluation in the city.

At present, some 14,000 pharmaceutical products are registered in Hong Kong, with about 25 percent manufactured locally and 75 percent imported, according to the department.

Lam revealed that since 2023, a total of 11 life-saving drugs, including cancer treatments, were approved to get registered in the city under the interim “1+ mechanism”, which requires only one overseas regulator’s approval for local registration.

READ MORE: New HK healthcare body to develop evidence-based clinical guidelines

In the meantime, the city will file an application for membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in 2027, in a bid to make the city regulatory mechanism internationally-recognized.

Huang Yawen contributed to the story.