Hong Kong to submit drug and medical device regulatory bill to LegCo
Hong Kong will table a bill to create a central Drug and Medical Device Regulatory Centre, aiming to streamline approvals, align with national plans, and become an international hub. The bill goes to LegCo on 25 November.
Hong Kong’s government will submit the Drug and Medical Device Regulatory Centre Bill to the Legislative Council for its first reading on 25 November, the Secretary for Health, Professor Lo Chung-mau, announced on 13 November.
The proposed centre, to be established as a corporate body, would represent the Hong Kong Special Administrative Region in international drug and medical device regulatory affairs. It would also build formal, long-term working relationships with high-level global regulators, according to the government.
The bill consolidates regulatory powers now scattered across the Pharmacy Board of Hong Kong, the Chinese Medicine Management Committee and its Chinese Medicine Group, and future medical-device legislation. These functions would be transferred to the Director of Health, creating a unified regulatory framework.
Professor Lo described the centre as “a major milestone in Hong Kong’s drug and device regulatory reform”. He said the government would “comprehensively and proactively align” with the national 15th Five-Year Plan, leveraging Hong Kong’s unique advantages under “one country, two systems” to establish a more proactive review and approval mechanism. This would allow advanced drugs and devices to reach patients faster and help transform Hong Kong into an international medical innovation hub.
“We will continue to deepen co-operation with global regulatory authorities and seek international recognition, with the long-term goal of developing the centre into an internationally authoritative regulator,” Professor Lo added.
The government consulted the Legislative Council’s Health Affairs Committee on the proposed legislation in April and has been in ongoing dialogue with the Chinese and Western medicine industries and other stakeholders.
The bill also includes supporting mechanisms and technical amendments. Professor Lo said the government aimed to “create a world-class and modernised regulatory environment” that ensures safety, quality and efficacy while accelerating clinical use of innovative drugs and devices, supporting biomedical research and helping innovative products “come in and go out”.
