The Department of Health plans to establish the Hong Kong Centre for Medical Products Regulation by the end of 2026. The centre aims to approve new-drug registrations autonomously by or before 2030.
Li Zili, the centre’s first director, says it must build comprehensive review capabilities through rigorous, science-based decisions and earn international trust. He has argued that Hong Kong should develop its own strengths rather than copy another regulator.
Protecting public health and promoting medical innovation are the centre’s stated mission. Li says serving Hong Kong patients comes first, alongside working with international partners so that medical advances can benefit patients worldwide; the centre could also explore rare diseases and advanced therapies, where regulatory standards are not yet uniform internationally.
Li argues that predictable, transparent and consistent decisions matter more to drug companies than cutting a few dozen days from reviews. He notes that developing a new drug takes at least 10 years, making certainty about regulatory decisions important to the industry.
The Department of Health’s assistant director for drugs said the centre would consider review timelines in other countries, citing about 200 days as the fastest international review period and a reference for Hong Kong. The authorities also plan an interdisciplinary scientific team focused on clinical review.
Li has set himself a 90-day goal of understanding the needs of the team and stakeholders before deciding the centre’s work priorities.