Hong Kong to set up drug regulator, experts call for rare disease focus
Hong Kong will establish a drug and medical devices regulator by end of 2026. Experts urge the new agency to prioritise rare disease drug approvals, reduce patient costs, and recruit international talent to speed up reviews.
Hong Kong’s Drug and Medical Devices Regulatory Centre will be set up by the end of 2026, with Li Zili appointed as its director, the government announced.
Penny Peng of the Community Organisation for Social Development said Li’s connections in mainland China and overseas could help the city create an internationally recognised approval mechanism. She hopes the centre will introduce a “first-tier review” system to independently approve new drug registrations, bringing in more oncology and rare disease medicines to ease patients’ financial burden.
Lam Shun-chiu, founder of Hei Wah Pharmaceutical, recommended the centre first focus on approving new drugs for rare diseases. He also urged it to work with international drug regulators to set common standards for emerging fields such as gene therapy and cell therapy. Drug evaluation is a highly specialised field, Lam noted, and the centre should recruit talent from mainland China or abroad, including people who have worked at regulatory agencies or major pharmaceutical firms, to build a cross-disciplinary team and further shorten review times.
Chan Soo-kuen, senior executive director of the Hong Kong Research Pharmaceutical Manufacturers Association, said Hong Kong could act as a super-connector. If the centre can build an efficient and trustworthy evaluation system that serves both local and international markets, it could also help bring innovative drugs from overseas into Hong Kong.