Drug and Medical Device Regulatory Centre Bill Gazetted, First Reading Set for November 25
HK01 · 4 SOURCESabout 12 hours ago3 MIN
Summary
The Hong Kong government gazetted the Drug and Medical Device Regulatory Centre Ordinance Bill on Friday, November 13, 2025, setting the stage for a major overhaul of the city's pharmaceutical and medical device regulatory system. The proposed legislation will establish the Drug and Medical Device Regulatory Centre as a statutory body, unifying regulatory powers currently fragmented across multiple agencies. The bill is scheduled for its first reading in the Legislative Council on November 25. Health Bureau Director Lo Chung-mau emphasized that the reform represents a critical milestone, aligning Hong Kong with national development strategies while leveraging the city's unique position under the "one country, two systems" framework to attract cutting-edge medical products and innovations.
Key Points
- The bill proposes establishing the Drug and Medical Device Regulatory Centre as a legal entity to represent Hong Kong, China in international regulatory affairs and forge formal partnerships with top-tier global regulators
- Regulatory powers currently held by the Hong Kong Pharmacy and Poisons Board, Chinese Medicine Committee, and future medical device functions will be transferred to the Director of Health under a unified framework
- The centre will implement a more proactive drug and medical device review and approval mechanism to bring advanced products to Hong Kong patients faster
- The government aims to achieve "good drugs used in Hong Kong, good devices used in Hong Kong" while supporting the biomedical technology sector and enabling innovative products to "import and export"
- The long-term goal is to develop the regulatory centre into an internationally authoritative body recognized globally, with Hong Kong actively aligning with the nation's "15th Five-Year Plan"
Why It Matters
The consolidation of Hong Kong's fragmented drug and medical device regulatory framework into a single, purpose-built centre signals the government's commitment to becoming a premier destination for medical innovation and clinical research. By streamlining approval processes and seeking international recognition, the reform could significantly reduce the time lag between global medical breakthroughs and their availability to Hong Kong patients, while also attracting biomedical investment and talent to strengthen the city's role as a gateway between mainland China and international markets .
The consolidation of Hong Kong's fragmented drug and medical device regulatory framework into a single, purpose-built centre signals the government's commitment to becoming a premier destination for medical innovation and clinical research. By streamlining approval processes and seeking international recognition, the reform could significantly reduce the time lag between global medical breakthroughs and their availability to Hong Kong patients, while also attracting biomedical investment and talent to strengthen the city's role as a gateway between mainland China and international markets .