What Changed
- Gazetting of the Centre for Medical Products Regulation Bill on November 13, 2026.
- Transfer of statutory powers over Chinese and Western medicines to the Director of Health to unify regulation.
- Scheduled First Reading of the Bill in the Legislative Council on November 25, 2026.
On November 13, 2026, the Hong Kong SAR Government gazetted the Centre for Medical Products Regulation Bill. The draft legislation aims to establish the statutory status of the Centre for Medical Products Regulation (CMPR) as a body corporate and rationalise the regulatory framework for Chinese medicines, Western medicines, and medical devices. The Bill is scheduled to be introduced into the Legislative Council (LegCo) for First Reading on November 25, 2026.
According to the Secretary for Health, Professor Lo Chung-mau, the initiative comprehensively aligns with mainland China's National 15th Five-Year Plan under the "one country, two systems" principle. The Government intends to establish a proactive evaluation and approval mechanism to accelerate the availability of advanced medical products in Hong Kong SAR and develop the city into an international health and medical innovation hub. The long-term goal is to build the CMPR into an internationally recognised regulatory authority.
The major legislative proposals under the Bill include:
1. Statutory Body Corporate: Establishing the CMPR as a body corporate to represent Hong Kong, China in international regulatory affairs concerning medical products and foster formal working relationships with global regulatory authorities.
2. Unified Regulatory Framework: Transferring existing regulatory powers and functions regarding Chinese and Western medicines—currently exercised by the Pharmacy and Poisons Board of Hong Kong, the Chinese Medicines Board of the Chinese Medicine Council of Hong Kong, and their committees—along with future medical device oversight following legislation, to the Director of Health.
3. Supporting Enhancements: Enhancing supporting mechanisms and enacting necessary technical amendments to expedite the clinical application of innovative medical products while maintaining safety, quality, and efficacy standards.
The Government previously consulted the LegCo Panel on Health Services on the proposals in April 2026 and engaged with stakeholders across the Chinese and Western medicine sectors.
Who May Be Affected
Pharmaceutical companies, medical device manufacturers, Chinese and Western medicine practitioners, biomedicine R&D enterprises, and healthcare institutions in Hong Kong SAR and globally.
Cross-Border Context
Aligns Hong Kong SAR's medical regulatory framework with mainland China's National 15th Five-Year Plan and seeks international recognition from global regulatory authorities.
What to check next
- Track the First Reading of the Bill in LegCo on November 25, 2026.
- Review the full text of the gazetted Bill for specific statutory amendments.
This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.