POLICY EXPRESS · PE-FHB-166 · Food and Health Bureau
Regulating Medical Products: Primary Evaluation
Hong Kong is moving from relying on an overseas regulator to assessing drugs itself, but phase one is narrow and the Centre is not yet in place.
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2 pages · English and 繁體中文 · Built on the 1134211 Framework · Facts as at 25 October 2026
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The tension and our thesis
The tension
Hong Kong is building its own drug assessment and has registered 22 new drugs faster, yet the first phase is narrow, the Centre is not yet in place, and registration does not equal access.
Our thesis
Report the review results, widen scope in steps as capacity allows, and link registration to access.
Three policy problems this brief examines
- 01The first phase is narrow
- 02Capacity and expertise decide speed
- 03Registration is not access
Each problem is developed in three layers: the fact, why it persists, and the consequence for the system.
Three options compared
A · Wait for 2030: keep 1+ as the main route and phase in slowly.
B · Capacity first: recruit experts and strengthen the Department’s review teams.
C · Access first: widen Formulary and Samaritan Fund cover for new drugs.
The scored comparison, the justified recommendation with its phased measures, the implementation challenges, the stakeholder assessment and the success metrics are in the full brief.
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Both pages, in English and Traditional Chinese: the introduction and background, key figures, the three policy problems, the scored options, the recommendation with its phased measures, the implementation challenges, the stakeholder assessment and the conclusion.
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