Five‑Year Plan creates Healthcare Innovation System with new drug regulator

The initial phase will begin immediately.

Hong Kong is planning to build a "Healthcare Innovation System" as part of its First Five-Year Plan for Economic and Social Development.

The plan's central regulatory move is the Centre for Medical Products Regulation, which will build an independent approval and oversight mechanism for drugs and medical devices.

Tied to this is a phased rollout of "primary evaluation"— an independent assessment of pre-clinical, clinical, manufacturing, and quality-control data for new drug registrations.

An initial phase begins immediately, with the current voluntary system being replaced by a new statutory regime covering safety, quality and performance.

Additionally, Hong Kong will align with the national measure allowing Hong Kong-registered drugs and devices used in the city's public hospitals to also be used across the Greater Bay Area.

The city will also continue building its proprietary Chinese medicine registration system into a recognised quality brand for export.

On clinical trials, key mechanisms include a Hong Kong Clinical Trials Portal offering smart-matching of researchers and institutions across Hong Kong and the GBA.

This includes an International Clinical Trial Academy providing training under ICH Good Clinical Practice standards, and a Real-World Study and Application Centre that will use local real-world data.