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.
The initial phase will begin immediately, with the current voluntary system being replaced by a new statutory regime covering safety, quality, and performance. This move is tied to a phased rollout of “primary evaluation” – an independent assessment of pre-clinical, clinical, manufacturing, and quality-control data for new drug registrations.
Hong Kong will also 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 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.
The Centre for Medical Products Regulation is a central part of Hong Kong’s plan, and it will play a key role in the city’s healthcare innovation system. They will be responsible for building an independent approval and oversight mechanism for drugs and medical devices, which will help to ensure the safety, quality, and performance of these products.
