On February 3, Dr. Lam Man-kin, Director of the Hong Kong Department of Health, stated at a pharmaceutical and medical device regulatory seminar that 2026 will mark a milestone in the development of innovative regulation for pharmaceuticals and medical devices in Hong Kong, China. The 2025 Policy Address announced that the Hong Kong government will establish the "Hong Kong Medicines and Medical Devices Administration Centre" within 2026, and begin the phased implementation of the "Primary Approval" new drug registration mechanism within the same year. This will enable Hong Kong to autonomously assess and approve the safety and efficacy of drugs and devices based on clinical data, positioning it as an internationally recognized authoritative regulatory body for pharmaceuticals and medical devices.
Establishing the "Primary Approval" mechanism can accelerate the development of innovative drugs and devices, achieving the goal of "good drugs for Hong Kong, good devices for Hong Kong." Regarding the phased implementation of "Primary Approval," the Hong Kong Department of Health's initial phase will cover registration applications for products involving extended applications of already registered chemical entities (such as new indications, new dosages, new usage methods, new formulations, etc.). This aims to gradually build a robust approval system, injecting strong momentum into the development of the healthcare industry and market expansion for the Hong Kong Special Administrative Region, the nation, and other regions.
Dr. Lam Man-kin said the Hong Kong government will also submit legislative proposals for regulating medical devices this year, encouraging the industry to list their medical devices on the Medical Device Administrative Control System application form as soon as possible to prepare early for the transition to the future statutory framework. He added that the Hong Kong Department of Health has been closely monitoring technological developments in innovative medical devices and issuing guidelines in a timely manner, such as formulating technical reference documents for the listing of AI medical devices, to help the industry grasp the relevant requirements.
This year, with the strong support of the National Medical Products Administration, the Hong Kong Department of Health will host the annual meeting of the Global Medical Device Regulatory Harmonization Conference. Representatives from global medical device regulatory agencies and industry leaders will gather in Hong Kong, laying a preliminary foundation for the future "Hong Kong Medicines and Medical Devices Administration Centre" to connect with and help establish a global regulatory system for drugs and devices, and even become a frontrunner.
Furthermore, the Hong Kong Department of Health began offering one-on-one meeting consultation services in December last year for those interested in submitting new drug registration applications under the "1+" mechanism. Dr. Lam Man-kin called on the industry to actively apply, working together to achieve the goal of "early consultation, improved quality and efficiency, accelerated registration, good drugs for Hong Kong," thereby consolidating Hong Kong's status as an international hub for medical innovation. This service aims to further optimize the new drug registration and approval process, and no fees will be charged for the service at this stage.