DH organises Medical Products Regulation Symposium to familiarise trade with timetable and roadmap for Hong Kong's move towards "primary evaluation" of medical products
The Department of Health (DH) and the Hong Kong Science and Technology Parks Corporation (HKSTP) today (February 3) co-organised the Medical Products Regulation (MPR) Symposium to brief representatives from local and mainland regulatory authorities, academia, research institutions and the trade on the timetable and roadmap towards the adoption of "primary evaluation" of medical products in Hong Kong.
The Symposium was held under the theme of "the Future of Medical Products Regulation". The DH highlighted the latest developments in the regulation of medical products in Hong Kong, with a view to promoting research, development and clinical trials, thereby enabling more patients to have earlier access to advanced medical treatments and diagnostics. Representatives from the HKSTP shared the measures to promote medical products innovation, while representatives from the trade introduced the latest developments in the clinical research ecosystem.
Delivering his opening remarks, the Director of Health, Dr Ronald Lam, said, "The year 2026 will mark a significant milestone for the development of innovative drugs and medical device regulations in Hong Kong, China. 'The Chief Executive's 2025 Policy Address' announced that the Government will set up the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026, and implement the 'primary evaluation' mechanism for new drug registration in phases starting from that year, enabling Hong Kong to independently assess and approve the safety and efficacy of medical products based on clinical data, with a view to developing Hong Kong into an internationally recognised authority on medical products regulation. The establishment of the 'primary evaluation' mechanism will help expedite the development of innovative medical products, thereby achieving the goal of making good drugs and medical devices available for use in Hong Kong."
Regarding the phased implementation of "primary evaluation", the initial phases will cover applications for the registration of products containing registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, etc). This will progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in Hong Kong, the Chinese Mainland, and beyond.
"The Government will also submit a legislative proposal on regulating medical devices this year. We encourage the trade to submit applications to list their medical devices under the Medical Device Administrative Control System early, so as to be better prepared for the transition to the future statutory framework," Dr Lam said.
"The DH has been closely monitoring technological developments in innovative medical devices and has issued guidance in a timely manner, such as technical reference documents for the listing of artificial intelligence medical devices, to assist the trade in understanding the relevant requirements. We firmly believe that promoting collaboration among industry, academia and research institutions is of vital importance. To this end, we have stepped up our efforts to communicate and engage with stakeholders, which is also the purpose of this Symposium. We hope that all sectors will work together to lay a solid foundation for Hong Kong's development as an international medical innovation hub, while contributing to our country's efforts to become one of the forerunners in health and medical innovation," Dr Lam added.
This year, with strong support from the National Medical Products Administration, the DH will host the annual meeting of the Global Harmonization Working Party (GHWP). Representatives from global medical device regulatory authorities and industry leaders will gather in Hong Kong, laying the initial foundation for the future role of the CMPR in connecting and establishing a global medical products regulatory system, and even becoming a forerunner in this field.
Additionally, the DH began offering one-on-one pre-new drug application meetings last December for potential applicants for new drugs registration through the "1+" mechanism. Dr Lam urged the pharmaceutical industry to actively apply, working together to achieve the goals of early consultation to enhance quality and efficiency throughout the process so that registration approval can be expedited in Hong Kong, thereby consolidating Hong Kong's position as an international health and medical innovation hub. This service aims to further optimise the new drug registration approval process, and no fees will be charged for this service at this stage.
The Symposium was attended by over 700 participants today. The DH will continue to work closely with different stakeholders to refine regulatory processes and strengthen regional and international collaboration, so as to fully leverage Hong Kong's role as a "super connector" and "super value-adder".
DH organises Medical Products Regulation Symposium to familiarise trade with timetable and roadmap for Hong Kong's move towards "primary evaluation" of medical products Source: HKSAR Government Press Releases
The activation ceremony of Medical Products Regulation Symposium Source: HKSAR Government Press Releases
Dr Ronald Lam, Source: HKSAR Government Press Releases
