On June 8th, the Hong Kong Hospital Authority announced the establishment of the Hong Kong Office for the Introduction of Innovative Drugs and Medical Devices, in line with the policy direction set out in the Chief Executive's 2025 Policy Address.

The new office is now operational and is expected to significantly accelerate the process for bringing "new drugs" and "effective drugs" into the public healthcare system, facilitating their swift inclusion in the Hospital Authority's Drug Formulary. This initiative aims to broadly enhance patient access to superior treatment options.

Furthermore, the office will proactively introduce innovative medical devices that are in the best interest of patients and are cost-effective into public hospitals, with the goal of improving patient outcomes.

A spokesperson stated, "Following the establishment of this office, the Hospital Authority will collaborate with the Department of Health to expedite the registration process for new products recommended by the office through a 'Priority Review Pathway,' thereby speeding up the approval of innovative drugs. For new drugs recommended by the office, initially focusing on cancer treatments, the required review time for Hong Kong registration will be substantially reduced by approximately one-third—from the current maximum of 150 working days under the Department of Health's '1+' mechanism to no more than 100 working days. This will allow patients to access new and effective treatments more quickly, increasing their options."

The office will actively identify local patient needs and the benefits of innovative drug therapies. It will also proactively engage with pharmaceutical companies from the Mainland and other regions to understand their development plans and timelines for new drugs. If suitable drugs for introduction into public hospitals are identified during this process, the office will take the initiative to submit them to a review committee to commence the introduction procedure.

Once a new drug is reviewed and confirmed by the committee to effectively address an unmet local medical need, be cost-effective, and serve patient interests, the Hospital Authority will coordinate with the relevant drug manufacturer to arrange for the drug's registration in Hong Kong.

During the drug registration and approval process, the office will initiate early negotiations with the relevant pharmaceutical companies on drug pricing and conduct comprehensive drug evaluations.

When a new drug is approved for registration in Hong Kong and the Hospital Authority has reached a consensus with the company on price and other requirements, the office will promptly submit an application to the Drug Advisory Committee to include the drug in the formulary for expedited consideration. Suitable drugs will then be incorporated into the Hospital Authority's Drug Formulary for use by patients in need.

The Hospital Authority anticipates that the initial phase will concentrate primarily on introducing cancer treatment drugs, providing patients with more therapeutic choices.

For innovative medical devices that meet local healthcare needs, the office has established a robust and efficient evaluation channel to connect with cutting-edge medical technologies in the market. When manufacturers submit relevant product information, the office will proactively alert them to apply for listing the device in Hong Kong with the Department of Health through a specific pathway, fully accelerating the introduction of suitable innovative medical devices into public hospitals as viable clinical options.

The Hong Kong Hospital Authority expressed confidence that the operational launch of this new office will greatly optimize the process for introducing innovative drugs and medical devices. This is expected to enable faster introduction of more innovative treatments and devices into public hospitals for patient use, thereby enhancing treatment effectiveness and patient welfare.