Hospital Authority establishes Office for Introducing Innovative Drugs and Medical Devices, presenting more and better innovative drugs and medical devices for patient care
The following is issued on behalf of the Hospital Authority:
The Hospital Authority (HA) announced today (June 8) that, in accordance with the policy direction set out in The Chief Executive's 2025 Policy Address, the Office for Introducing Innovative Drugs and Medical Devices (the Office) was set up and commenced operations today. The Office will significantly expedite the process of introducing "new and better" drugs into the HA Drug Formulary, thereby effectively and comprehensively enhancing treatments provided for patients. In addition, the Office will proactively introduce innovative medical devices that are cost-effective and beneficial to HA patients for public hospitals' use to improve patient treatment outcomes.
The Hospital Authority (HA), Photo source: reference image
The HA spokesperson said, "With the establishment of the Office, the HA will collaborate with the Department of Health (DH) to expedite the registration process for new products recommended by the Office via the Priority Review Pathway, thereby accelerating the approval of innovative drugs in Hong Kong. In future, the evaluation time required for registering new drugs recommended by the Office, with cancer treatment drugs covered in the initial phase, will be drastically shortened by approximately one-third. The evaluation process, which currently takes up to 150 working days under the DH's existing '1+' mechanism, will be streamlined to be completed within 100 working days. This will enable patients to access advanced and effective clinical treatments more promptly, ultimately providing them with more therapeutic options."
The Office will proactively identify the needs and potential benefits of innovative drug treatments for patients, and will take the initiative to reach out to pharmaceutical companies on the Mainland and in other regions to understand their schedules and arrangements for developing new drugs. Where suitable drugs for introduction into public hospitals are identified in the process, the Office will take a proactive approach by referring such drugs to the Assessment Panel of the Office to initiate the introduction process. The Assessment Panel comprises experts from various disciplines, including clinical specialists across different specialties, health economists and clinical pharmacologists. Once the Assessment Panel has confirmed that a new drug effectively addresses unmet local medical needs, and is cost-effective and beneficial to HA patients, the HA will co-ordinate with the relevant pharmaceutical supplier to arrange for the registration of the drug in Hong Kong.
During the drug registration and approval process, the Office will commence early negotiations with the relevant pharmaceutical company on drug pricing and conduct comprehensive drug assessments in parallel. Upon approval of a new drug's registration in Hong Kong, and once the HA has reached consensus with the pharmaceutical company on pricing and other requirements, the Office will submit an application to the Drug Advisory Committee as soon as possible for assessment on the inclusion of the new drug in the HA Drug Formulary. Suitable drugs will then be introduced into the Drug Formulary for the benefit of patients in need. The HA expects that the initial phase will focus primarily on the introduction of cancer treatment drugs, offering patients with a wider range of therapeutic options.
For innovative medical devices that meet local healthcare needs, the Office has established a robust and efficient assessment channel to interface with cutting-edge medical technologies available in the market. Upon submission of relevant product information by manufacturers, the Office will proactively remind the manufacturers to apply for a device listing in Hong Kong with the DH through the designated pathway. This dedicated effort aims to accelerate the introduction of suitable innovative medical devices into public hospitals, transforming them into viable and accessible clinical options for patients.
The HA is confident that the commencement of operations of the Office will greatly optimise the process for introducing innovative drugs and medical devices, enabling more innovative drugs and medical devices to be made available to patients in public hospitals more promptly, thereby enhancing treatment efficacy and patient well-being.
For information and details regarding the Office, please visit the HA website.
Photo by Bastille Post
