Hospital Authority Launches Office to Fast-Track Innovative Drug Approvals in Hong Kong, Cutting Review Times by One-Third
Key Insights
The Hospital Authority (search) has established the Office for Introducing Innovative Drugs and Medical Devices to expedite patient access to new therapies, commencing operations on June 8, 2026.
A new "priority evaluation pathway" in collaboration with the Department of Health will reduce drug registration review times from 150 working days to no more than 100 working days.
The initial phase will focus primarily on cancer treatment drugs, with the Office proactively engaging pharmaceutical companies in Mainland China and other regions.
The Hospital Authority (search) (HA) announced today the establishment of the Office for Introducing Innovative Drugs and Medical Devices, a new entity designed to significantly accelerate the introduction of novel therapies into Hong Kong's public healthcare system. The Office commenced operations on June 8, 2026, in accordance with the policy direction set out in the Chief Executive's 2025 Policy Address.
The initiative aims to expedite the process of introducing "new and better" drugs into the HA Drug Formulary, thereby comprehensively enhancing treatment options for patients across the public hospital network. In parallel, the Office will proactively introduce innovative medical devices that are cost-effective and beneficial to patients.
Priority Review Pathway Cuts Approval Times
Central to the Office's mandate is a new "priority evaluation pathway," established in collaboration with the Department of Health (DH), which will dramatically shorten the registration timeline for recommended new products. Under the existing "1+" mechanism, the drug registration review process can take up to 150 working days. The new pathway will reduce this timeframe by approximately one-third, capping the evaluation period at no more than 100 working days.
"With the establishment of the Office, the HA will collaborate with the Department of Health 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," an HA spokesperson stated.
Cancer Treatments as Initial Focus
In its first phase, the Office will concentrate primarily on introducing cancer treatment drugs, offering patients a wider range of therapeutic options. The HA spokesperson confirmed that "cancer treatment drugs [will be] covered in the initial phase," underscoring the urgent need to address oncology-related unmet medical needs within the public healthcare system.
Proactive Industry Engagement and Expert Assessment
The Office will take a proactive approach by identifying the needs and potential benefits of innovative drug treatments for local patients and reaching out directly to pharmaceutical companies in Mainland China and other regions to understand their development plans and timelines for new drugs.
When suitable drugs are identified, the Office will refer them to an Assessment Panel comprising experts from various disciplines, including clinical specialists across different specialties, health economists, and clinical pharmacologists. The Panel is tasked with confirming that a new drug effectively addresses unmet local medical needs, is cost-effective, and is beneficial to HA patients. Once these criteria are satisfied, the HA will coordinate with the relevant pharmaceutical supplier to arrange for drug registration in Hong Kong.
Parallel Pricing Negotiations and Formulary Inclusion
During the drug registration and approval process, the Office will commence early negotiations with pharmaceutical companies on drug pricing while simultaneously conducting comprehensive drug assessments. Upon approval of a new drug's registration and reaching consensus on pricing and other requirements, the Office will promptly submit an application to the Drug Advisory Committee for inclusion in the HA Drug Formulary.
Innovative Medical Devices
For innovative medical devices that meet local healthcare needs, the Office has established a dedicated assessment channel to interface with cutting-edge medical technologies. Upon submission of relevant product information by manufacturers, the Office will proactively advise them to apply for device listing in Hong Kong through designated DH pathways, aiming to accelerate the introduction of suitable devices into public hospitals as viable clinical options.
The HA expressed confidence that the launch of the Office will substantially optimize the process for introducing innovative drugs and medical devices, enabling more innovative treatments to reach patients in public hospitals more promptly and enhancing both treatment efficacy and patient well-being.