The Hong Kong Hospital Authority has established a dedicated Office for Introducing Innovative Drugs and Medical Devices, aiming to reduce drug approval timelines by approximately one-third and bring cutting-edge treatments to public hospital patients faster.
The office commenced operations on June 8, in line with policy directions from the Chief Executive's 2025 Policy Address. Its primary mandate is to significantly expedite the process of introducing new drugs into the Hospital Authority Drug Formulary, while also proactively sourcing innovative medical devices for public hospital use.
Under the new framework, the Hospital Authority will collaborate with the Department of Health to accelerate drug registration through the Priority Review Pathway. The evaluation time for new drugs, initially covering cancer treatment medications, will be reduced from up to 150 working days under the existing mechanism to within 100 working days.
The office will take a proactive approach, reaching out to pharmaceutical companies in mainland China and other regions to understand their drug development timelines. Where suitable drugs are identified, an Assessment Panel comprising clinical specialists, health economists and clinical pharmacologists will evaluate their effectiveness in addressing unmet local medical needs.
Once a drug is confirmed as cost-effective and beneficial to patients, the Hospital Authority will co-ordinate with the relevant pharmaceutical supplier for Hong Kong registration. During the approval process, the office will simultaneously conduct price negotiations and comprehensive assessments to accelerate market entry.
For innovative medical devices, the office has established a dedicated assessment channel to interface with cutting-edge technologies. Manufacturers can submit product information, and the office will guide them through the device listing process with the Department of Health.
The initial phase focuses primarily on cancer treatment drugs, offering patients a wider range of therapeutic options. The Hospital Authority expressed confidence that the new structure will greatly optimise the drug and device introduction process, enabling more innovative treatments to reach public hospital patients promptly.
The initiative positions Hong Kong as a more attractive market for pharmaceutical companies seeking approval in the Asia-Pacific region, while addressing longstanding concerns about the speed of access to new treatments in the public healthcare system.
