Key points
- A new Priority Review Pathway expedites innovative drugs recommended by the Hospital Authority under the "1+" mechanism, from 8 June 2026.
- For cancer treatments, evaluation time shortens from a maximum of 150 working days to within 100 working days.
- 22 new drugs have been approved under the "1+" mechanism as of 31 August 2026; seven are listed in the Hospital Authority Drug Formulary.
- The mechanism was extended to all new drugs on 1 November 2024.
Priority Review of New Drug Application Recommended by Hospital Authority under "1+" Mechanism
The Office for Introducing Innovative Drugs and Medical Devices ("the Office") was officially established on 8 June 2026 to identify and prioritise innovative drugs from the Chinese Mainland and overseas to address the patients' unmet medical needs and ensure accessibility by patients.
From 8 June 2026, the Department of Health ("DH") will expedite the approval process for innovative drugs recommended by the Office for Introducing Innovative Drugs and Medical Devices of Hospital Authority ("HA") under the "1+" mechanism via "Priority Review Pathway", thereby accelerating the approval of innovative drugs in Hong Kong.
The initial phase covers cancer treatments, for which the evaluation time required for registration in Hong Kong will be shortened from a maximum of 150 working days under the "1+" mechanism to within 100 working days. This will enable patients to access advanced and effective clinical treatments more promptly.
To this end, the DH and HA jointly held a briefing seminar in June 2026. The seminar was well received and was attended by more than 110 representatives, primarily from the regulatory affairs departments of pharmaceutical consultancy companies in Hong Kong.
New Drugs Approved under the "1+" Mechanism
To pave the way for "primary evaluation", the Hong Kong Special Administrative Region (HKSAR) Government first implemented the "1+" drug approval mechanism on 1 November 2023, to facilitate the registration of new drugs used for the treatment of life-threatening or severely debilitating diseases in Hong Kong.
With effect from 1 November 2024, the "1+" mechanism has been extended to all new drugs, including all new chemical or biological entities and new indications, vaccines and advanced therapy products. New drugs that are supported by local clinical data and recognised by local experts can apply for registration in Hong Kong by submitting evidence of approval from one reference drug regulatory authority (instead of two in the past).
Since the implementation of the "1+" mechanism and as of 31 August 2026, a total of 22 new drugs have been approved under this mechanism, bringing more treatment options for patients and facilitating the availability of more good drugs for use in Hong Kong.
Seven of these drugs have been listed in the Hospital Authority (HA) Drug Formulary (HADF). Of these, six have even been listed under the "Special Drug" category of the HADF. If these drugs are prescribed under specified clinical applications, patients are only required to pay the standard fee (i.e. $20 every four weeks). This significantly alleviates patients' financial burden and realizes the concept of "good drugs for use in Hong Kong".
The Department of Health (DH) has been promoting the "1+" mechanism through different channels and has so far received more than 910 enquiries from over 220 pharmaceutical companies, including those from overseas and the Chinese Mainland.
Many companies have expressed interest in submitting applications for registration of their products, including advanced therapy products, under the extended "1+" mechanism. The DH has organised a pre-new drug application consultation service and held a number of briefing seminars and workshops. The DH has also rolled out pre-new drug application meetings to enhance the efficiency in processing relevant applications.
The HKSAR Government continues to strive to accelerate the introduction of innovative drugs and medical devices so that patients can gain early access to advanced diagnoses and treatments, while developing Hong Kong into an international health and medical innovation hub.