Another new drug approved for registration under "1+" mechanism
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Another new drug approved
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The "1+" mechanism has been implemented since November 1, 2023, to facilitate the registration of new drugs used for the treatment of serious or rare diseases in Hong Kong. With effect from November 1, 2024, the "1+" mechanism has been extended to all new drugs, including all new chemical or biological entities, 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).
The above new drug, indicated for chronic spontaneous urticaria, has been approved by the drug regulatory authority in the United States and submitted for registration application under the "1+" mechanism. Having evaluated the clinical data, relevant information submitted by the applicant and advice given by local expert, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong considered that the new drug satisfied the criteria of safety, efficacy and quality, and approved its registration in Hong Kong. The Department of Health (DH) has already notified the applicant of the result of the application.
Chronic spontaneous urticaria is a chronic skin condition that causes unpredictable itch and hives, which can profoundly affect the quality of life. This new drug can provide sustained improvement in symptoms control.
Paving the way towards "primary evaluation"
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Since the implementation of the "1+" mechanism, a total of 22 new drugs, including the above drug, have been approved under this mechanism. 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 realises the concept of "good drugs for use in Hong Kong". Along with the establishment of the Office for Introducing Innovative Drugs and Medical Devices (the Office) on June 8 this year, the HA is collaborating with the 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. The initial phase covers cancer treatments. The evaluation time required for registration in Hong Kong will be shortened from up to 150 working days to no more than 100 working days. This will enable patients to access advanced and effective clinical treatments more promptly.
The 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 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 "1+" mechanism is conducive to enhancing Hong Kong's drug approval capability, and facilitating the development of related hardware, software and human resources, thereby paving the way for the implementation of "primary evaluation". The DH began the phased implementation of "primary evaluation" for new drug registration on March 31, 2026. The initial phase covers applications for the registration of drug products containing locally registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, and etc). The aim is to achieve full coverage of all pharmaceutical products by 2030, which will enable Hong Kong to independently assess and approve the safety and efficacy of new drugs based on clinical data, with a view to expediting the introduction of innovative medical products, thereby achieving the goal of making good drugs and medical devices available for use in Hong Kong for the benefit of patients.
The Chief Executive's 2025 Policy Address announced that the Hong Kong Special Administrative Region (HKSAR) Government will accelerate the reform of the regulatory system of drugs and medical devices, thereby consolidating Hong Kong's position as an international health and medical innovation hub. The DH will establish the Hong Kong Centre for Medical Products Regulation by the end of 2026 to progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in the HKSAR, the Chinese Mainland, and beyond, thereby transforming Hong Kong into an international health and medical innovation hub.
Ends/Monday, August 31, 2026
Issued at HKT 19:48
Issued at HKT 19:48
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