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 and new indications, and vaccines and advanced therapy products. New drugs that are supported by local clinical data and recognised by local experts can be applied 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 metastatic hormone-sensitive prostate cancer, has been approved by the drug regulatory authority on the Chinese Mainland and submitted for registration applications under the "1+" mechanism. Having evaluated the clinical data and 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 the registration of the new drug in Hong Kong. The Department of Health (DH) has already notified the applicant of the result of the application.
Paving the way towards primary evaluation
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Since the implementation of the "1+" mechanism, a total of 23 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, which 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 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 so far has received more than 920 enquiries from over 230 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 held pre-new drug application meetings to enhance 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 from 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, 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 First Five-Year Plan for Economic and Social Development of the Hong Kong Special Administrative Region (2026–2030) and the Chief Executive's 2026 Policy Address announced that the Hong Kong Special Administrative Region (HKSAR) Government will strive to develop Hong Kong into a globally influential international health and medical innovation hub to fully align with the direction set out in the National 15th Five-Year Plan of supporting the development of innovative drugs and medical devices (collectively known as medical products). The Government will continue to comprehensively intensify the regulatory reform of medical products, establish a more proactive evaluation and approval mechanism, and become an internationally renowned authority for medical products, with the aim of enabling the most advanced drugs and medical devices to be introduced into Hong Kong more quickly for the benefit of patients, while attracting more leading international and Mainland biomedical enterprises to invest in Hong Kong. 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/Thursday, October 15, 2026
Issued at HKT 15:40
Issued at HKT 15:40
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