Two more new drugs approved for registration under "1+" mechanism
A Government spokesman announced today (April 23) that two additional new drugs have been approved for registration under the "1+" drug approval mechanism, bringing the total number of new drugs approved under this mechanism to 21. These drugs, in two different dosages, are used to treat patients with hemophilia A or B, bringing more treatment options. The Government will continue 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 hub for medical innovation.
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Two new drugs approved
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The "1+" mechanism has been implemented since November 1, 2023, to facilitate the registration of new drugs used in the treatment of serious or rare diseases in Hong Kong. With effect from November 1, 2024, the mechanism was extended to cover all new drugs, including new chemical or biological entities, new indications, vaccines, and advanced therapy products. New drugs supported by local clinical data and recognised by local experts may apply for registration in Hong Kong by submitting evidence of approval from one reference drug regulatory authority (instead of two previously required).
The two new drugs mentioned above have been approved by the drug regulatory authority in the United States and submitted for registration under the "1+" mechanism. After evaluating the clinical data and relevant information provided by the applicant, and consulting local experts, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong concluded that the drugs met the required standards of safety, efficacy, and quality, and approved their registration in Hong Kong. The Department of Health (DH) has notified the applicant of the approval result.
Paving the way towards primary evaluation
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Since the implementation of the "1+" mechanism, a total of 21 new drugs, including the two mentioned above, have been approved. Seven of these drugs have been listed in the Hospital Authority Drug Formulary (HADF), including two for cancer, one for haematological disease, two for hypercalcaemia, and two for anaemia caused by chronic kidney disease. Of these, six have been listed under the Special Drug" category of the HADF. When prescribed under specified clinical indications, patients are only required to pay the standard fee (i.e. $20 every four weeks), significantly reducing their financial burden and realising the concept of "good drugs for use in Hong Kong".
The DH has actively promoted the "1+" mechanism through various channels and has so far received more than 804 enquiries from over 207 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 expanded "1+" mechanism. Since the launch of the pre-application consultation service in March last year, the DH has organised multiple briefing seminars and workshops, and introduced pre-application meetings in December last year to improve efficiency in processing applications.
The "1+" mechanism strengthens Hong Kong's drug approval capability and supports the development of related software, hardware and talent, 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 drugs containing chemical entities already registered in Hong Kong, with extended applications such as new indications, new strengths, new posology, new dosages forms. The goal is to achieve full coverage of all pharmaceutical products by 2030, enabling Hong Kong to independently assess and approve the safety and efficacy of new drugs based on clinical data, thereby expediting the introduction of innovative medical products and realising the vision of "good drugs and medical devices for use in Hong Kong", benefitting patients.
The Chief Executive's 2025 Policy Address announced that the Government will accelerate reforms to the regulatory system for drugs and medical devices, consolidating Hong Kong's position as an international hub for medical innovation. The DH will expedite the "1+" mechanism for new drugs, piloting priority evaluation and approval of innovative drugs recommended by the Hospital Authority for the treatment of severe or rare diseases, thereby accelerating patient access to advanced therapies. By the end of 2026, the DH will establish the Hong Kong Centre for Medical Products Regulation to progressively build a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in Hong Kong, the Mainland, and beyond, transforming Hong Kong into an international hub for medical innovation.
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