The Department of Health announced today (25th) that in accordance with the measures announced in the 'Chief Executive's Policy Address 2024', the '1+' approval mechanism will be expanded to all new drugs starting from November 1 this year, including vaccines and advanced therapy products, embodying the concept of 'Global First, Hong Kong Use'. Expanding the '1+' mechanism can attract more new drugs from around the world to register in Hong Kong, giving patients more choices, strengthening local drug approval capabilities, promoting related hardware and talent development, and further moving towards 'first level approval'. The government will innovate the system to support technological innovation, develop Hong Kong into an international hub for medical innovation.

According to the 'Pharmacy and Poisons Ordinance' (Chapter 138), pharmaceutical products must meet safety, efficacy, and quality standards, and be approved and registered by the Pharmacy and Poisons Board of Hong Kong before sale or distribution in Hong Kong. The '1+' mechanism which took effect on November 1 last year, is used for the registration of new drugs for severe or rare diseases. If meeting requirements such as local clinical data support and endorsement of the new drug's indications by local experts, in addition to submitting a registration permit from one (instead of the previous requirement of two) reference regulatory authorities, the new drug can be registered in Hong Kong. The '1+' mechanism will be expanded to apply to all new drug applications from November 1 this year.

The Department of Health has announced the arrangements for expanding the '1+' approval mechanism to all new drugs on its relevant webpage, and has proactively introduced the expansion of the '1+' mechanism and related details to stakeholders (including relevant pharmaceutical industry associations and holders of pharmaceutical product registration certificates). For details, please visit the Department of Health's Pharmaceutical Office webpage. The Department of Health will also provide pre-submission consulting services for '1+' new drug registration applications in the first quarter of 2025 to enhance the efficiency of processing related applications.

Since the implementation of the '1+' mechanism, the Department of Health has received inquiries from over 80 pharmaceutical companies, including overseas and mainland manufacturers. Five new drugs have been approved for registration under this mechanism, including two for treating metastatic colorectal cancer, one for paroxysmal nocturnal hemoglobinuria, and two for treating hypercalcemia in patients with parathyroid cancer and certain types of primary hyperparathyroidism, bringing new hope for patients.

The first two new drugs approved for the treatment of metastatic colorectal cancer under the '1+' mechanism have been included in the Hospital Authority's Drug Formulary's dedicated drug category. Patients prescribed these two drugs for specific clinical uses will receive substantial subsidies for drug costs, only needing to pay the standard fee, greatly reducing their financial burden. The Hospital Authority will encourage drug manufacturers or suppliers to apply for local registration of unregistered drugs that are continuously needed, and continue to closely communicate with the Department of Health in line with the '1+' mechanism.

The 'Policy Address' also announced other measures to expedite the reform of the drug approval system, including proposing a timetable for the establishment of the 'Hong Kong Drug Regulatory Center' and a roadmap towards 'first level approval' in the first half of 2025, as well as formulating drug research and development support strategies and measures.