Another new drug approved under "1+" mechanism
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New drug approved
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The Hong Kong Special Administrative Region (HKSAR) has implemented the "1+" mechanism since November 1, 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 November 1 last year, 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 approval from one reference drug regulatory authority (instead of two in the past).
The above product has been approved by the drug regulatory authority in the United States 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. The Department of Health (DH) has already notified the applicant of the result of the application. The HKSAR Government will also complete the relevant registration processes in accordance with established procedures.
Paving the way towards primary evaluation
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Since the implementation of the "1+" mechanism, a total of 15 new drugs, including the above drug, have been approved under this mechanism. Seven of them have been listed in the Hospital Authority Drug Formulary. The DH has been promoting the "1+" mechanism through different channels and so far has received more than 630 enquiries from over 160 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. Since the launch of the pre-new drug application consultation service in March this year, the DH has already held a number of briefing seminars and workshops. The DH will also have pre-new drug application meetings to be rolled out in the fourth quarter of this year, to enhance the efficiency in processing relevant applications.
"The Chief Executive's 2025 Policy Address" announced that the 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 expedite the "1+" mechanism for new drugs, piloting priority evaluation and approval of innovative drugs as recommended by the Hospital Authority for treatment of severe or rare diseases and to accelerate patients' use of the advanced treatments. The DH will establish the Hong Kong Centre for Medical Products Regulation by the end of next year, and implement "primary evaluation" for new drug registration in phases beginning next year. The DH will continue to proactively advance preparatory work for "primary evaluation" for new drug registration and progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in the HKSAR, the Mainland, and beyond, thereby transforming Hong Kong into an international health and medical innovation hub.
Ends/Friday, October 31, 2025
Issued at HKT 18:35
Issued at HKT 18:35
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