Three other new drugs approved under "1+" mechanism for benefits of good drugs
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Three new drugs approved
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 three products have 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 experts, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong considered that the new drugs satisfied the criteria of safety, efficacy and quality, and approved the registration of the new drugs. The Department of Health (DH) has already notified the applicants of the results of the applications.
Paving the way towards "primary evaluation"
Since the implementation of the "1+" mechanism, a total of 14 new drugs, including the above three drugs, have been approved under this mechanism. Five 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 620 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 consultation service for new drugs applications under the "1+" mechanism 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 with potential "1+" registration applicants, starting from the fourth quarter of this year, to enhance the efficiency in processing relevant applications.
The "1+" mechanism serves to attract more new drugs from different parts of the world seeking approval for registration in Hong Kong, giving patients more choices and further strengthening the local capacity for drug evaluation while enhancing the development of relevant software, hardware and expertise with a view to progressing towards "primary evaluation", i.e. to directly approve applications for registration of drugs and medical devices based on clinical data in Hong Kong, without relying on other drug regulatory authorities.
The Hong Kong Centre for Medical Products Regulation will be established by the end of next year, and the DH will implement "primary evaluation" for new drug registration in phases beginning next year, with full implementation by 2030. The DH will continue to proactively advance preparatory work for "primary evaluation" for new drug registration and progressively establish a robust approval system for medical products, providing strong momentum for the development of healthcare in the HKSAR, the Mainland, and beyond, thereby transforming Hong Kong into an international health and medical innovation hub.
Ends/Thursday, August 28, 2025
Issued at HKT 17:15
Issued at HKT 17:15
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