Three other new drugs approved for registration under "1+" mechanism
A Government spokesman announced today (February 27) that three more new drugs have been approved for registration under the "1+" drug approval mechanism, bringing the total number of new drugs approved for registration under this mechanism to 19. These three new drugs are used respectively to treat patients with type 2 diabetes mellitus, chronic obstructive pulmonary disease and unresectable or metastatic non-small cell lung cancer, bringing more treatment options to patients. The Government continues to strive 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 health and medical innovation hub.
Three new drugs approved
--------------------------------
The "1+" mechanism has been implemented 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, 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 abovenew drug used to treat type 2 diabetes mellitus has been approved by the National Medical Products Administration, while the other two have been approved by the regulatory authority of the United States and submitted for registration applications under the "1+" mechanism. Having evaluated the clinical data and relevant information submitted by the applicants 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 their applications.
Paving the way towards primary evaluation
------------------------------------------------
Since the implementation of the "1+" mechanism, a total of 19 new drugs, including the above three drugs, 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 has so far received more than 770 enquiries from around 200 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 last year, the DH has already held a number of briefing seminars and workshops. The DH has also rolled out pre-new drug application meetings since December last year to enhance 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 2026, and implement "primary evaluation" for new drug registration in phases beginning in 2026. 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.
Source: AI-found images
