Hong Kong Department of Health: Hong Kong is moving towards the "first level approval" of medicines and devices, focusing on empowering the responsibilities of the Drug Regulatory Center in the second half of the year.

On April 10th, the Director of the Hong Kong Department of Health, Lu Changmao, stated that Hong Kong is continuing to push forward with reforms to the drug and medical device approval system, moving towards the "first level approval" of drugs and devices. The government plans to submit a draft regulation in the second half of the year, focusing on establishing a Medical Device Regulatory Centre under the Department of Health to give this center clear statutory functions, consolidating its core position in the drug and medical device regulatory system. Lu Changmao mentioned that the country is rapidly developing in innovative drug and medical devices. The "14th Five-Year Plan" and the "15th Five-Year Plan" have repeatedly emphasized accelerating the development of biomedicine and optimizing the evaluation and approval of innovative drugs and clinically needed drugs. The Chief Executive of the Hong Kong Special Administrative Region proposed in the 2023 Policy Address to develop Hong Kong into an international medical innovation hub, reform the approval and registration system for pharmaceuticals in Hong Kong, promote the transformation of innovative pharmaceutical research and development results to align with the national development plan. Hong Kong is moving towards the "first level approval" of drugs and devices and is planning to establish an authoritative international drug and medical device evaluation agency, namely the Hong Kong Drug and Medical Device Regulation Center, hereinafter referred to as the Medical Device Regulatory Center. They are proactively pushing related work, including: (1) In October 2023, with the support of the National Medical Products Administration, Hong Kong became an observer of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to promote the drug regulatory system in Hong Kong. The goal is to become a member of the ICH regulatory agency. It is expected that after the establishment of the Medical Device Regulatory Center, an application will be submitted to the ICH in the second quarter of 2027. (2) In June 2024, the establishment of the Medical Device Regulatory Center, a preparatory office was set up to plan and promote the establishment of the regulatory center. The goal is to establish the Medical Device Regulatory Center within the Department of Health this year and develop it into an international authoritative regulatory body in the field of medical devices in the long term. (3) Since November 2023, Hong Kong has implemented the "1+" new drug approval mechanism, and 19 new drugs have been approved for registration under this mechanism, including seven new drugs that have been approved for inclusion in the Hospital Authority Drug List. This accelerates the introduction of new drugs in Hong Kong, bringing New Hope Liuhe treatments to more patients and paving the way for the implementation of the "first level approval." (4) In March 2026, the first stage of the "first level approval" mechanism for new drug registration was launched, covering the application for registration of extended applications of already registered chemical constituents products (such as new indications, new doses, new methods and doses, and new dosage forms). The mechanism will be expanded according to the published timetable and roadmap, with the goal of fully implementing the "first level approval" for original products by 2030 or earlier. The development of innovative drugs and devices is advancing rapidly. Establishing the Medical Device Regulatory Center and implementing the "first level approval" mechanism will help Hong Kong better leverage the advantages of the "one country, two systems" and promote the introduction and export of innovative biomedicine technologies. The Hong Kong Special Administrative Region must expedite the establishment of a dedicated regulatory agency for medical devices, improve its drug regulatory system, provide the most advanced medical care to its citizens, and align with the national development pace to strive for international discourse power in innovative biomedicine technology.