Hong Kong is taking steps to establish a drug regulatory institution that will permit “first-level approvals,” according to the Chief Executive\u2019s Policy Address for 2023. This initiative means that drug and device market approval filings will be able to secure approval based on clinical data directly, without the need for approvals from other regulatory bodies. The move is expected to attract more drug and device manufacturers to conduct research and development and clinical trials in Hong Kong, establishing capability, legitimacy, and status in different stages to ensure their drug and device approvals are recognized domestically and internationally.<\/p>\n\n\n\n
In 2024, the Hong Kong drug and medical device administration management center preparatory office will be established, and efforts will be made to promote Hong Kong, China’s, participation in the International Conference on Harmonization (ICH) as an observer. The Greater Bay Area international clinical trial institute will be set up in the Hetao Shenzhen-Hong Kong Technology Innovation Cooperation Zone, providing a one-stop clinical trial support platform for pharmaceutical research and development institutions. This will explore the promotion of clinical trial network cooperation with mainland China, particularly the Greater Bay Area, and coordinate clinical trial work between the two regions to meet national and international standards. The Hospital Authority will establish a networked clinical research support office in 2024-2025 to provide consultation and support to frontline staff, introduce measures to encourage medical teams to participate in clinical research and trials, accelerate the ethical approval process for clinical research, and enhance support for clinical research and data sharing systems and mechanisms. A new “1+” mechanism will be established, allowing new drugs for the treatment of severe or rare diseases to be conditionally registered and used in Hong Kong by submitting only one reference drug regulatory agency license approval (such as NMPA) after meeting local clinical data requirements and being recognized by experts.<\/p>\n\n\n\n