香港卫生署：今年将成为中国香港药械创新监管里程碑 实现“好药港用、好械港用”

Core Viewpoint - The establishment of the "Hong Kong Drug and Medical Device Supervision and Management Center" in 2026 marks a significant milestone for the regulation of drug and medical device innovation in Hong Kong, aiming to enhance the region's status as an international authority in this field [1][2] Group 1: Regulatory Developments - The Hong Kong government will implement a new "first-tier approval" mechanism for drug registration in 2026, allowing for independent evaluation and approval of drug and medical device safety and efficacy based on clinical data [1] - The first phase of the "first-tier approval" will cover registration applications for products with registered chemical elements, including new indications, dosages, and formulations, to gradually establish a comprehensive approval system [1] Group 2: Industry Support and Initiatives - The Hong Kong Department of Health will submit legislative proposals for regulating medical devices this year, encouraging the industry to prepare for the transition to a future statutory framework [1] - A "one-on-one" consultation service for applicants under the "1+" mechanism for new drug registration has been initiated, aiming to optimize the approval process without any fees during the current phase [2] - The Hong Kong Department of Health is closely monitoring the technological developments in innovative medical devices and will issue guidelines to assist the industry in meeting relevant requirements [1][2]