Hong Kong to begin independent drug review, approval in late 2026
Hong Kong will start reviewing and approving drugs independently in phases when the city's regulatory agency begins operation as early as the end of next year, health authorities have announced, as more new medications are expected to hit the city's market.
The Department of Health on Thursday revealed its plan to set up its drug regulatory authority as part of the city's ambition to become an international hub for health and medical innovation.
The Hong Kong Centre for the Medical Products Regulation, aimed to be a leading international regulatory authority, is slated to be established by the end of 2026.
'With next year's phased implementation of the primary evaluation approach, we hope that there will be more new drugs entering Hong Kong's market,' Director of Health Dr Ronald Lam Man-kin said.
Hong Kong first raised its plan to establish an agency to approve drugs on a 'primary evaluation' approach in Chief Executive John Lee Ka-chiu's 2023 policy address.
Primary evaluation means approving drugs based on their clinical trial data, without relying on registration approval from other regulatory authorities.
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