Hong Kong to begin independent drug review, approval in 2026

Hong Kong will start reviewing and approving drugs independently in phases next year, while the city’s regulatory agency is set to begin operation by the end of 2026, health authorities have announced, with more new medications expected to hit the local 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.

Ronald Lam (left) and Frank Chan at a press conference to announce the Department of Health’s plan to set up its drug regulatory authority as early as the end of next year. Photo: Edmond So
Ronald Lam (left) and Frank Chan at a press conference to announce the Department of Health’s plan to set up its drug regulatory authority as early as the end of next year. Photo: Edmond So

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.

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