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Hong Kong to begin independent drug review, approval in 2026

Department of Health reveals plan to set up own drug regulatory authority as early as end of next year, in effort to make city a medical innovation hub

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Authorities have said they aim to independently approve all new drugs by 2030. Photo: Shutterstock

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

The Department of Health unveiled its plan on Thursday to set up a drug regulatory authority as part of the city’s ambitions to become an international hub for medical innovation.

The Hong Kong Centre for Medical Products Regulation is expected to be established by the end of next year, with the aim of becoming a leading international regulatory authority.

Shortly before the centre is established, Hong Kong will also start reviewing drugs on its own from next year.

“We have established the road map for primary evaluation, which will be implemented in phases next year and speed up the time in drug review,” Director of Health Dr Ronald Lam Man-kin said.

“We hope that there will be more new drugs entering Hong Kong’s market because of the primary evaluation.”

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