Editorial | New drug approval system takes Hong Kong closer to biomedical hub goal

The ability to independently review and approve drugs will go a long way towards raising the city’s standing as a centre of medical innovation

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Hong Kong will begin reviewing and approving drugs independently in phases from 2026, with a new regulatory system set to begin operating by the end of next year. Photo: Shutterstock

Published: 6:45am, 1 Jul 2025

Hong Kong has good reason to aspire to its own internationally recognised regime for approving pharmaceutical drugs. Intense global demand for Covid-19 vaccines remains fresh in the memory. The city also happens to rank No 2, behind only New York, as a market for biomedical and pharmaceutical companies to raise capital. To realise this goal, developing independent clinical trial capacity and a regulatory framework comparable with the US Food and Drug Administration would go a long way. It would also raise Hong Kong’s standing as a medical innovation hub.

It is therefore good to hear from health authorities that the city will begin reviewing and approving drugs independently in phases from 2026. A new regulatory system is set to begin operating by the end of next year, with more new medications expected to hit the local market before long. To clear the way, the Department of Health has unveiled a plan to set up a centre for the regulation of medical products, with the aim of becoming a recognised international drug regulation authority.

This is the final link in a road map for the development of primary drug evaluation, an approach foreshadowed in Chief Executive John Lee Ka-chiu’s 2023 policy address. This will speed up product reviews. Primary evaluation means approving drugs based on their clinical trial data, without relying on registration approval from other regulatory authorities.

A preparatory office for the centre was set up in June last year to study and plan for a drug regulatory regime. The department said primary evaluation was expected to be implemented gradually over five years. To that end, Hong Kong recently opened its first clinical trial institute, located in a cross-border tech zone.

The development of Hong Kong as a biomedical hub not only means business opportunities for the city, but resonates with vast market potential on the mainland, where people cannot always afford new drugs approved in the US. As a rapidly ageing society, Hong Kong has a multipronged interest in recognition as an Asian pharmaceutical and biomedical hub with big potential for healthcare shaped by biotech and bioscience.

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