Hong Kong Healthcare Drug System

Hong Kong has recently introduced its new 1+ drug approval system, a reform designed to accelerate the registration process and reduce the time it takes to bring new medical treatments to market.

Under the 1+ system, the approval timeline will be reduced from 24 months to just 7 months.  The new framework simplifies the registration process by requiring only a registration and free-sale certificate from one of 36 reference drug regulatory authorities, including the U.S. FDA approved drugs. This eliminates the previous requirement for secondary evaluations from multiple jurisdictions.

Also, in a major shift, the Hong Kong Hospital Authority (HA), which oversees most of the city’s public healthcare facilities, has started accepting direct applications from pharmaceutical companies for new treatments. The HA manages over 43 public hospitals and more than 70 specialist outpatient clinics, serving more than 90% of Hong Kong’s population. With this new approach, the HA is able to bypass the earlier two-tier assessment process managed by the Drug Office, enabling new drugs to independently move from review to launch in as little as five months.

This overhaul is expected to make Hong Kong an even more attractive market for international pharmaceutical companies, while benefiting patients who will gain quicker, more affordable access to innovative therapies. For example, a well-known U.S. pharmaceutical company recently received approval to begin selling its weight-loss drug in Hong Kong by the end of 2024.

Looking ahead, the Hong Kong government plans to establish its own drug approval authority within the next 8-10 years, further enhancing its autonomy in the drug registration process. Over time, this primary evaluation system will also help position Hong Kong as an emerging hub for clinical trials.

For U.S. companies, this regulatory reform ushers in new opportunities for clinical trials, faster market access, and the potential for significant cost savings in bringing treatments to Hong Kong and the broader region.

To learn more about how your company can benefit from Hong Kong’s evolving regulatory landscape, please contact us at Office.HongKong@trade.gov.