In a major shift from its history of reliance on overseas drug approvals, Hong Kong will start independently reviewing and approving drug products starting from next year. Currently, new drugs can be registered in Hong Kong after being approved by two or more major foreign regulatory bodies and going through a cursory review in Hong Kong. However, the government now wants to transition Hong Kong into its own independent regulatory system in the hope of transforming the city into a medical innovation hub.
Hong Kong’s Department of Health recently published that the Hong Kong Centre for Medical Products Regulation will be set up by the end of 2026, with phased implementation of stand-alone drug review from 2026. The center will become a globally recognized authority by 2030, ultimately dealing with the approval of all new medicines.
Hong Kong will employ a “primary evaluation” policy whereby Hong Kong drug approvals are made based on clinical trial data directly, instead of requiring registration approval elsewhere. This reform will be initiated with low-risk drugs and phased step by step over the course of the next five years. Authorities expect that this strategy will broaden market access and speed up the availability of new drugs in the city.
Approximately 420 members of the existing Department of Health drug and device regulatory staff will be assigned to the new center, as well as 60 specialists and an international expert panel.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.