Hong Kong launched Phase 1 of its new “primary evaluation” regime for drug registration on March 31, 2026. The change supports the creation of the Hong Kong Center for Medical Products Regulation and moves the country closer to a fully independent drug review system by 2030.
Under the new system, the Drug Office can now review some new drug applications without waiting for prior approval from overseas regulators. In Phase 1, this applies only to certain applications for registered chemical products with changes such as new indications, strengths, or dosage forms.
The update also creates three review pathways for pharmaceutical products: primary evaluation, abridged evaluation, and verification. The primary route involves a full review of safety, efficacy, and quality data. The other two pathways still allow reliance on approvals from reference markets in specific cases.
Hong Kong plans to expand the primary evaluation system in stages until it covers all pharmaceutical products.
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.