Hong Kong

Hong Kong regulates pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138). The Department of Health (DH), through its Drug Office, administers product registration, licensing of importers/wholesalers/manufacturers, and pharmacovigilance. Statutory registration decisions rest with the Pharmacy and Poisons Board of Hong Kong (PPB), an independent statutory body established under the Ordinance. Hong Kong is a reliance jurisdiction. Historically, registration of a new chemical or biological entity required certificates of pharmaceutical product (CPPs) from at least two of 32 recognised reference regulatory authorities (the '2-CPP' requirement). The '1+' mechanism, effective 1 November 2023 (and extended to all new drugs from 1 November 2024), now allows registration with one reference-country approval plus locally evaluated clinical data. The longer-term policy direction — articulated in the 2023 Policy Address — is to evolve toward a primary evaluation regime under a dedicated Hong Kong Centre for Medical Products Regulation. Hong Kong does not operate a centralised national HTA / single-payer reimbursement system. The Hospital Authority (HA) — Hong Kong's principal public hospital provider — manages the HA Drug Formulary, which determines public-sector access to medicines through Drug Utilisation Review Committee (DUC) and Drug Advisory Committee (DAC) decisions. Self-financed and Safety Net items (Samaritan Fund, Community Care Fund) provide subsidised access for high-cost therapies.