Hong Kong Pharmaceutical Registration and Approval

Under Hong Kong’s Department of Health (DOH), the Pharmaceuticals Service Department of Health (PSDH) regulates pharmaceuticals/drugs. 

All drugs must be registered with the Pharmacy and Poisons Board prior to being sold in Hong Kong. The registration process requires the attachment of several certifications to the product registration application, including a Free Sales Certificate from the country of origin, the manufacturer’s license, a Good Manufacturing Practice (GMP) certificate, etc. In addition, a completed checklist must be submitted with the applicable registration and application fees.