Pharmaceutical/Drug Registration in Hong Kong

Hong Kong's market for pharmaceuticals/drugs is about $1.5 billion. 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 before they can be sold in Hong Kong. Several certifications must be attached 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, applicants must fill out a checklist to be submitted with the forms. There is an application fee and also a fee to get the product registration license.

For more information on pharmaceutical/drug registration in Hong Kong, please see the following PBM publications and/or contact us to discuss your specific needs.