The medicine registration process in Hong Kong mainly comprises the following steps: first, prepare a complete application, including the medicine package insert and quality and safety information; next, submit the registration application to the Drug Office, Department of Health, and pay the relevant fees; the Drug Office will then review the information and may conduct an on-site inspection; finally, if the requirements of the Pharmacy and Poisons Ordinance (Cap.138) are met, a pharmaceutical product registration number (such as HK-XXXXX) will be issued, allowing the medicine to be sold in Hong Kong. The process usually takes several months. Applicants should ensure that the information is accurate and complete to avoid delays.
HONG KONG DRUG LICENSING
What are the main steps in the Hong Kong medicine registration application process?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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