When applying for a Hong Kong pharmaceutical licence for medicines manufactured by an OEM in Mainland China, the product information should include detailed product descriptions, manufacturing process flow, GMP certificates, quality control standards, stability data and test reports. All information must meet the Department of Health's requirements and be submitted in Chinese or English. Applicants should ensure that the information is true and accurate, and prepare evidence of the manufacturer's qualifications and contract documents to demonstrate the contract manufacturing relationship. Thorough preparation of the information is key to a successful application.
HONG KONG DRUG LICENSING
How should information on medicines manufactured by Mainland OEMs be prepared for a Hong Kong pharmaceutical licence application?
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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