Medicines manufactured by Mainland OEMs and exported to Hong Kong must be produced in accordance with GMP standards recognised by Hong Kong. The licence holder should confirm that the manufacturer holds a valid GMP certificate and conduct regular audits. We recommend following the Drug Office’s GMP guidelines and requiring the manufacturer to establish a complete Quality Management System, covering raw material procurement, production control, quality testing and product traceability. The licence holder should retain relevant audit records as evidence of compliance and to ensure that medicine quality meets Hong Kong market requirements.
HONG KONG DRUG LICENSING
How can compliance with Hong Kong GMP standards be ensured when medicines manufactured by Mainland OEMs are exported to Hong Kong?
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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