Hong Kong licence holders should establish a comprehensive supply chain management system and regularly audit and assess Mainland OEM manufacturers to ensure that their GMP systems meet international and Hong Kong standards. Licence holders are advised to enter into detailed quality agreements specifying each party’s responsibilities and quality standards, and to require manufacturers to provide batch production records, test reports and adverse event reports. Regular on-site audits and third-party testing are also effective oversight measures to ensure consistent product quality and compliance.
HONG KONG DRUG LICENSING
How can Hong Kong licence holders oversee the quality management systems of Mainland OEM manufacturers?
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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