Hong Kong pharmaceutical licence applications may use existing registration data from Mainland China, but applicants must ensure that the data meets Hong Kong regulatory requirements, including quality standards and safety assessments. As standards differ between the two jurisdictions, some data may need to be adjusted or supplemented, for example, ingredient specifications, excipients and packaging information. Applicants are advised to prepare supplementary information for the Hong Kong market and communicate promptly with the Drug Office, Department of Health, to ensure that the submission is complete and complies with local requirements.
HONG KONG DRUG LICENSING
When applying for a pharmaceutical licence in Hong Kong, how should differences between medicine data and existing mainland registrations be handled?
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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