If the ingredients of a medicine registered in Hong Kong differ from mainland standards, the applicant must submit detailed ingredient information and a safety assessment report to demonstrate that the formulation complies with Hong Kong standards and is safe and effective. Labelling information must be adjusted where necessary to reflect the actual ingredients. The Drug Office will assess the application based on the actual risks and scientific evidence to ensure public safety in the use of medicines. It is advisable to compare the ingredients and prepare comprehensive technical information before applying.
HONG KONG DRUG LICENSING
How should differences between a medicine's ingredients and Mainland Chinese standards be addressed when applying for a Hong Kong pharmaceutical licence?
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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