This depends on the nature and scale of the alterations. If renovation or alteration works affect the production process, clean-area layout, air purification system, storage conditions or any important facilities relevant to the Hong Kong Good Manufacturing Practice for Proprietary Chinese Medicines (GMP), you must submit a change application to the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong and obtain approval before commencing work. You will need to submit detailed plans and an explanation of the changes, explaining their purpose and how compliance with GMP will be maintained afterwards. The Chinese Medicines Board will usually arrange an on-site inspection after the work is completed.
HONG KONG DRUG LICENSING
If the factory holding my proprietary Chinese medicine manufacturer licence is undergoing internal renovation or alteration, is prior approval required?
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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