If a quality issue arises with a medicine manufactured under a cross-border contract manufacturing arrangement, the Hong Kong licence holder should immediately initiate a recall, notify the Department of Health and relevant regulatory departments, and cooperate with the investigation. The licence holder must trace the manufacturing and distribution records for the affected batch, assess the risk and take corresponding corrective measures. At the same time, oversight of the OEM manufacturer should be strengthened, the root cause identified and recurrence prevented. Risk alerts should be issued to consumers promptly to protect public health and the company’s reputation.
HONG KONG DRUG LICENSING
How should a Hong Kong licensee respond if a quality issue arises with a medicine manufactured under cross-border contract manufacturing?
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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