“Pharmacovigilance” is a scientific system for monitoring, assessing, understanding and preventing adverse drug reactions (ADRs) and other medicine-related problems. Its aim is to monitor the safety of medicines continuously and ensure that their benefits outweigh their risks. Under Hong Kong’s laws and guidelines, holders of certificates of drug registration and licensed manufacturers and wholesalers are responsible for establishing and maintaining an effective pharmacovigilance system. This includes appointing a qualified drug safety officer; establishing a systematic process for collecting, recording and assessing local and global ADR reports; reporting all serious ADRs occurring in Hong Kong to the Drug Office, Department of Health, as required; and preparing and submitting Periodic Safety Update Reports (PSURs) regularly. These responsibilities ensure that medicines continue to be monitored after they are placed on the market, allowing timely action to be taken if new safety risks are identified.
HONG KONG DRUG LICENSING
What is “Pharmacovigilance”? What responsibilities do pharmaceutical licence holders in Hong Kong have in this area?
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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