A drug monitoring system, also known as a pharmacovigilance system, is a system for detecting, assessing, understanding and preventing adverse drug reactions (ADRs) and other medicine-related problems. For a medicine wholesaler, establishing and maintaining an effective drug monitoring system is part of its licence responsibilities. Although it may be less complex than a manufacturer’s system, a wholesaler’s system should include at least the following: 1) designated staff responsible for receiving and handling ADR reports from customers such as hospitals, pharmacies and doctors; 2) standard operating procedures (SOPs) for recording, assessing and promptly reporting received ADR information to the medicine manufacturer and the Drug Office, Department of Health; 3) the ability to assist manufacturers with medicine recalls; and 4) retention of all relevant records.
HONG KONG DRUG LICENSING
What is a “Drug Surveillance System”? Does a company applying for a wholesale licence need to have one?
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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