Although the “1+” mechanism accelerates the approval process, medicines must still comply strictly with Hong Kong's pharmaceutical regulations after they enter the market. Applicants must establish a comprehensive Risk Management Plan (RMP), submit periodic safety update reports (PSURs), and cooperate with the Drug Office in monitoring and investigating adverse drug reactions. In addition, for new medicines involving rare diseases or biological products, regulators may require post-market clinical studies to continue assessing safety and efficacy. Strict post-market regulation helps ensure public safety in the use of medicines while safeguarding product quality and the company's reputation.
HONG KONG DRUG LICENSING
What special post-market regulatory requirements apply under the “1+” new drug approval mechanism?
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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