Under the “1+” new drug approval mechanism, applicants must submit detailed information on the medicine’s quality, safety and efficacy, giving priority to data already reviewed and approved by internationally recognised regulatory authorities such as the FDA, EMA and PMDA. This includes complete clinical trial reports, pharmacology and toxicology studies, and manufacturing process and quality control documents. Applicants must also provide detailed product information and a risk management plan. The Drug Office, Department of Health emphasises the scientific rigour and transparency of the information to ensure accurate and efficient assessment. The submitted information must be structured in accordance with the Pharmacy and Poisons Ordinance (Cap. 138) and the relevant implementing rules.
HONG KONG DRUG LICENSING
What specific application documentation is required 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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