If you plan to carry out any pharmaceutical product manufacturing activities in Hong Kong, including manufacture, packaging or labelling, you must apply for a Manufacturer of Pharmaceutical Products Licence (Manufacturer Licence). This is the most stringent and complex of all pharmaceutical licence applications. Your manufacturing premises must strictly comply with Good Manufacturing Practice (GMP) requirements. GMP is an internationally recognised set of mandatory standards for the pharmaceutical industry, covering the entire process from facility design, equipment validation, raw material procurement, production process control, quality testing, to finished product release and distribution. The premises must have separate production areas, storage areas and quality control laboratories, and be equipped with key facilities such as an advanced heating, ventilation and air-conditioning system (HVAC) and a purified water system.
HONG KONG DRUG LICENSING
I want to manufacture medicines in Hong Kong, such as tablets or capsules. Which licence should I apply for, and what are the requirements for the factory premises?
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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