Hong Kong medicine registration focuses on medicine quality, safety and labelling compliance. The process is relatively straightforward and does not require clinical trial data to have been generated locally. By contrast, registration of medicines in Mainland China under the Measures for the Administration of Drug Registration is more complex, requiring rigorous clinical trials and consistency evaluations, with longer approval times. Hong Kong focuses on regulation under the Pharmacy and Poisons Ordinance (Cap.138), with an emphasis on post-market oversight, whereas Mainland China has strict pre-market approval by the National Medical Products Administration. The requirements for registration information and approval procedures differ significantly between the two jurisdictions, so businesses need to prepare accordingly.
HONG KONG DRUG LICENSING
What are the key differences between medicine registration in Hong Kong and Mainland China?
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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