Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

Can non-Hong Kong residents serve as company directors or shareholders when applying for pharmaceutical licences?

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.

Drug Office, Department of Health Chinese Medicines Board

Q102 · Category C: Applicant eligibility and personnel requirements (Q101–Q150)
Yes. Hong Kong’s legal system is open to business investment and does not restrict the nationality of directors or shareholders of a licensed medicines company. Mainland Chinese residents and foreign nationals alike may be directors or shareholders of an applicant company. However, the company must be able to demonstrate substantive management and control in Hong Kong, regardless of the directors’ nationality. In addition, all directors and senior management must meet the ‘Fit and Proper Person’ requirements. This means that they must be of good character, reputation and integrity, have no relevant criminal convictions, and have no history of breaching medicines regulations. The Drug Office will conduct background checks on all key personnel.

📘 Regulatory basis

The Hong Kong Companies Ordinance (Cap. 622) imposes no specific nationality restrictions on directors. However, when considering an application, the Pharmacy and Poisons Board (PPB) will assess the applicant’s fit and proper status in full; this is one of its important discretionary powers.

📗 Drew Tang's recommendations

We recommend that, if the company’s senior management team members are not Hong Kong residents, it appoint at least one director or senior manager resident in Hong Kong to handle day-to-day communications with regulators and ensure local compliance. This helps demonstrate to the Drug Office the company’s commitment to its Hong Kong business and the substance of its local management.

📕 Risk notice

If a company's directors or shareholders have a record of pharmaceutical-related offences in another country, or are under investigation, this must be disclosed proactively at the time of application. If such information is concealed and later discovered, not only may the application be rejected, but the company and the relevant individuals may also be blacklisted, affecting any future licence applications.

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