Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
Hong Kong pharmaceutical compliance · applications / acquisitions / ongoing maintenance Independent Third-Party Service Provider
HONG KONG DRUG LICENSING

What is my role as a company director throughout the application process? Do I have to participate personally in every step?

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

Q241 · Category E: Application Process and Approval Procedures (Q201-Q250)
As a director of the applicant company, you are ultimately responsible for the entire project and are legally accountable for the success of the application and the company's future compliant operations. Your core role is to make decisions and provide resources. You need to make key decisions, such as approving the budget, selecting the premises and appointing the RP. You must also ensure that sufficient resources are provided to support the establishment of a fully compliant operating system. During the application process, you do not necessarily need to handle every technical detail personally, such as completing forms or drafting SOPs; these tasks may be delegated to professional consultants such as us. However, your involvement is necessary at certain key stages, such as when developing the overall application strategy with us and when reviewing and signing the application documents. In addition, although uncommon, in certain special circumstances the PPB may wish to meet with company directors to understand their commitment to the business and awareness of the importance of compliance.

📘 Regulatory basis

The Companies Ordinance sets out directors’ duties, including the duty to exercise reasonable care, skill and diligence. In the context of medicines regulation, this means directors are responsible for ensuring that the company complies with all relevant laws and regulations, including the Pharmacy and Poisons Ordinance.

📗 Drew Tang's recommendations

We recommend that directors adopt a management approach of “active oversight and professional delegation”. Professional matters should be entrusted to professionals, while a clear reporting mechanism should be established to keep you regularly informed of application progress and any issues encountered. We will provide regular project reports, enabling you to retain full oversight without being burdened by day-to-day details.

📕 Risk notice

The greatest risk is “complete disengagement”. If directors take no interest in the application process and rely entirely on subordinates or consultants, key decisions may be delayed or made incorrectly. More seriously, directors cannot disclaim responsibility by saying they “did not know” if the company commits a serious breach in the course of its operations. The regulator and the courts may hold directors personally liable.

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