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

How often should I provide compliance training to my staff to prevent compliance risks?

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

Q450 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
Compliance training should not be a one-off activity, but an ongoing process. We strongly recommend establishing a systematic training programme. First, all new employees should receive comprehensive basic compliance training on joining. Second, all staff should receive comprehensive refresher training at least once a year to reinforce their knowledge and update it. In addition, focused training should be arranged promptly whenever new regulations or company SOPs are introduced or changed. Employees in key roles, such as procurement, quality control and sales, need more frequent and role-specific advanced training. Detailed records of all training should be kept, including the date, content, participants and assessment results.

📘 Regulatory basis

Quality management systems such as Good Distribution Practice (GDP) and GMP expressly require personnel to receive adequate and ongoing training to perform their duties competently.

📗 Drew Tang's recommendations

Treat training as an investment, not a cost. Well-trained staff are your first and most important line of defence against compliance risks. Rengangyongsheng (Hong Kong) Limited can provide clients with tailored annual training plans and course materials.

📕 Risk notice

If a company cannot provide adequate staff training records when a breach occurs, the regulator and the court may well conclude that the company has been systematically negligent in discharging its supervisory and management responsibilities, thereby increasing the penalty imposed on the company.

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