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In the regulation of proprietary Chinese medicines, what are the main differences from Western medicines in penalties for non-compliance?

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

Q439 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
Although proprietary Chinese medicines and Western medicines are regulated by different bodies (the Chinese Medicine Council of Hong Kong and the Pharmacy and Poisons Board), their regulatory philosophies and penalty principles are similar, with the protection of public health as the primary objective. The main differences lie in the specific legal bases and certain types of non-compliance unique to each. For example, regulation of proprietary Chinese medicines focuses particularly on quality standards for “heavy metals and toxic elements”, “pesticide residues” and “microbial limits”. Breaches of these standards are serious forms of non-compliance specific to proprietary Chinese medicines. Proprietary Chinese medicines are also subject to the issue of “unregistered proprietary Chinese medicines”, similar to “unregistered pharmaceutical products” in the case of Western medicines. In general, penalties for serious offences such as unlicensed operations and the sale of counterfeit or substandard products are severe for both, including substantial fines and imprisonment.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) is the main legal framework for regulating proprietary Chinese medicines, while Western medicines are primarily regulated under the Pharmacy and Poisons Ordinance (Cap. 138).

📗 Drew Tang's recommendations

Whether you deal in Chinese or Western medicines, the core principles of compliance are the same: ensure that products are safe, effective and of controlled quality, and that their sources and destinations are clear and traceable. Our compliance consultancy is tailored to each client's specific business type.

📕 Risk notice

Do not assume that Chinese medicines are subject to more lenient regulation than Western medicines. In recent years, Hong Kong has continued to tighten safety standards and enforcement for proprietary Chinese medicines, particularly in tackling products containing undeclared Western medicine ingredients or excessive levels of heavy metals.

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