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As a licensed wholesale dealer in Chinese herbal medicines, are we required to comply with Good Distribution Practice (GDP)?

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

Q370 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
Although the “Good Distribution Practice” (GDP) currently required by Hong Kong legislation primarily concerns the Code of Practice for Pharmaceutical Wholesalers for western medicine wholesalers, its core principles are equally important in protecting the quality of Chinese herbal medicines during storage and distribution, and are regarded by regulators as best practice. Chinese herbal medicines are also exposed to risks from changes in temperature and humidity, insect infestation, mould and cross-contamination. Accordingly, as a responsible Chinese herbal medicine wholesaler, you should voluntarily adopt and implement core GDP principles. These include establishing a quality management system; ensuring staff are appropriately qualified and trained; maintaining compliant storage facilities, such as adequate ventilation and protection against damp and pests; applying effective inventory management, such as first in, first out; keeping complete purchase and sales records for traceability; and establishing procedures for handling complaints and returns.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) does not currently require wholesalers of Chinese herbal medicines to obtain GDP certification. However, the Practice Guidelines for Retailers and Wholesalers of Chinese Herbal Medicines issued by the Chinese Medicine Council of Hong Kong contain many requirements consistent with GDP principles.

📗 Drew Tang's recommendations

We strongly recommend that Chinese herbal medicine wholesalers proactively adopt GDP. This can significantly improve the quality of your herbal medicines and operational efficiency, reduce risks, and give you an important competitive advantage by demonstrating your professionalism and reliability to upstream suppliers and downstream customers. You can use the GDP guidelines for Western medicines as a model, adapting them as appropriate to the characteristics of Chinese herbal medicines to establish a QMS suited to your business. Rengangyongsheng (Hong Kong) Limited can provide related consultancy and system development services.

📕 Risk notice

Although it is not mandatory, you may still be legally and commercially liable if Chinese herbal medicines you distribute develop quality problems, such as mould or contamination, due to improper storage or transport. As industry standards continue to rise, extending GDP requirements to Chinese herbal medicines is an increasingly likely trend. Responding only after the change takes effect will be much more costly and difficult.

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