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Approximately how much does it cost to apply for proprietary Chinese medicine registration (pCm)? How does this differ from applying for a licence?

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

Q280 · Category F: Fees, budgeting and financial planning (Q251–Q300)
The fees for applying for “proprietary Chinese medicine registration” (Proprietary Chinese Medicine Registration, pCm) are entirely different from the costs of applying for an operating licence. A licence (such as a wholesale or retail licence) authorises business activities at premises, whereas proprietary Chinese medicine registration is a market authorisation for an individual product. The statutory fee for an application for one proprietary Chinese medicine registration is HKD 9,290. This is only the government fee; the actual cost is much higher. A range of tests and studies must be conducted on the product to demonstrate its safety, quality and efficacy, including, but not limited to, tests for heavy metals and toxic elements, pesticide residues, microbial limits and stability. These tests may cost tens of thousands or even hundreds of thousands of Hong Kong dollars.

📘 Regulatory basis

The Chinese Medicine Ordinance (Cap. 549) requires all proprietary Chinese medicines sold in Hong Kong to be registered with the Chinese Medicines Board under the Chinese Medicine Council of Hong Kong. They may only be marketed after obtaining a Certificate of Registration of Proprietary Chinese Medicine (HKC-XXXXX).

📗 Drew Tang's recommendations

Before deciding whether to apply to register a proprietary Chinese medicine, you must conduct a thorough market assessment and cost-benefit analysis. The investment in research and registration for an individual product must be recoverable through future sales profits. We recommend prioritising products with clear market demand, a distinctive formula or a successful track record in other regions.

📕 Risk notice

The greatest risk is investing heavily in testing and registration costs, only for the application to be refused because the safety or quality data does not meet requirements. Alternatively, even if the product is successfully launched, poor marketing may result in weak sales and prevent recovery of the initial investment. Each product registration is an independent investment decision and requires the same level of prudence.

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