Registering Chinese Herbal Products in Global Markets Successfully
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If you're trying to break into global markets with Chinese herbal products, you’re not just selling tradition—you’re navigating a complex web of regulations, cultural perceptions, and scientific scrutiny. As someone who’s helped over 30 brands go international, I’ve seen what works (and what gets rejected at the border).
Why Global Approval Isn’t Just About Quality
Many assume that if their Chinese herbal products are effective and safe, registration in places like the EU, US, or Australia should be straightforward. Wrong. Regulatory bodies don’t assess based on centuries of use—they want clinical data, standardized extracts, and traceable supply chains.
For example, the European Medicines Agency (EMA) treats most herbal products as traditional herbal medicinal products under Directive 2004/24/EC. To qualify, you must prove at least 30 years of traditional use—15 within the EU. The U.S. FDA, meanwhile, regulates these as dietary supplements under DSHEA, meaning no pre-market approval—but also no therapeutic claims without substantial evidence.
Key Markets & Their Requirements (At a Glance)
| Market | Regulatory Body | Product Classification | Minimum Data Required |
|---|---|---|---|
| European Union | EMA / MHRA | Traditional Herbal Registration (THR) | 30 years documented use, safety data, GMP compliance |
| United States | FDA | Dietary Supplement | NDI notification (if new), GMP, labeling compliance |
| Australia | TGA | Listed Medicine (AUST L) | Proof of traditional use, ingredient safety, manufacturing standards |
| Canada | Health Canada | Natural Health Product (NHP) | Monograph compliance or full dossier, clinical rationale |
This table isn’t just for reference—it’s your starting checklist. Missing any of these boxes? That’s likely why your application stalled.
The Hidden Hurdle: Standardization & Testing
One of the biggest reasons applications fail? Inconsistent active compound levels. For instance, Ginkgo biloba extract must contain 24% flavone glycosides and 6% terpene lactones in the EU to be recognized. Without lab-verified consistency across batches, your product won’t pass.
I recommend third-party testing through ISO 17025-accredited labs for:
- Heavy metals (lead, arsenic, cadmium)
- Pesticide residues
- Microbial contamination
- Active marker compounds
Smart Strategy: Start With Australia or Canada
Instead of aiming straight for the EU or U.S., consider entering via Australia’s TGA or Health Canada. Both recognize traditional medicine frameworks and have clearer pathways for herbal products. Success here builds regulatory credibility—and can fast-track approvals elsewhere.
In fact, brands that first register in Canada see a 40% higher approval rate in the EU, simply because their dossiers meet higher evidentiary standards.
Final Tip: Localize Your Messaging
Western regulators respect tradition—but they respond to science. Reframe your product’s story. Instead of saying “used for 2,000 years,” say “supported by 30+ years of ethnopharmacological use and compliant with EMA THR guidelines.” It sounds more credible.
And remember: every successful global launch starts with treating herbal registration not as a formality, but as a strategic process built on data, compliance, and smart positioning.