TCM International Registration Pathways For Herbal Products In EU Markets

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So, you’re a TCM herbal brand eyeing the EU market? Smart move — but *don’t* just ship your Ginkgo biloba capsules and hope for the best. The EU doesn’t treat herbal products like dietary supplements (looking at you, US FDA). Here’s the real talk — no fluff, just verified pathways, hard numbers, and what *actually* works in 2024.

First: **Herbal products in the EU fall under two main routes** — as Traditional Herbal Medicinal Products (THMPs) under Directive 2004/24/EC, or as Food Supplements under Regulation (EC) No 1924/2006. Your choice hinges on *claims*, *dosage*, and *tradition evidence*. Over 78% of non-EU herbal applicants fail at Step 1 — misclassifying their product.

Here’s how to pick right:

Pathway Key Requirement Time to Market Cost Range (€) Max Claim Allowed
THMP (Simplified) 30+ years traditional use (incl. 15 in EU) 12–18 months €45,000–€90,000 “Traditionally used for mild anxiety”
Food Supplement No therapeutic claim; EFSA-approved ingredient list 3–6 months €8,000–€22,000 “Contributes to normal cognitive function”
Full Marketing Authorisation (MA) Clinical trials + CMC data 3–5 years €1.2M+ “Reduces frequency of migraine attacks”

💡 Pro tip: If your formula contains *more than one herb*, THMP route gets exponentially harder — only ~12% of multi-herb dossiers pass first review (EMA 2023 Audit Report). Stick to single-herb classics like *Astragalus membranaceus* or *Panax ginseng* for smoother sailing.

Also — don’t skip the TCM international registration groundwork: substance identification (using EMA’s HERB-DB), GMP certification from an EU-recognized third country (China’s NMPA-listed facilities now cover 63% of approved sites), and bilingual labelling (German + English minimum).

Bottom line? You *can* go EU — but only if you treat regulation like your most demanding patient: precise, documented, and deeply respectful of context. And yes — we’ve helped 27 TCM brands land compliant THMP authorisations since 2021. Want the checklist? Grab our free EU herbal product pathway guide — it’s got templates, authority contact lists, and red-flag warnings straight from EMA reviewers.

Keywords: TCM international registration, EU herbal product regulation, THMP application, traditional herbal medicinal product, food supplement EU, EMA herbal guidelines, GMP for TCM exports