Expanding into international markets requires more than a great herbal product—it demands regulatory compliance
EMA vs FDA: Understanding Regulatory Differences for Herbal Medicines
Expanding into international markets requires more than a great herbal product—it demands regulatory compliance. Two of the most influential authorities in the world of medicine are the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). While both serve to ensure product safety and quality, their approaches to herbal medicine regulation differ significantly. Understanding these differences is essential for herbal startups and pharmaceutical manufacturers seeking global success.
In the U.S., most herbal products are categorized as Dietary Supplements under the Dietary Supplement Health and Education Act (DSHEA). These products are not subject to pre-market approval, and manufacturers are primarily responsible for ensuring their safety.
In contrast, the EMA classifies herbal products under a more structured system:
Traditional Herbal Medicinal Products (THMP)
Well-established Use Herbal Medicinal Products
Each category has its own scientific and historical evidence requirements.
| Regulatory Body | Evidence Focus | Key Requirements |
|---|---|---|
| FDA | Safety only | GRAS ingredients, GMP compliance, accurate labeling |
| EMA | Safety + Efficacy | Minimum 30 years of traditional use (15 years in EU), toxicity studies, quality and manufacturing documentation, sometimes clinical data |
| Pathway | Pros | Cons |
|---|---|---|
| FDA (U.S.) | Faster market entry, lower documentation costs | No therapeutic claims, competitive market |
| EMA (Europe) | Higher credibility, potential classification as a medicinal product | More costly and time-consuming approval process |
Choosing the right regulatory path depends on your target market, available documentation, product type, and business goals. A well-planned regulatory strategy, supported by expert consultation, can save time, reduce risk, and accelerate product launch.
Both the FDA and EMA offer viable but different routes to market for herbal medicines. Startups and herbal product developers must assess which pathway aligns best with their long-term vision. Understanding these frameworks is a powerful step toward building a globally trusted herbal brand.
