ESCOP, EMA, and HMPC: European Regulatory Frameworks
Current regulatory systems for herbal medicines in Europe
ESCOP, EMA, and HMPC: European Regulatory Frameworks
ESCOP (European Scientific Cooperative on Phytotherapy)
ESCOP, founded in 1989, is an independent scientific organization that develops monographs on herbal medicinal products based on scientific evidence.
ESCOP Monographs
- Based on peer-reviewed literature
- Assess safety, efficacy, and quality
- Provide guidance for regulatory approval
EMA (European Medicines Agency)
The EMA is responsible for coordinating pharmaceutical and herbal medicine approval across the European Union.
HMPC (Herbal Medicinal Products Committee)
The HMPC, established in 2004, is a committee of EMA responsible for evaluating and approving herbal medicines.
Two Pathways
- Well-Established Use - For products with at least 30 years of documented use
- Traditional Use - For products with at least 30 years of traditional use (7 years in EU)
Modern Standards
These frameworks ensure that herbal medicines meeting European standards have:
- Documented safety profiles
- Evidence of efficacy
- Quality and purity specifications
- Consistent labeling and dosage information