Table 3 Marketing authorization vs. simplified registration for herbal medicinal products in the EU
From: Key quality factors for Chinese herbal medicines entering the EU market
Categories | Market authorization for herbal medicinal products (2001/83/EC) | Simplified registration for herbal medicinal products (2004/24 /EC) |
|---|---|---|
Indications | No specific limitations | Limited to self-medication and OTC |
Traditional use evidence | No requirement for stand-alone or mixed application At least 10 years (medicinal use) for well-established use | 30 years outside the EU including 15 years in the EU |
Dosage form | No specific limitations | Limited to oral, external use and inhalation |
Dossier requirements | Pre-clinical (new tests) and clinical data (new trials), or combined with some bibliographic data, Pharmacovigilance | Bibliographic documents, or safety tests, Pharmacovigilance |
Quality control | GACP, GMP and CMC | GACP, GMP and CMC |