Herbal Drugs - What is Well-Established Use?

In the EU, for herbal medicinal products (HMPs), it is possible to replace the results of non-clinical and clinical trials by detailed references to published scientific literature if it can be demonstrated that the active substances of a medicinal product have been in well-established use (WEU) within the EU, for at least 10 years, with recognized efficacy and an acceptable level of safety.

What is needed for the simplified registration and how to demonstrate WEU?

Where the EU (HMPC) herbal monograph refers to WEU, herbal preparations with a specific dosage form will be stated. The applicant therefore will need to demonstrate that the proposed product contains a herbal preparation which is similar to the preparation listed in the monograph. According to the European Medicines Agency (EMA) the applicant would need to address the following:

• Equivalent strength and dosage  
• Same plant species
• Same plant part
• Same extraction solvent with an identical strength
• Same or comparable drug extract ratio (DER)
• Same physical state (e.g. Dry, Liquid (Fluid), Soft extracts)

In addition, HMPs, which have been extensively used for 10 years in an EEA / EFTA State are in principle also eligible for demonstration of WEU. However, according to the agency, the criteria to be taken into account for the demonstration of a WEU under refer also to the quantitative aspects of the use of the substance:

• Extent to which the substance has been used in practice
• Extent of use on a geographical basis
• Extent to which the use of the substance has been monitored by pharmacovigilance or other methods

For more information please see EMA´s Herbal medicinal products: questions and answers.