TABLE 4.

Proposed quality framework for herbal medicines in FGID (adapted from Holtmann et al ⁸³ )

Domain	Measure
Safety	●Appropriate toxicologic assessment of the plant extracts is done; doses tested should provide an enough safety margin (e.g., doses >100‐fold higher compared to clinically used doses). ●Quality assurance of raw materials: (a) Concentrations of active ingredients and/or lead substances are monitored in raw materials to enable adjustments of production process to ensure consistent product qualities and concentration of active ingredients in the marked product (b) Monitoring of potential contaminations (e.g., heavy metals, mold) ●Appropriate pharmacovigilance of products used in the routine clinical setting consistent with the procedures in place for chemically defined treatment
Efficacy	●In vivo and in vitro studies to explore mechanisms of action of the plant extracts in isolation and in combination ●State‐of‐the‐art clinical trials to proof efficacy regarding relevant outcome parameters (symptom reduction, improvement of QoL) paired with studies on mechanisms
Registration, market access	●Formal registration that mirrors chemically defined products for the respective jurisdictions