Clinical study data on the safety of isopropanolic extract of Cimicifuga racemosa allow for its unlimited use according to ICH-E1

The duration of use of medicinal products intended for non-life-threatening diseases is directly linked to a positive risk/benefit assessment based on clinical data over distinct exposure periods according ICH-E1 [1]. The HMPC monograph on Cimicifuga racemosa (CR) addressing ethanolic and isopropanolic extract of CR [2] states “Cimicifuga should not be taken for more than 6 months without medical advice”. Based on the ICH-E1-criteria, sufficient clinical study data are available to fulfill the ICH-E1-requirements for a safe long-term treatment – i.e. longer than 6 months – at least for the isopropanolic extract…