The European Medicines Agency's Committee on Herbal Medicinal Products (HMPC) adopted a new European Union herbal monograph on Maydis stigma (corn silk) and revised monographs on Arnicae flos (arnica flower) and Species diureticae (diuretic herbal mixture) during its 130th meeting held 6-8 July 2026, according to a meeting report published by the EMA on 30 July 2026. The finalised monographs, which establish harmonised standards for the safe and effective use of these herbal substances across the EU, will be published on the EMA website along with supporting documents.
The HMPC also decided to initiate revision procedures for monographs on Anisi aetheroleum (anise oil) and Anisi fructus (anise fruit) after detecting new data that could alter their content. The revisions will be added to the committee's work programme. In contrast, systematic reviews of monographs on Salicis cortex (willow bark) and Salviae officinalis folium (sage leaf) concluded that no revision is required, as no new data warranting changes were identified. Review reports for these will be published as addenda to existing assessment reports.
In a move to strengthen pharmacovigilance for herbal products, the HMPC endorsed a draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products (EMA/HMPC/PRAC/301178/2025) for a three-month public consultation until 15 October 2026. The paper, developed jointly with the Pharmacovigilance Risk Assessment Committee (PRAC), aims to clarify how safety signals should be assessed for herbal medicines, which often have less robust clinical data than conventional drugs.
Several assessments are nearing finalisation ahead of the HMPC's September 2026 meeting, including a draft new monograph on Valerianae radix/Passiflorae herba (valerian root and passionflower herb) and a revised monograph on Betulae folium (birch leaf). Reviews of monographs on Myrrha (myrrh), Plantaginis ovatae semen (psyllium seed), and Plantaginis ovatae seminis tegumentum (psyllium seed husk) are also in progress.
The HMPC's work directly impacts manufacturers of herbal medicinal products across the EU, who must comply with the monographs to obtain marketing authorisations or registrations. National competent authorities rely on these harmonised standards to assess product safety and efficacy, while consumers benefit from consistent quality and safety information. The new safety signal reflection paper could impose additional data requirements on industry but aims to improve early detection of risks, balancing public health protection with regulatory burden.