The European Medicines Agency (EMA) has released a draft reflection paper outlining specific considerations for detecting safety signals in (traditional) herbal medicinal products, acknowledging that standard pharmacovigilance methods may not be fully applicable to these products. Published on 15 July 2026, the document was jointly developed by the Committee on Herbal Medicinal Products (HMPC) and the Pharmacovigilance Risk Assessment Committee (PRAC), and is open for public consultation until 15 October 2026.
The reflection paper, agreed by PRAC in March 2026 and adopted by HMPC on 8 July 2026, addresses the unique challenges in monitoring the safety of herbal medicines, which often have complex mixtures of active substances, limited clinical trial data, and a long history of traditional use. The document discusses the need for tailored signal detection methods that consider the specific characteristics of these products, such as the potential for interactions with conventional drugs, variability in product composition, and the importance of traditional use data. It also highlights the role of spontaneous reporting systems and the need for enhanced communication with patients and healthcare professionals.
Key stakeholders impacted include manufacturers of herbal medicinal products, who may face additional pharmacovigilance requirements; national competent authorities, which will need to adapt their signal detection processes; healthcare professionals, who will receive more targeted safety information; and patients, who may benefit from improved monitoring of potential risks. The paper does not propose new legislation but aims to provide guidance for consistent safety monitoring across the EU. Following the consultation, the final reflection paper is expected to be adopted by the end of 2026.