Draft guidance on pyrrolizidine alkaloids in homeopathic medicinal products published

The Homeopathic Medicinal Products Working Group (HMPWG), a body operating under the Heads of Medicines Agencies (HMA), has published a draft of new guidance concerning pyrrolizidine alkaloids in homeopathic medicinal products. The draft is now open for public consultation until June 8, 2026.

Pyrrolizidine alkaloids are naturally occurring compounds found in various plant species, some of which have been used as sources for homeopathic preparations. This guidance aims to provide clear regulatory direction on managing the presence of these alkaloids to ensure product safety and quality.

The HMPWG is responsible for developing regulatory guidelines for the manufacturing and quality assurance of homeopathic medicinal products. This initiative is part of an ongoing effort to harmonize and clarify the regulatory landscape for homeopathic products across European member states.

Following the consultation period, feedback will be reviewed to finalize the guidance. The aim is to establish clear standards for the industry and regulatory bodies.