EMA Updates Draft Guidelines for Herbal Medicinal Product Declarations

On April 1, 2026, the European Medicines Agency released a draft revision of its guideline on declaring herbal substances and preparations in herbal medicinal products (HMPs) and traditional herbal medicinal products (THMPs). The update aims to standardise how herbal ingredients are presented in regulatory submissions and product information, ensuring greater clarity and consistency.

A key focus is the accurate presentation of details in the Summary of Product Characteristics (SmPC), with additional requirements outlined in Annex 1 for labelling and package leaflets.

Among the major updates are revised rules for declaring extracts. Companies will now need to include both the genuine drug-to-extract ratio (DERgenuine) and the corresponding mass of the herbal material in the SmPC. The draft also provides clearer guidance on naming herbal substances, reporting fresh or frozen materials, and specifying solvents, excipients, and combination products.

The draft guideline is open for stakeholder feedback until June 30, 2026.

03-05-2026