Declaration of Herbal Substances and Herbal Preparations in HMPs

The HMPC issued a concept paper on the revision of the “Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products (HMPs)”.

The document was adopted by HMPC for consultation on January 25, 2023, the start of public consultation was March 1, 2023, and the deadline for comments was May 31, 2023.

Background

The guideline EMA/HMPC/CHMP/CVMP/287539/2005 applies to human and veterinary medicines and was initially published in 2007 and first revised in 2010. It outlines the principles for uniform declaration of herbal substances in HMPs as well as in traditional herbal medicinal products. The declaration is primarily intended to describe the identity and quantity of the herbal drug / herbal drug preparation (e.g. extracts), being the active substance of the HMP.

Examples of declaration of such active substances are provided (e.g., for standardised herbal substances, quantified herbal substances and other herbal substances). The main guideline describes the declaration in the Summary of Product Characteristics (SmPC), including definitions e.g. for Drug extract ratio (DER), Genuine (Native) herbal preparation, Markers, Strength, while package leaflets, labelling and other herbal-specific provisions are provided in Annex 1 to the guideline.

Concept Paper

The published concept paper addresses the reasons why the guideline needs to be revised, stating that although the main principles of the current guideline are still valid, not all aspects and examples reflect the latest state of the art.

Updates and revisions of the specifications of the European Pharmacopoeia (Ph. Eur.) provisions, the HMPC guidelines on the quality of herbal medicinal products as well as experiences from marketing authorisation and registration procedures of HMPs/THMPs are to be considered.

Stakeholders (regulators, pharmaceutical industry, academic groups, and Ph. Eur. expert groups) were initially invited to provide suggestions and examples on this concept paper. While, during the public consultation it was possible to provide specific comments on the draft revised guideline, a summary of the comments will be published together with the final revised guideline.

More detailed information is available in the Concept paper on revision of the “Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal product”’ published on the EMA HMPC website.