EMA issues Concept Paper on modern Manufacturing Techniques used for HMPs

The Committee on Herbal Medicinal Products (HMPC) adopted the Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations. The proposed reflection paper should support the industry in the development and application of modern manufacturing methods regarding herbal preparations. The consultation will be open until 15 November 2023.

Background

Traditional methods for the preparation of herbal medicinal products (HMPs) usually involve the use of extraction solvents of different polarities (e.g. ethanol-water mixtures) for the production of extracts for further processing. However, these techniques do not cover all preparations which may currently be available on the market. Modern extraction techniques (e.g. supercritical CO2-extraction) present various advantages over the conventional approaches, such as

• higher extraction efficiency,
• reduction in the use of organic extraction & hazardous solvents,
• reduction in extraction time & consumption of energy,
• extended tools to obtain extracts of selective composition.

However, these methods may also have some disadvantages like issues of

• technical reliability,
• consistency,
• homogeneity,
• stability,
• validation & qualification,
• documentation,
• transferability & scale up.

Moreover, there is a need for guidance to be able to address herbal active substances not obtained with conventional solvent extraction and regarding comparability between preparations obtained by different manufacturing techniques.

Benefits are expected for both, the industry in the preparation of their dossiers and the competent authorities in their assessments. Furthermore, the possibility of including preparations obtained with modern methods in EU herbal monographs is expected to be facilitated. Some existing guidelines or templates may later need to be amended or updated and the considerations may also contribute to the discussion on appropriate HMP manufacturing techniques in coordination with Ph. Eur. expert groups.

The paper invites interested parties to provide relevant information for the development of a new reflection paper. It can be found on EMA's Herbal medicinal products: scientific guidelines website.