11 September 2023

EMA issues Concept Paper on Modern Manufacturing Techniques used for Herbal Medicinal Preparations

The Committee on Herbal Medicinal Products (HMPC) published a new Concept Paper on August 17, 2023, regarding the development of a reflection paper on modern manufacturing techniques used for herbal preparations. The draft version is open to consultation until November 15, 2023.


Conventional techniques in the manufacturing of herbal preparations involve the use of extraction solvents of different polarities such as ethanol-water mixtures, to obtain extracts for further processing. Modern technologies for plant extraction are not yet widely used at industrial level for the production of HMPs and as a result, they are rarely the subject of applications for marketing authorisation/registration or herbal-specific guidance. The new manufacturing processes include modified extraction methods such as ultrasound-assisted, microwave-assisted, enzymatic-assisted, pulsed electric field, supercritical or subcritical fluid and deep eutectic extraction.


New techniques offer various advantages over conventional approaches, including:

  • Higher extraction efficiency
  • Reduction in the use of organic extraction solvents
  • Usage of non-hazardous solvents,
  • Reduction in extraction time
  • Reduced energy consumption
  • Expanded capabilities to obtain extracts with selective compositions (targeted extraction or exclusion of specific fractions from the total spectrum of plant compounds).

In addition to their advantages, these methods may also have some disadvantages related to various technical issues, such as reliability, consistency, homogeneity, stability, validation, qualification, documentation, transferability, or scale up.


The emergence of modern manufacturing techniques may impact the content of quality dossier and assessment requirements for HMPs, including aspects of the comparability of herbal preparations.


The proposed reflection paper should therefore support both the preparation of dossiers and competent authorities in their assessments, as well as the industry in the development and application of modern manufacturing techniques for herbal preparations.