EMA/HMPC Reflection Paper on Extracts Purification

On the 16th of September 2010, the EMA published the HMPC document 186645/2008 entitled "Reflection Paper on the Level of Purification of Extracts to be Considered as Herbal Preparations".

The point is that during the different levels of extracts purification, 2 types of extracts can occur:  "herbal preparations" which are recognised by the European Definitions for herbal medicinal products and other extracts which - after further purification steps - are classified as isolated herbal constituents. Those can't be considered as "herbal preparations".

The final decision about the extracts is a case-by-case decision. The goal of this Reflection Paper is to explain which already existing Guidances are applicable to the different extract types and to clarify them to the applicant.

For the assessment, four points have to be considered:

  • Level of refinement 
  • Presence of concomitant constituents
  • Methods of extraction / refining 
  • Examples of categories of preparation of herbal origin

The conclusions define two criteria for non-herbal preparations:

1. Extracts subjected to further chemical processes comparable to a partial synthesis (those preparations must be assessed case by case).
2. Extracts enriched with isolated compounds. 

Annex 1 of this Reflection Paper lists six examples of extracts which are recognised as "herbal preparations" as well as three examples of non-herbal preparations and one borderline case.

You can find the complete document here.

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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