New HMPC Guidelines for Herbal Medicinal Products

GMP News No. 865

GMP News
10 January 2007

New HMPC Guidelines for Herbal Medicinal Products

The Committee on Herbal Medicinal Products (HMPC) of EMEA passed the following two guidelines in September 2006:

  • Guideline on the Assessment of Clinical Safety and Efficacy in the Preparation of Community Herbal Monographs for Well-Established and of Community Herbal Monographs / Entries to the Community List for Traditional Herbal Medicinal Products / Substances / Preparations.
  • It is the task of HMPC to create Community Monographs for "well-established" and for traditional herbal medicinal products. Furthermore, it is supposed to write down a Community list of traditional herbal medicinal products. Here it is important to define the borderline between the "well-established" products with sufficient scientific background on the one hand and the traditional herbal medicinal products used solely on the basis of long-standing experience on the other hand. This new HMPC Guideline explains how the data for "well-established" and for traditional herbal medicinal products should be assessed. For both product groups, there are detailed descriptions of the data on clinical efficacy and safety that have to be handed in.

    The complete document can be found here:

  • Guideline on Non-Clinical Documentation for Herbal Medicinal Products in Applications for Marketing Authorisation (Bibliographical and Mixed Applications) and in Applications for Simplified Registration.
  • This guideline defines the minimum requirements on non-clinical data (e.g. toxicological information) that should be indicated together with bibliographic data when applying for the registration of a "well-established" herbal medicinal product. If these minimum requirements cannot be met by the existing literature, a "mixed application" becomes mandatory, possibly requiring further non-clinical tests. The guideline shows which non-clinical safety aspects have to be addressed in the expert report in case of simplified registration of traditional herbal medicinal products and which non-clinical tests may also be necessary to prove product safety.
    Point 4.3 'Genotoxicity' mentions among other things that the genotoxic potential of herbal preparations should be assessed. If there are not enough data on genotoxicity available, additional genotoxicity tests have to be conducted.

    The complete guideline can be downloaded via the following link:

    Dr Günter Brendelberger
    On behalf of ECA

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