Drug Regulators, EMEA, Publish Guidance on Herbal Medicinal Products, Test Materials for Genotoxicity.
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The ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’ is established by the European Commission based on proposals from the Committee on Herbal Medicinal Products (HMPC), in accordance with Directive 2001/83/EC as amended. The list is being developed gradually through entries of structured information relating to individual herbal substances or preparations.
Inclusion in the Community list of a herbal substance/preparation represents a significant advantage to applicants seeking registrations for traditional herbal medicinal products. This is because once a herbal substance/preparation is included in the Community list an applicant will not be required to provide evidence of the safe and traditional use of a medicinal product for which he seeks a traditional use registration if he demonstrates that the proposed product and related claims in the application comply with the information contained in the list.
Once a herbal substance/preparation is included in the Community list, competent authorities will not have the opportunity to require additional data to assess the safety and the traditional use of the product. In view of this, the HMPC has concluded that, where data on genotoxicity are inadequate or absent, it will not be possible to endorse the herbal substance/herbal preparation for inclusion in the Community list.
As a result, progress with the development of Community list is being hampered by the absence of genotoxicity data. Experience to date confirms that many well known traditional herbal substances/preparations, already widely available within the Community, will be excluded from the Community list solely as a consequence of absence of genotoxicity data and thus any potential benefits of the list to applicants will be lost.
To assist applicants, the HMPC has developed a guideline, ‘Guideline on the assessment of genotoxicity of herbal substances/preparations’ (EMEA/HMPC/107079/2007) which describes a general framework and practical approaches on how to assess or to test the potential genotoxicity of herbal substances/preparations and how to interpret the results. The stepwise approach described in the guideline sets out a pragmatic approach to address both scientific aspects of genotoxicity testing and the special needs of herbal medicinal products within the current regulatory framework applicable to these products.
Strictly speaking, genotoxicity testing should be carried out by individual applicants on their specific materials and it is recognised that this represents a major task and considerable duplication of effort particularly for applicants seeking registrations for traditional herbal medicinal products. Industry has therefore been encouraged to consider undertaking collaborative research on genotoxicity and one such study is underway within some Member States.
Community herbal monographs established by the HMPC set out the well-established and/or traditional uses for a particular plant species. The individual monographs usually cover a range of herbal preparations depending on the therapeutic uses of the particular plant. For example, the monographs for Melilot herb and Passiflora herb include a range of preparations as shown in the tables below. This guidance offers a strategy to reduce the number of test materials such that a representative range of herbal preparations is tested rather than requiring individual manufacturers to undertake their own testing on specific preparations.
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