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A draft guideline was published by the EMEA's Committee of Herbal Medicine (EMEA/HMPC/107079/2007, dated 31 October 2007) [18] addressing how genotoxic impurity (GTI) management of herbal medicines should potentially be approached. This proposed a very simple approach – a herbal medicine and its source and manufacturing process should simply be evaluated in genotoxicity studies, and if the material is free of genotoxic response, then the impurity profile needs no further risk assessment. This is despite that for genotoxic tests like the Ames test to be effective in determining the true risk of an impurity being genotoxic there needs to be a particular level of exposure to the impurity in the test (250 μg/plate as a stated recommended threshold). An impurity below this threshold in the test cannot be deemed to be non‐genotoxic if the test comes back without adverse findings. Thus, the acceptance of such an approach as the basis of defining the safety for herbal medicine is different from EU/ICH M7 expectations for synthetically derived pharmaceuticals, where a deeper (and more stringent) evaluation of risk coming from particular impurities is possible and is mandated.