Better chemical analysis of herbal medicines needed, says EMA
Analysis of product content should take place throughout entire manufacturing process
The European Medicines Agency (EMA) has called for more detailed analysis of the chemical composition of herbal medicines, so that the presence of contaminants can be measured.
The Agency said 'herbal substances generally have higher contents of micro-organisms when compared with chemically defined drug substances', and stressed that this presents 'particular challenges' to manufacturers given that these contaminants can end up in the final product.
As a result, analysis of product content should be undertaken throughout the entire manufacturing process, said EMA, adding that 'microbiological and mycotoxin contamination cannot merely be controlled by final testing'.
This means that manufacturers need information on the source of a herbal-based substance, knowledge about micro-organisms that may be present, the microbiological purity of excipients, and more.They especially need to know how micro-organisms might alter a herbal medicine’s physicochemical characteristics 'which may lead to detrimental changes to the product’s quality,' said EMA. The Agency noted that manufacturers needed to be able to check the potential chemical degradation of active ingredients derived from a plant, active markers and chemical preservatives. It added: 'Any potential reduction or change in the therapeutic activity of the product must be evaluated.' The presence of bacteria and fungi (yeasts and moulds) are of particular concern, but not viruses.
