Testing strategies for preclinical safety assessment of herbal medicinal products: considerations for a pragmatic approach

Introduction: Herbs have been the most important source for medicines during the history of mankind. For registration or authorization as herbal medicinal products (HMPs), this long-lasting and widespread use is, besides data on pharmaceutical and safety aspects and, as far as available, on data from systematic studies on efficacy, part of the assessment. Considerations are necessary on how to apply a pragmatic approach to all these aspects. Current situation and outlook: Herbal-specific regulatory guidelines are the core of the regulation in this field. They have to define a framework how to use the gathered an…