More and more botanical products are appearing in the market due to the increase in available biotic sources and the sometimes complex effects that occur without visible side-effects. Some herbal medicinal products have a “well-established use” (WEU) with clinical efficacy in specific therapeutic indications. However, even if the botanicals have the intended use of “maintaining health” (botanical products) with or without poor clinical efficiency (“traditional herbal medicinal products” or THMPs), or act as food supplements without any therapeutic function where a safety concern may be suspected, both are deemed to satisfy minimum safety and quality standards.
Sometimes published literature (scientifically accepted and valid toxicological, clinical, epidemiological and post-marketing information) is enough for the bibliographical application of a new candidate. However, these data are often incomplete or unreliable. In such cases, additional non-clinical studies should be conducted (“mixed application”). Even for the traditional herbal medicinal products (for a simplified registration), additional preclinical safety tests may be necessary.
Due to the complexity and diversity of chemicals in herbal products, all experiments are tailor-made and require close collaboration between all parties involved in the safety testing. With our experience in this field, we are able to support you in implementing the most effective development.