LAUSR

This review aims to highlight recent approaches concerning usage of (traditional) herbal medicinal products in pregnancy and to discuss appropriate strategies to handle limited information. Therefore, published monographs of the Committee on Herbal Medicinal products (HMPC) and selected publicly funded webpages, medicinal handbooks, publications and industry and health care organisations webpages were evaluated. While within the monographs of the HMPC a rather conservative approach could be found (mainly because of lacking nonclinical and/or clinical studies), all other sources display a wide variety of information or assessments, thereby often giving contradictory recommendations. However, some experience with the usage of herbal substances/preparations exists in daily clinical practise without clinical trials or observational studies and some herbal substances/preparations are also used as food/food supplements/cosmetics/medical devices. Discussions should be started how to use that knowledge and experience to adjust regulatory decisions on a case-by-case basis, if possible.