Toxicological assessment compilation of selected examples of raw materials for homeopathic medicinal products

• Published in: Regulatory toxicology and pharmacology 2019-04, Vol.103, p.253-273
• Main Authors: Buchholzer, Marie-Luise, Kirch, Marion, Kirchner, Christiane, Knoess, Werner
• Format: Article
• Language: English
• Subjects: Acceptable amounts per day (AAD); Acceptable/Tolerable daily intake (ADI/TDI); Germany; Homeopathic medicinal products (HMP); Homeopathy - adverse effects; Humans; Lowest Human Recommended Dose (LHRD); Materia Medica - adverse effects; Permitted Daily Exposure (PDE); Risk Assessment; Safety assessment; Threshold of Toxicological Concern (TTC)
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2019.02.007

The considerable number of homeopathic medicinal products (HMP) on the German market and the staggering breadth of active substances of various origin along with the specific legal requirements of adequate safety principles posed the need to compile data on toxicologically evaluated raw materials. In line with the European regulatory framework, HMP applications must consider appropriate safety standards in analogy to conventional human medicinal products. This review presents an option for a systematic and scientifically substantiated approach for regulatory use. Furthermore, this paper provides a multitude of data for selected raw materials processed in HMP with up to now rather scarce knowledge and, thus, aims at filling data gaps on acceptable amounts per day (AAD). The inclusion of raw materials into the compilation was determined considering the frequencies of their occurrence in HMP in Germany along with the availability of appropriate safety assessments. This safety evaluation compilation represents a practical, fairly comprehensive and systematic set of more than 170 raw materials. It is designed to both effectively support regulatory decision making and to be recognized and exploited by applicants, stakeholders and the scientific community. •Homeopathic medicinal products (HMP) applications must consider appropriate safety standards.•The evaluation is building on systematic and scientifically substantiated approaches.•For a multitude of raw materials acceptable amounts per day (AAD) are provided.•The compilation shall support decision making by regulators´, applicants´ and stakeholders´ non-clinical professionals.