EMA: Scientific guideline: Guideline on repeated dose toxicity

This guideline concerns the conduct of repeated dose toxicity studies of active substances intended for human use. For certain types of substances, such as biotechnology-derived compounds, vaccines and anticancer medicinal products, specific guidance is available (see CPMP/ICH/302/95 Note for guidance on Safety studies for biotechnological products, CPMP/SWP/465/95 Note for guidance on Pre-clinical pharmacological and toxicological testing of vaccines, CPMP/SWP/997/96 Note for guidance on the Preclinical evaluation of anticancer medicinal products). The guideline should be considered also in case of herbal products.