CHAPTER 3: Regulatory Toxicology for Human Medicines in the European Union

A medicine intended for human use must first be authorised before it can be placed on the market in the European Union (EU). The basis by which these medicines are authorised is on the results of quality, non-clinical and clinical data conducted and submitted by the applicant. This chapter discusses the regulatory toxicology of human medicines. The consideration, in a regulatory context, of all non-clinical data plays an essential role in protecting human health, particularly at the early stages of drug development. Non-clinical data include not only the data on toxicity but also on the primary and secondary pharmacology, safety pharmacology and pharmacokinetics. Ultimately, in order for a medicine to be granted marketing authorisation, the benefit to risk balance, from both clinical and non-clinical data, must be in favour of the medicine.