ABSTRACT
The toxicologic pathologist's role in the scientific development of drugs has slowly but progressively evolved, such that the pathologist now plays a central role in drug development efforts. Giant strides toward the scientific development of therapeutic agents occurred in the middle of the twentieth century with the advent of what some have referred to as the antibiotic era. The current regulatory framework in the European Union arose from a harmonization of national drug laws to form the European Medicines Agency in 1995. Utilization of standardized diagnostic criteria and nomenclature, such as the Standardized System of Nomenclature and Diagnostic Criteria guidelines or the International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice hopefully minimizes this confusion. Despite the International Committee of Harmonization process and guidelines, regional differences in requirements for drug development and market authorization still exist.
