The ICH S5(R2) guideline for the testing of medicinal agents

Relying on previous regulatory guidelines from multiple countries, the ICH S5(R2) guideline outlines the preclinical safety studies needed for registration of new medicinal products in the member countries (European Union, Japan, and the United States). The primary purpose of the guideline is to provide a testing strategy to detect and reveal toxicity to the reproductive system including development of the embryo. There are basically three study designs outlined by the guidance, assessment of fertility in adults, pre- and postnatal development of exposed offspring, and morphological evaluation following exposure during major organogenesis. This chapter discusses the major points addressed in the guidance for each study type, and points to additional references that discuss the practical details for conducting such studies.