Regulatory Assessment of Reproductive Toxicology Data

This chapter outlines a regulator’s personal approach to the assessment of reproductive toxicology data in the context of the assessment of the overall nonclinical data package for pharmaceutical agents. Using as a framework the International Conference on Harmonisation Common Technical Document headings, guidance is provided on the expectations of regulators for the presentation and discussion of the data by the applicant to facilitate the risk assessment process. Consideration is given to the use of reproductive toxicology data in the assessment process for both clinical trial applications (CTAs) and marketing authorization applications (MAAs). Suggestions for some guiding principles in drafting of the various product information documents (for example the Investigator’s Brochure (IB) for CTAs and the Nonclinical Overview and Summary of Product Characteristics for MAAs) are included.