4.2.3.5.3 — Prenatal and Postnatal Development

Pre- and postnatal development study (Segment III) evaluating effects on offspring development

Requirements by Phase

IND Phase 3: required NDA: required

Content Requirements

• Pre- and postnatal development study including maternal function
• Effects on offspring growth, development, behavior, reproductive function
• F1 generation assessments through sexual maturity
• GLP required, rat

Expected Deliverables

• Pre/postnatal development study report (GLP, rat)
• Summary table of maternal and offspring findings

ICH Guidelines: S5(R3)

Regulatory Requirements (ICH M3R2)

• [marketing] The pre-postnatal development study should be submitted for marketing approval in all ICH regions.

Regulatory Requirements (ICH S5R3)

• [All] Vaccination regimen should maximize maternal antibody titers/immune response throughout embryonic, fetal, and early postnatal periods; episodic dosing is recommended for pregnant animals.
• [All] Fetal morphologic abnormalities should be described using industry-harmonized terminology; litter is the unit of analysis for cesarean, fetal, and postnatal data.

Source: ICH S5(R3)