Module 4: Nonclinical Study Reports

Module 4 houses every nonclinical study report that establishes the preclinical safety and pharmacological profile of a drug candidate — from primary pharmacodynamics through comprehensive toxicology. Governed by ICH M3(R2) for timing requirements and ICH S-series guidelines for study design, Module 4 provides the evidence base that regulators evaluate before any human exposure is authorised. Gaps in this module — missing NOAEL justification, absent GLP compliance statements, or incomplete toxicokinetic data — are among the most common reasons for clinical-hold recommendations.