What ICH M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals requires
ICH M3(R2) sets the framework for nonclinical safety studies required to support human clinical trials and marketing authorisation. The guideline addresses general toxicology, safety pharmacology, genotoxicity, carcinogenicity, reproductive and developmental toxicity, juvenile toxicity, and immunotoxicity, with timing aligned to clinical trial phases. Specific provisions cover microdosing, exploratory clinical trials, and biopharmaceutical exemptions per ICH S6. Compliance is foundational to every IND, CTA, and NDA submission.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf
SHA-256 integrity: 7c30ab849d025d09a1cd2865032a54d629ea7b81efad283065fb220a3374e735
Primary Citations — 5 traced to source
- ICH Harmonised Guideline M3(R2) Nonclinical Safety Studies, June 2009
- ICH S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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