FDA Drugs (New Approvals & NDA)Original article
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
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Summary
The International Council on Harmonisation issued guidance on M3(R2) nonclinical safety studies for conducting human clinical trials and obtaining marketing authorization for pharmaceuticals. This is a routine regulatory guidance document.
Importance:2/10
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ICHnonclinical safetyM3(R2)pharmaceutical guidanceregulatory harmonization
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Published by FDA Drugs (New Approvals & NDA) on September 9, 2026 7:48 PM