ICH Guidelines
ICH M3(R2) - Nonclinical Safety Studies for Clinical Trials and Marketing Authorization
Plain-language explanation, inspection context and common violation patterns.
What it says
This guideline describes the nonclinical safety studies and their timing relative to clinical development, so that the nonclinical package supports each phase of human trials and, ultimately, marketing authorization.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- It aligns the nonclinical program with the clinical program, so human exposure is supported by adequate animal data at each stage.
- Nonclinical studies supporting a submission are expected to follow Good Laboratory Practice, linking this guideline to 21 CFR Part 58.
- Quality teams meet it indirectly, since impurity qualification and material used in nonclinical studies relate to what is manufactured later.
What inspectors look for
- Whether nonclinical safety studies were conducted under GLP and the records support the reported results.
- Whether the material used in nonclinical studies was adequately characterized.
- Whether the nonclinical package supports the clinical exposure and the duration of dosing used in trials.
Most common violation
Nonclinical study records that do not adequately support the reported results or lack evidence of GLP compliance.
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