ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
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ICH M3(R2) is an international guideline that harmonizes requirements for nonclinical safety studies needed to support the initiation and progression of human clinical trials and the marketing authorization of pharmaceuticals.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
regulatory guideline ⓘ |
| addresses |
bridging strategies between regions
ⓘ
flexibility based on clinical context and risk ⓘ risk mitigation for human subjects in clinical trials ⓘ |
| aimsTo |
avoid redundant nonclinical testing across regions
ⓘ
ensure adequate safety margins for human exposure ⓘ support ethical use of animals in research ⓘ |
| appliesTo |
biotechnological products
ⓘ
pharmaceuticals for human use ⓘ small-molecule drugs ⓘ |
| covers |
carcinogenicity study considerations
ⓘ
duration of repeated-dose toxicity studies ⓘ genotoxicity testing requirements ⓘ reproductive and developmental toxicity testing strategy ⓘ safety pharmacology requirements ⓘ special toxicity studies when warranted ⓘ timing of nonclinical studies relative to clinical trials ⓘ toxicology study design recommendations ⓘ |
| defines |
nonclinical data needed to support clinical trial progression
ⓘ
nonclinical data needed to support first-in-human clinical trials ⓘ nonclinical data needed to support marketing authorization ⓘ |
| endorsedBy |
European Medicines Agency
NERFINISHED
ⓘ
Pharmaceuticals and Medical Devices Agency Japan NERFINISHED ⓘ U.S. Food and Drug Administration NERFINISHED ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| objective |
facilitate timely conduct of clinical trials
ⓘ
harmonize global requirements for nonclinical safety studies ⓘ reduce unnecessary animal use in drug development ⓘ support global drug development programs ⓘ |
| partOf | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines NERFINISHED ⓘ |
| provides |
decision trees for nonclinical program design
ⓘ
guidance on duration of chronic toxicity studies for marketing applications ⓘ guidance on timing of reproductive toxicity studies ⓘ recommendations for exploratory clinical trials ⓘ |
| region |
European Union
NERFINISHED
ⓘ
Japan NERFINISHED ⓘ United States of America ⓘ
surface form:
United States
|
| relatedTo |
ICH S1 Carcinogenicity Studies Guidelines
NERFINISHED
ⓘ
ICH S5 Reproductive Toxicity Testing Guidelines NERFINISHED ⓘ ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals NERFINISHED ⓘ ICH S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization NERFINISHED ⓘ |
| replaces | ICH M3(R1) NERFINISHED ⓘ |
| scope |
nonclinical safety studies to support all phases of clinical development
ⓘ
nonclinical safety studies to support marketing authorization applications ⓘ |
| shortName | ICH M3(R2) NERFINISHED ⓘ |
| subjectOf | nonclinical safety studies requirements ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
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relatedTo
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ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
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