Description

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals.

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Name	Format	Description	Link
M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/multidisciplinary/guidance-nonclinical-safety-studies-conduct-human-clinical-trials-marketing-authorization-pharmaceuticals.html
M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/multidisciplinaire/directive-etudes-innocuite-non-cliniques-requises-etudes-cliniques-chez-humain-autorisations-mise-marche-produits-pharmaceutiques.html

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