M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 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. 2023-12-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyM3(R2)Questions-and-Answers (R2)guidancenonclinical safety studieshuman clinical trialsmarketing authorizationpharmaceuticalsICH Expert Working-Groupregulatory parties M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsHTML 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 PharmaceuticalsHTML 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

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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