Description

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

Resources

Name	Format	Description	Link
Safety Pharmacology Studies for Human Pharmaceuticals ICH Topic S7A	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/safety/safety-pharmacology-studies-human-pharmaceuticals.html
Safety Pharmacology Studies for Human Pharmaceuticals ICH Topic S7A	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/innocuite/etudes-pharmacologiques-innocuite-produits-pharmaceutiques-usage-humain.html

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