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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 Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

Resources

Name	Format	Description	Link
ICH E8(R1): General Considerations for Clinical Studies	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/general-considerations-clinical-trials-topic.html
ICH E8(R1): General Considerations for Clinical Studies	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/efficacite/intention-industrie-considerations-generales-relatives-etudes-cliniques-theme.html

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