Safety Pharmacology Studies for Human Pharmaceuticals ICH Topic S7A

Safety Pharmacology Studies for Human Pharmaceuticals ICH Topic S7A 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. 2023-12-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetysafety pharmacology studieshuman pharmaceuticalsICH Topic S7A Safety Pharmacology Studies for Human Pharmaceuticals ICH Topic S7AHTML 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 S7AHTML 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

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.

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