Description

The objective of this Ministerial Order is to ensure that Health Canada is able to review all applications for new clinical trials or amendments to ongoing trials within the default period, by extending the default review period for clinical trial submissions and amendments to 45 days, from 30 days.

Resources

Name	Format	Description	Link
Explanatory note: Order Respecting Certain Time Limits under the Food and Drug Regulations (COVID-19)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/covid-19-order-extension/explanatory-note.html
Explanatory note: Order Respecting Certain Time Limits under the Food and Drug Regulations (COVID-19)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/note-explicative.html

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