Guidance on applications for drug clinical trials under the interim order: Overview

Guidance on applications for drug clinical trials under the interim order: Overview Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process. 2021-05-28 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyguidancedocumentInterim OrdercoronavirusCOVID-19clinical trialdrugregulationsclinical trial phasesdrug authorizationdrug approval Guidance on applications for drug clinical trials under the interim order: OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/clinical-trials-interim-order-2-drug-guidance.html Guidance on applications for drug clinical trials under the interim order: OverviewHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/essais-cliniques-arrete-urgence-2-medicaments-directrices.html Guidance on applications for drug clinical trials under the interim order: Application guidelines and processHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/clinical-trials-interim-order-2-drug-guidance/applications.html Guidance on applications for drug clinical trials under the interim order: General requirementsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/clinical-trials-interim-order-2-drug-guidance/requirements.html Guidance on applications for drug clinical trials under the interim order: General requirementsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/essais-cliniques-arrete-urgence-2-medicaments-directrices/exigences.html Guidance on applications for drug clinical trials under the interim order: Additional requirementsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/clinical-trials-interim-order-2-drug-guidance/additional-requirements.html Guidance on applications for drug clinical trials under the interim order: Additional requirementsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/essais-cliniques-arrete-urgence-2-medicaments-directrices/exigences-supplementaires.htm Guidance on applications for drug clinical trials under the interim order: Post-authorization requirementsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/clinical-trials-interim-order-2-drug-guidance/post-authorization.html Guidance on applications for drug clinical trials under the interim order: Post-authorization requirementsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/essais-cliniques-arrete-urgence-2-medicaments-directrices/suite-autorisation.html Guidance on applications for drug clinical trials under the interim order: Who to contactHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/clinical-trials-interim-order-2-drug-guidance/contact.html Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documentsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/essais-cliniques-arrete-urgence-2-medicaments-directrices/communiquer.html

Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.

Data and Resources

Similar records