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COVID-19 clinical trials IO and clinical trials records retention: Consultation report Learn about the outcomes of the public consultations on the COVID-19 clinical trials Interim Order and clinical trials records retention. On this page COVID-19 clinical trials interim order and…
ARCHIVED Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents Notice to Reader: We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See…
Notice: Prescription Drug List (PDL): Casirivimab and Imdevimab (COVID-19) Date: June 17, 2021 Our file number: 21-111549-461 The purpose of this Notice of Amendment is to notify about the addition of casirivimab and imdevimab to the Prescription Drug List (PDL) for human and…
Notice: Prescription Drug List (PDL): Sotrovimab (COVID-19) Date: August 5, 2021 Our file number: 21-114312-127 The purpose of this Notice of Amendment is to notify about the addition of sotrovimab to the Prescription Drug List (PDL) for human and veterinary use. The new…
Access Consortium: Alignment with ICMRA consensus on immunobridging for authorizing new COVID-19 vaccines Placebo-controlled disease endpoint trial data are the gold standard for authorizing vaccines. However, for COVID-19 vaccines, it is difficult to conduct efficacy trials in…
AstraZeneca Vaxzevria COVID-19 vaccine All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality. Name: AstraZeneca Vaxzevria® COVID-19 vaccine Manufacturer: AstraZeneca Canada Inc and Verity/SII (COVISHIELD) Type: Viral vector-based Status:…
Guidance for market authorization requirements for COVID-19 drugs: Overview Overview Rolling submissions and reviews Non-clinical and clinical requirements Quality and manufacturing requirements Labelling and post-market requirements Communications and transparency Download the…
What we heard report: Records retention consultations related to the clinical trials interim order transition regulations On this page About the clinical trials interim order About the transition approach About the consultations What stakeholders said Next steps About the…
Access Consortium statement on COVID-19 medicines December 14, 2021 On this page Our commitment Monitoring safety and effectiveness (pharmacovigilance) Impact of initial approvals Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still…
Notice: Nirmatrelvir (COVID-19) added to Prescription Drug List (PDL) January 17, 2022 Our file number: 22-100536-553 The purpose of this Notice of Amendment is to notify about the addition of nirmatrelvir to the Prescription Drug List (PDL) for human and veterinary use. The new…
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