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Notice Prescription Drug List (PDL): Bamlanivimab (COVID-19) Date: November 20, 2020 Our file number: 20-116517-414 The purpose of this Notice of Amendment is to notify about the addition of bamlanivimab to the Prescription Drug List (PDL) for human and veterinary use. The new…

Guidance for market authorization requirements for COVID-19 vaccines: Overview Overview Rolling submissions, non-clinical and clinical requirements Quality, manufacturing and lot release requirements Labelling and post-market requirements Requirements for vaccines to address…

Update on remdesivir: continued monitoring Date published: November 26, 2020 The World Health Organization (WHO) is conditionally recommending that remdesivir not be used in patients with COVID-19, regardless of how severe the disease is. The WHO released its recommendation and…

Amending the Food and Drug Regulations to provide expedited access to COVID-19 drugs: Closed consultation From: Health Canada Current status: Closed This consultation ran from November 30 th , 2020 to December 21 st , 2020. See the What was heard: Consultation on interim order…

ARCHIVED Consultation on amending the Food and Drug Regulations to expedite access to COVID-19 drugs: Notice to stakeholders Notice to reader: This consultation is now complete. For a summary of the input received, please see the What was heard: Consultation on interim order…

Access Consortium statement on COVID-19 vaccines evidence The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for…

Vaccine development and approval in Canada - Canada.ca

Health CanadaCaptures 13Latest capture Apr 11, 2026en

Vaccine development and approval in Canada Download the alternative format (PDF format, 396 KB, 1 page) Please select a language: العربية (Arabic) 中文 (简体) (Simplified Chinese) 中文 (繁體) (Traditional Chinese) Paskwāwinīmowin (Cree) فارسی (Farsi) हिंदी (Hindi) ᐃᓄᒃᑎᑐᑦ (ᖁᑎᒃᑐᖅ)…

Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory oversight provided by…

ACCESS Consortium: Points to consider for strain changes in authorised COVID-19 vaccines in an ongoing SARS-CoV2 pandemic On this page Executive summary Background Regulatory concepts for influenza virus vaccines Guidance for adapting authorised COVID-19 vaccines for SARS-CoV2…

What was heard: Consultation on interim order transition for tools to address drug and medical device shortages Health Canada consulted with stakeholders about our transition approach to normalize shortage authorities and flexibilities related to shortages . The consultation has…

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