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Posted On: 04/09/2021 6:56:37 AM
Post# of 148899
From elsewhere:
From other group From: Regulatory_Review / Examen_Reglementaire (HC/SC) <hc.regulatory_review-examen_reglementaire.sc@canada.ca>
Date: Thu, Apr 8, 2021 at 11:51 AM
Subject: RE: Health Canada - How long to review an IO Application (21-106447 - 361)
Cc: Regulatory_Review / Examen_Reglementaire (HC/SC) <hc.regulatory_review-examen_reglementaire.sc@canada.ca>
Dear Mr. xxxxxx.
Thank you for your correspondence from April 1, 2021, regarding the approval of the COVID-19 treatment leronlimab in Canada. Before leronlimab can be made available to Canadians, Health Canada must conduct an in-depth review of thesupporting data on safety, efficacy, and quality. The time it takes to authorize a COVID-19 vaccine or treatment varies, depending on many factors, including the need for additional data, discussions with the sponsor, requirements for updates to safety information, etc.
The normal target date for a submission under theFood and Drug Regulations is 300 days from date of submission. However, in this time of crisis, the Minister of Health has enacted the interim order pathway for COVID-19-related drugs and vaccines, which allows Health Canada to expedite more timely approvals of COVID-19 health products via rolling submissions. The nature of rolling submissions means that a firm target date cannot be set, but approval decisions for COVID-19 health products submitted under the interim order have been issued between 34 and 148 days after submission.
The review for leronlimab is ongoing, andHealth Canada will issue a decision once the evidence has been received and reviewed.
For further information on drug and vaccine applications received and authorized for COVID-19, please visitDrug and vaccine authorizations for COVID-19: List of applications received.
We hope this information is helpful to you.
Sincerely, Regulatory Review of Drugs & Devices | Examen réglementaire des médicaments et des instrumentsHealth Products and Food Branch | Direction générale des produits de santé et des alimentsHealth Canada | Santé Canada100 Eglantine DrivewayTunney's Pasture | Pré Tunney, Ottawa K1A 0T6Mail stop | Localisateur: 0602C
From other group From: Regulatory_Review / Examen_Reglementaire (HC/SC) <hc.regulatory_review-examen_reglementaire.sc@canada.ca>
Date: Thu, Apr 8, 2021 at 11:51 AM
Subject: RE: Health Canada - How long to review an IO Application (21-106447 - 361)
Cc: Regulatory_Review / Examen_Reglementaire (HC/SC) <hc.regulatory_review-examen_reglementaire.sc@canada.ca>
Dear Mr. xxxxxx.
Thank you for your correspondence from April 1, 2021, regarding the approval of the COVID-19 treatment leronlimab in Canada. Before leronlimab can be made available to Canadians, Health Canada must conduct an in-depth review of thesupporting data on safety, efficacy, and quality. The time it takes to authorize a COVID-19 vaccine or treatment varies, depending on many factors, including the need for additional data, discussions with the sponsor, requirements for updates to safety information, etc.
The normal target date for a submission under theFood and Drug Regulations is 300 days from date of submission. However, in this time of crisis, the Minister of Health has enacted the interim order pathway for COVID-19-related drugs and vaccines, which allows Health Canada to expedite more timely approvals of COVID-19 health products via rolling submissions. The nature of rolling submissions means that a firm target date cannot be set, but approval decisions for COVID-19 health products submitted under the interim order have been issued between 34 and 148 days after submission.
The review for leronlimab is ongoing, andHealth Canada will issue a decision once the evidence has been received and reviewed.
For further information on drug and vaccine applications received and authorized for COVID-19, please visitDrug and vaccine authorizations for COVID-19: List of applications received.
We hope this information is helpful to you.
Sincerely, Regulatory Review of Drugs & Devices | Examen réglementaire des médicaments et des instrumentsHealth Products and Food Branch | Direction générale des produits de santé et des alimentsHealth Canada | Santé Canada100 Eglantine DrivewayTunney's Pasture | Pré Tunney, Ottawa K1A 0T6Mail stop | Localisateur: 0602C
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