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ARCHIVED Information and application requirements for drugs authorized under the Interim Order: Guidance document - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 170853
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ARCHIVED Information and application requirements for drugs authorized under the Interim Order: Guidance document - Canada.ca
2 janv. 2026
hc-20260101
ID 429090
updated1 sections changed
1 sections modifiées0 ajoutées0 retirées+2 / -7 lignesVariation: 1%
--- +++ @@ -249,9 +249,7 @@ Application information and requirements for veterinary drugs An application for authorization of a COVID-19 drug should contain all available information to inform an assessment of the drug including evidence of its efficacy in the target species, animal safety, human safety, and quality. If the drug is to be used in a food-producing animal, information should be provided regarding the safety of drug residues in meat and other food products from the treated animal intended for human consumption. Risk Management Plan-A Risk Management Plan (RMP) should be submitted that focuses on the safety risks for the product in the context of COVID-19 use. An RMP is a document that outlines pharmacovigilance activities and interventions to identify, characterize, prevent or minimize risks related to drug products. The RMP also contains an evaluation of the effectiveness of such risk minimization measures. Applicants should refer to-Guidance Document Submission of Risk Management Plans and Follow-Up Commitments-for additional information on the scope of RMPs.+A Risk Management Plan (RMP) should be submitted that focuses on the safety risks for the product in the context of COVID-19 use. An RMP is a document that outlines pharmacovigilance activities and interventions to identify, characterize, prevent or minimize risks related to drug products. The RMP also contains an evaluation of the effectiveness of such risk minimization measures. Applicants should refer to Guidance Document Submission of Risk Management Plans and Follow-Up Commitments for additional information on the scope of RMPs. The RMP in the context of the COVID-19 drugs submitted for authorization under the Interim Order can be abbreviated but should include the following: a safety specification that details the identified risks, potential risks, and missing information (for example, special populations with limited information from (or were excluded from) clinical trials) for the product, with a focus on risks in COVID-19 patients a pharmacovigilance plan that details specific measures to be taken to identify and report safety issues in COVID-19 patients, including expedited adverse reaction reporting, periodic reporting (for example, a monthly Periodic Benefit Risk Evaluation Report), and ongoing/planned studies (for example, registries, questionnaires)@@ -294,9 +292,7 @@ Paragraph 4(2)(c) of the Interim Order requires the applicant to provide information that demonstrates that the drug is identical to, and is manufactured, prepared and packaged in the same manner as, the foreign drug. Foreign regulatory authorization Paragraph 4(2)(d) of the Interim Order requires the applicant to provide information that demonstrates that the sale of the foreign drug is authorized by that foreign regulatory authority. This evidence should include a copy of the formal authorization letter, including any conditions imposed, issued by the authority, as well as any review summaries authored by the authority, including details of additional measures to support pharmacovigilance or risk mitigation. If the Minister deems that the evidence of authorization by a foreign authority is insufficient to ensure that section 5 of the Interim Order is met, the Minister may request additional information under section 13 of the Interim Order, and may also decide to issue an authorization with terms and conditions under section 10.-As per submission requirements for a COVID-19 drug, a RMP should be submitted that includes a safety specification, pharmacovigilance plan, and risk minimization plan, if applicable. See the-Guidance Document - Submission of Risk Management Plans and Follow-Up Commitments-for additional information on the scope of RMPs. The RMP can be from a foreign source but should address all safety concerns and contains information on use in COVID-19 in the Canadian context.+As per submission requirements for a COVID-19 drug, a RMP should be submitted that includes a safety specification, pharmacovigilance plan, and risk minimization plan, if applicable. See the Guidance Document - Submission of Risk Management Plans and Follow-Up Commitments for additional information on the scope of RMPs. The RMP can be from a foreign source but should address all safety concerns and contains information on use in COVID-19 in the Canadian context. If a foreign jurisdiction waives pre-market submission and evaluation requirements, this would not be considered a foreign regulatory authorization for the purposes of the Interim Order. Note that pathways that involve reduced filing requirements may not be acceptable under this provision. Labels approved by foreign regulatory authority Paragraph 4(2)(e) of the Interim Order requires that the applicant provides a copy of the label of the COVID-19 drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, that are approved by that foreign regulatory authority for use in connection with the foreign drug.@@ -837,5 +833,4 @@ Signature: Date: Page details-Date modified: 2022-03-09