00000nam 2200000zi 4500 9.907191 CaOODSP 20221107181325 m o d f cr mn||||||||| 220121t20092009onc o f000 0 eng d CaOODSP eng rda CaOODSP n-cn--- H169-4/2009E-PDF Guidance for industry : priority review of drug submissions / Health Products and Food Branch. Priority review of drug submissions Ottawa, Ontario : Health Canada = Santé Canada, 2009. ©2009 1 online resource (iii, 19 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier "Date Adopted: 2002/09/16." "Revised Date: 2005/11/30." "Effective Date: 2006/03/01." "Administrative Changes Date: 2008/12/18." "Notice: February 6, 2009." "File number: 09-101263-867." Issued also in HTML format. Issued also in French under title: Ligne directrice à l'intention de l'industrie : évaluation prioritaire des présentations de drogues. "This guidance is intended to provide assistance to sponsors in the interpretation of the Priority Review policy and in preparing and submitting a request for Priority Review status. It should be read in conjunction with the Priority Review of Drug Submissions Policy. All therapeutic products sold in Canada must meet safety and effectiveness requirements outlined in Part C of the Food and Drug Regulations. Special consideration relating to drug submissions qualifying under the Notice of Compliance with Conditions (NOC/c) policy, or those sold under C.08.010 and C.08.011 of the Food and Drug Regulations for Special Access purposes, may be warranted. For additional information on the NOC/c policy, refer to “Guidance for Industry; Notice of Compliance with Conditions (NOC/c)”. Information on Health Canada’s Special Access Program is available on the Health Canada Web site. This guidance aims to articulate Health Canada’s expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review request is assessed is provided"--Purpose, page 1. Drug approval Canada. Canada. Health Products and Food Branch, issuing body. Ligne directrice à l'intention de l'industrie : (CaOODSP)9.907195 Guidance for industry - priority review of drug submissions 2007 (CaOODSP)9.688058 PDF 345 KB https://publications.gc.ca/collections/collection_2022/sc-hc/H169-4-2009-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/priority-review/drug-submissions.html