Guidance for industry : priority review of drug submissions / Health Products and Food Branch. : H169-4/2009E-PDF
"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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.907191&sl=1
| Ministère/Organisme | Canada. Health Products and Food Branch, issuing body. |
|---|---|
| Titre | Guidance for industry : priority review of drug submissions / Health Products and Food Branch. |
| Variante du titre | Priority review of drug submissions |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Édition précédente | Guidance for industry - priority review of drug submissions 2007 |
| Format | Électronique |
| Document électronique | |
| Note(s) | "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. |
| Information sur la publication | Ottawa, Ontario : Health Canada = Santé Canada, 2009. ©2009 |
| Description | 1 online resource (iii, 19 pages) |
| Numéro de catalogue |
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| Descripteurs | Drug approval -- Canada. |