Public release of clinical information in drug submissions and medical device applications / Health Products and Food Branch. : H164-205/2017E-PDF
"This document introduces Health Canada’s initiative to publicly release clinical information concerning the safety and efficacy of drugs and safety and effectiveness of medical devices. It sets out the policy objectives, rationale and considerations for future regulations that would specify that certain clinical information contained in drug submissions or medical device applications would not be treated or cease to be confidential business information following a final regulatory decision and that would authorize the public release of that information"--Preface, p. 1.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.833169&sl=1
| Ministère/Organisme | Canada. Health Canada. Canada. Health Products and Food Branch. |
|---|---|
| Titre | Public release of clinical information in drug submissions and medical device applications / Health Products and Food Branch. |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Issued also in French under title: Diffusion publique de renseignements cliniques dans les présentations de médicaments et les demandes d’homologation d’instruments médicaux. Cover title. "March 10, 2017." |
| Information sur la publication | Ottawa : Health Canada, 2017, c2016. |
| Description | 8 p. |
| ISBN | 978-0-660-07793-2 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 160346 |
| Descripteurs | Drugs Medical products Freedom of information Government policy |
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