Public release of clinical information in drug submissions and medical device applications: 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.

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Department/Agency Health Canada. Health Products and Food Branch.
Title Public release of clinical information in drug submissions and medical device applications
Publication Type Monograph
Language [English]
Other Language Editions [French]
Format Electronic
Electronic Document

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Note 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."
Date 2017, c2016.
Number of Pages 8 p.
ISBN 978-0-660-07793-2
Catalogue Number
  • H164-205/2017E-PDF
Departmental Catalogue Number 160346
Subject Terms Drugs, Medical products, Freedom of information, Government policy