00000nam 2200000za 4500 9.833169 CaOODSP 20221107150147 cr ||||||||||| 170426t20172016onc o f000 0 eng d 978-0-660-07793-2 CaOODSP eng n-cn--- H164-205/2017E-PDF Public release of clinical information in drug submissions and medical device applications [electronic resource] / Health Products and Food Branch. Ottawa : Health Canada, 2017, c2016. 8 p. 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." "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. gccst Drugs gccst Medical products gccst Freedom of information gccst Government policy Canada. Health Canada. Canada. Health Products and Food Branch. Diffusion publique de renseignements cliniques dans les présentations de médicaments et les demandes d’homologation d’instruments médicaux (CaOODSP)9.833171 PDF 124 KB https://publications.gc.ca/collections/collection_2017/sc-hc/H164-205-2017-eng.pdf 160346