00000nam 2200000zi 4500 9.898933 CaOODSP 20221107174959 m o d f cr ||||||||||| 210420s2021 quc o f00| 0 eng d 9780660385297 CaOODSP eng rda CaOODSP n-cn--- En84-240/2021E-PDF Supplementary guidance document for the notification and testing of new substances : organisms used in cell and gene therapy under schedule 1 of the New Substances Notification Regulations (organisms). [Gatineau, QC] : Environment and Climate Change Canada : Health Canada, 2021. 1 online resource (62 unnumbered pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Document d’orientation supplémentaire pour la déclaration et les essais de substances nouvelles selon l’annexe 1 du Règlement sur les renseignements concernant les substances nouvelles (organismes) : organismes utilisés en thérapie cellulaire et génique. Issued also in HTML format. "December 2021." "This supplementary guidance document is intended to complement the Guidelines for the Notification and Testing of New Substances: Organisms (the Guidelines) and provides specific guidance to notifiers on addressing information requirements under Schedule 1 (for release anywhere in Canada, which includes clinical trials) of the New Substances Notification Regulations (Organisms) [the Regulations] for substances that are animate products of biotechnology used in cell and gene therapy and administered to human patients"--page [2]. Gene therapy Canada. Stem cells Research Canada. Canada. Environment and Climate Change Canada, issuing body. Canada. Health Canada, issuing body. Document d’orientation supplémentaire pour la déclaration et les essais de substances nouvelles selon l’annexe 1 du Règlement sur les renseignements concernant les substances nouvelles (organismes) : (CaOODSP)9.898937 PDF 988 KB https://publications.gc.ca/collections/collection_2022/eccc/En84-240-2021-eng.pdf HTML N/A https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/biotechnology-living-organisms/cell-gene-therapy-guidance.html