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).: En84-240/2021E-PDF
"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].
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.898933&sl=0
| Department/Agency | Canada. Environment and Climate Change Canada, issuing body. Canada. Health Canada, issuing body. |
|---|---|
| Title | 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). |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | 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." |
| Publishing information | [Gatineau, QC] : Environment and Climate Change Canada : Health Canada, 2021. |
| Description | 1 online resource (62 unnumbered pages) |
| ISBN | 9780660385297 |
| Catalogue number |
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| Subject terms | Gene therapy -- Canada. Stem cells -- Research -- Canada. |
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