Health Canada announces the release of the final guidance document A Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies.
The purpose of this document is to provide guidance to sponsors seeking authorization to sell or import a positron-emitting radiopharmaceutical (PER) for the purpose of a basic clinical research study in Canada.
Questions related to this guidance document may be directed to:
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Address Locator: 0601B
100 Eglantine Driveway, Tunney’s Pasture
Ottawa, Ontario K1A 0K9