Canada’s regulatory approach to drugs for rare diseases: apply and register for clinical trials

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Health Canada’s Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) are responsible for reviewing the applications for authorization to sell or import drugs for the purposes of conducting clinical trials in Canada.

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Canada’s regulatory approach to drugs for rare diseases: apply and register for clinical trials HTML https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/regulatory-approach-drugs-rare-diseases/clinical-trials-apply.html
Canada’s regulatory approach to drugs for rare diseases: apply and register for clinical trials HTML https://www.canada.ca/fr/sante-canada/services/licences-autorisation-et-enregistrement-medicaments-et-produits-sante/approche-canada-reglementation-medicaments-maladies-rares/essais-cliniques-demande.html

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