Templates
- Biopharmaceutics Classification System (BCS)-based Biowaiver Evaluation template [2020-08-26]
- A blank Foreign Review Attestation template is available in Microsoft™ Word® upon request. To receive a blank Foreign Review Attestation template, please email policy_bureau_enquiries@hc-sc.gc.ca.
- Notice - Protocol Safety and Efficacy Assessment Template - Clinical Trial Application (PSEAT-CTA) [2008-02-27]
- Protocol Safety and Efficacy Assessment Template - Clinical Trial Application [2008-02-27]
- Appendix C: Request for Human drugs Reconsideration Template (PDF Version - 301 K) [2019-07-26]
- Notice - Draft Comprehensive Summary : Bioequivalence (CS-BE) [2004-05-18]
- Draft Comprehensive Summary - Bioequivalence (CS-BE) [2004-05-18]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase I) (QOS-CE (CTA - Phase I)) [2008-11-12]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase II) (QOS-CE (CTA - Phase II)) [2008-11-12]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase III) (QOS-CE (CTA - Phase III)) [2008-11-12]
- Overall Summary - Chemical Entities (Clinical Trial Applications - Bioavailability Studies) (QOS-CE (CTA - BA)) (PDF fillable/saveable (667 KB)) [2015-12-23]
(DOC Version - 73 K) - Quality Overall Summary - Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions) (QOS-CE (NDS/ANDS)) [2004-04-01]
- Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) (QOS-CE (DINA)) [2004-04-01]