Templates on applications and submissions for drug products
Some documents are only available by request and are labeled as "available upon request". When you select one of those links, an email message will open with the required information already filled in. Simply 'Send' the message. Alternatively, you can also email the address provided for each document and include the subject line specified in the list below.
- Biopharmaceutics classification system (BCS)-based biowaiver evaluation template (available upon request at no-reply.PDD.Publications.DMP.non-reponse@hc-sc.gc.ca). The email subject line must read “Biopharmaceutics Classification System (BCS)-Based Biowaiver Evaluation Template”. For further information, contact bpsenquiries@hc-sc.gc.ca. [2026-03-05]
- 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]
- Comprehensive summary - bioequivalence (CS-BE) template (available upon request at no-reply.PDD.Publications.DMP.non-reponse@hc-sc.gc.ca). The email subject line must read “Comprehensive Summary - Bioequivalence (CS-BE) Template”. For further information, contact bpsenquiries@hc-sc.gc.ca. [2026-03-05]
- 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 K)) [2015-12-23]
(DOC Version - 73 K) - Notice - Quality Overall Summary - Chemical Entities [2004-04-28]
- 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]