The document compares the clinical trial application (CTA) process in Canada to the investigational new drug (IND) submission process in the United States. It outlines that in Canada, a single CTA is submitted per protocol for protocol-by-protocol approval, while in the US an open IND allows multiple new protocols to be added through amendments. Both use a Common Technical Document format and have a default 30-day review period, though Canada has additional requirements like listing ongoing clinical trials and sites.

1. Comparing the Canadian CTA to the U.S.
IND Submission Process
Canadian CTA U.S. IND
Principle: Principle:
One Clinical Trial Application (CTA) per protocol. One open Investigational New Drug (IND) throughout
Protocol-by-protocol approval. drug development. New protocols submitted as
amendments.
Format: Format:
Common Technical Document (CTD) Common Technical Document (CTD) or
Investigational New Drug (IND) template
Review: Review:
- 30-day default review period except for Phase 1 - 30-day default period
Bioequivalence studies (7 days) - Information request
- Clarification request - Clinical hold
- Not Satisfactory Notice
- Receipt of a No Objection Letter (NOL)
Administrative Requirements: Administrative Requirements:
- Signature from Canadian representative - Signature from U.S. representative
Canadian Specifications: U.S. Specifications:
- List ongoing Clinical Trials in Canada - Introductory statement
- Clinical Trial Site Information Form (Health Canada - General Investigational plan
database of on going studies and sites) - Investigator data (statement, CV)
- Protocol synopsis or rational product summary - 120 days to submit audited reports
- Foreign Regulatory Authorities refusals - Annual report to FDA
- No annual report
CTA Amendments: IND Amendments:
- Protocol amendment (30 day review): - Protocol amendment: similar requirements
• Quality - New investigator: IND amendment
• Clinical - Response to clinical hold (30 day review)
- New Investigator: Clinical Trial Site Information
Form submitted
- Updated protocol with comprehensive amendment
- Notifications to Health Canada for minor protocol
changes: Clinical Trial discontinuation, IRB refusal
& Clinical Trial closure
Additional Information:
- Unlike INDs, there are no additional summaries to
prepare outside the Investigator’s Brochure, i.e. no
non-clinical or clinical reports to be submitted
- Approximate time to prepare a CTA once the
required data has been received: 1-3 weeks
- Can be submitted at the same time, before or
after an IND
- No review cost for CTAs in Canada
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