Comparing the Canadian CTA to the U.S. IND submission process.

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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