Canadian CTA vs. U.S. IND

Comparing the Canadian CTA to the U.S. IND Submission Process Canadian CTA U.S. INDPrinciple: Principle:One Clinical Trial Application (CTA) per protocol. One open Investigational New Drug (IND) throughoutProtocol-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) templateReview: 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. representativeCanadian 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 reportCTA 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 closureAdditional 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 www.scimega.com

Canadian CTA vs. U.S. IND

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Canadian CTA vs. U.S. IND Document Transcript