Module 5 Presentations

18/07/2024

Health Canada - CTA Process

Initial screening (validation) phase ● Response time to queries is usually 2 calendar days. Application is processed for review and an acknowledgement letter is sent to the applicant containing: date of review start, file #, control # (per protocol). ● 30-day review period* by Health Canada * Phase 1 & healthy volunteer trials: Administrative target review period is 7 days, except for ATMPs. ● Health Canada reviewer will email a Request for Clarification (“Clarifax” ), listing all questions or comments; response time is typically 2 calendar days. Once review is completed, the CTA is either: ● AUTHORIZED – No Objection Letter (NOL) is issued OR REJECTED – Not Satisfactory Notice (NSN) is issued. ● Notices are issued by email.

The Organisation for Professionals in Regulatory Affairs

37

Hea lth Canada CTA Amendments & Notifications

CTA Amendment (CTA-A) must be filed:

• To an original CTA (protocol or quality changes) which were previously approved and that impact the safety of the subjects or affect the analysis/interpretation of the safety and efficacy of the IMP.

• 30-day review period by Health Canada, with the issuance of a new NOL.

CTA-As must be authorized prior to implementation of the change(s).

Notifications may be implemented immediately, but Health Canada must be informed, within 15 calendar days of the change: • Administrative changes: site closures, completions of a trial, discontinuations, screening period increases, changes to contact names in the protocol involved in the conduct of the trial, annual IB updates, REB or MoH refusals globally. • Quality changes (that do not affect the quality or safety of the IMP): all shelf life extensions for Pharmaceuticals (for Biologics, if approved shelf life is > 18 months), tightening of acceptance criteria/specifications, changes in contract testing laboratories (release and stability).

A new authorization is not received from Health Canada; an acknowledgement of receipt is received by email.

The Organisation for Professionals in Regulatory Affairs

38

19