Once I Submit, What Next?
Once submitted, phase II and III CTAs and their amendments are subject to a 30-day default review period from the date of receipt by Health Canada.
Health Canada also targets to review applications to conduct comparative bioavailability trials and phase I trials in healthy adult volunteers within 7 days (except those using somatic cell therapies, xenografts, gene therapies, prophylactic vaccines or reproductive and genetic technologies).
Each submission is issued a control number and you will be requested to refer to this number in all correspondence.
All CTAs and CTA-Amendments will be screened for acceptability, and deficiencies identified at screening will be addressed with sponsor.
Due to tight deadlines with respect to review, requests for clarification issued usually as a fascimile must be answered in writing within 2 calendar days.
After the review period, if the CTA is deemed acceptable, a No Objection Letter (NOL) will be issued within the review period. A Not Satisfactory Notice (NSN) will be issued if significant deficiencies are identified during the review of the CTA or if a timely response to the clarification request issued has not been provided.
Prior to initiating or implementing a change to a clinical trial at a site, the proposed trial protocol and informed consent must be reviewed and approved by a qualified Research Ethics Board (REB).