Revision to an administrative practice regarding the acknowledgement of receipt of Clinical Trial Application Notifications received in the Office of Clinical Trials of the Therapeutic Products Directorate
Date: July 30, 2014
Our file number: 14-109392-501
Health Canada is hereby informing all sponsors [for example (e.g.) industry, academic, contract research organization, etc.] of clinical trials, as well as Research Ethics Boards involved in the approval of clinical trial protocols, of a change in administrative practice pertaining to clinical trials falling under Part C, Division 5 of the Food and Drug Regulations. Specifically, please note that the Office of Clinical Trials will no longer acknowledge receipt of Clinical Trial Application Notifications (CTA-Ns) received in its office, effective as of September 1st, 2014.
Stakeholders are reminded that there is no regulatory requirement for Health Canada to acknowledge receipt of CTA-Ns from sponsors of clinical trials. Please note that a fax receipt or the recipient's signature receipt or any other method to indicate receipt (registered mail, courier) may be considered as the official receipt of a CTA-N being received by the regulator.
The reason for the change is to align our processes internally at Health Canada and to be more efficient. The Office of Clinical Trials currently acknowledges approximately 4,500 CTA-Ns a year, and all parties involved in Clinical Trial Applications would benefit from a reduction in this paper burden.
Questions or comments regarding this should be directed to:
Office of Clinical Trials
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
5th Floor, Address Locator 3105A
Ottawa ON K1A 0K9
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