Notice - Revision to an administrative practice regarding the receipt of Clinical Trial Applications by the Biologics and Genetic Therapies Directorate

Health Canada is hereby informing all sponsors (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 Regulatory Affairs in the Biologics and Genetic Therapies Directorate (BGTD) request that clinical trial applications and amendments not be filed from December 15 to January 2. We respectfully request your cooperation effective December 15, 2014.

The rationale for this change is that a large number of clinical trial applications are filed in late December placing strain on limited resources available during the holiday period to meet the default performance targets for screening and review. A controlled intake of clinical trial applications/amendments would allow the screening and reviews to be completed during a time when a full roster of staff is present.  This proposal is in line with an ongoing assessment, within the Branch, to seek efficiencies in the submission review process.

Health Canada would also ask that sponsors always provide a contact name who can address any questions relating to the review of the clinical trial or amendment filed in the first two weeks of December given that the 30 day default will fall towards the end of December. Having a contact person available during the December period will prevent delays in the approval of your application.

Health Canada receives approximately 1500 clinical trial applications each year and a similar number of clinical trial amendments.

Questions or comments regarding this proposal should be directed to:

Office of Regulatory Affairs
Biologics and Genetic Therapies Directorate
Health Canada
200 Tunney's Pasture  
Address Locator 0700A
Ottawa ON K1A 0K9

Facsimile: 613-946-9520
E-mail: bgtd_ora@hc-sc.gc.ca