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Notice - Publication of information about certain Clinical Trial Applications authorized by Health Canada

April 26, 2013

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Notice

Our file Number: 13-107239-925

This Notice serves to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) authorized as of April 1, 2013, for the study of drugs in patients. As you may be aware, Health Canada recently consulted on its intention to launch a publicly available clinical trials database. This initiative will be implemented shortly, in May 2013, and will include trials that were issued a No-Objection-Letter (NOL) as of April 1, 2013.

If a CTA is authorized, and involves a trial in patients (phase I, II, or III), the following information about the clinical trial will be published by Health Canada in its publicly accessible database: protocol number, protocol title, drug name, medical condition, study population, authorization date, sponsor name, Health Canada control number, and the start and end date of the clinical trial, if known. Information about each CTA that is authorized will be published soon after the NOL is issued, and the database will be updated nightly as information becomes available, such as trial commencement or trial completion.

Questions or concerns related to this Notice should be directed to:

Office of Clinical Trials
Therapeutic Products Directorate
Health Canada
Holland Cross, Tower B, 5th Floor
Address Locator 3105A
1600 Scott Street
Ottawa, Ontario
K1A 0K9

E-mail: OCT_BEC_Enquiries@hc-sc.gc.ca