Notice - Revisions to the Clinical Trial Application Guidance Documents for Clinical Trial Sponsors

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Contact: Office of Clinical Trials

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June 28, 2010

Notice

Our file number: 10-113885-967

To Stakeholders: Revisions to the Clinical Trial Application Guidance Documents for Clinical Trial Sponsors

Health Canada has commenced a process to update and finalize guidances that assist sponsors in seeking authorization to conduct a clinical trial:

• Online Clinical Trials Manual;
• Guidance for Clinical Trial Sponsors: Clinical Trial Applications (2003); and
• Draft Guidance for Industry: Clinical Trial Applications for Comparative Bioavailability Studies for Pharmaceuticals (2001).

In 2006, Health Canada initiated the statutory review of Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects). As part of the review, stakeholder consultations were undertaken to seek advice on improving the clinical trials regulatory framework. The Clinical Trials Regulatory Review: Targeted Measures for a Strengthened Framework, published in March 2008, outlines a series of initiatives that will further support Health Canada's objectives of strengthening the protection of clinical trial subjects, while attracting and sustaining investments in research and development in Canada. One of these initiatives is to provide enhanced guidance to sponsors in meeting regulatory obligations pursuant to the Food and Drug Regulations.

During consultations, stakeholders noted the need for additional guidance specifically related to the clinical trial application process, the submission requirements of clinical trials in Phases I through Phase III and comparative bioavailability trials. They also sought clear and consistent definitions, and clarity on the roles and responsibilities for terms of clinical trial activities.

Since the posting of the Clinical Trials Regulatory Review: Targeted Measures for a Strengthened Framework, Health Canada has published revisions to the guidance document on quality requirements for clinical trial applications and the clinical trial site information form.

Health Canada has established an internal multi-Directorate working group to develop proposed revisions to the current guidance documents. Detailed stakeholder input will be sought on the draft documents.

Questions or comments regarding this initiative should be directed to:

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

Facsimile: (613) 954-4474
E-mail: CTA_Guidance_Revision@hc-sc.gc.ca