Submissions Containing Clinical Data from Studies Conducted outside of Canada

June 5, 2009


Our file number: 09-114651-928

Submissions Containing Clinical Data from Studies Conducted outside of Canada

Drug development is becoming increasingly global and Health Canada is receiving clinical studies submitted in support of a Canadian market authorization that are conducted outside of Canada. There have been instances where, during the course of a submission / application review, the integrity of the clinical data has been questioned. Health Canada has begun an examination of issues pertaining to data from foreign clinical studies to determine if further guidance in this regard is needed and if so, the nature of that guidance.

In the interim, Health Canada is reminding sponsors of its expectation that the clinical studies submitted in support of a Canadian market authorization were conducted in accordance with internationally recognized Good Clinical Practice standards that guide the ethical and scientific conduct of clinical research.

This Notice applies to submissions for all product lines, specifically:

  1. medical device licence applications subject to the Medical Devices Regulations;
  2. product submissions pursuant to the Food and Drug Regulations (including pharmaceuticals, biologics, radiopharmaceuticals and veterinary products); and
  3. applications for a natural health product licence pursuant to the Natural Health Products Regulations.

The above-noted regulations and supporting guidances set out submission requirements for safety, quality and effectiveness data which form the basis of Health Canada's review. In addition, Health Canada has adopted the vast majority of the International Conference on Harmonisation guidelines through policy and regulatory change. For the ethical and scientific conduct of clinical research involving humans and animals, Health Canada generally recognizes the following international standards:

  • Global Harmonization Task Force (GHTF) ISO TC 194 is the recognized standard for the conduct and performance of clinical investigations of in vivo medical devices. The document consists of two parts:
    • ISO 14155-1 (Clinical investigation of medical devices for human subjects - Part 1: General requirements); and
    • ISO 14155-2 (Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans);
    Note: The standard has been revised and is expected to be superseded by a new version which will also be acceptable to Health Canada.
  • International Conference on Harmonisation (ICH) Guideline for Good Clinical Practices E6(R1) (May 1996) is the accepted standard for the design, conduct, recording and reporting of drug clinical trials that involve the participation of human subjects, and;
  • Veterinary International Conference on Harmonisation (VICH) Topic GL9 (Good Clinical Practice) (July 2001) is the consensus guideline for veterinary drug products.

When clinical data from studies conducted outside of Canada are included in a submission/application to meet Canadian criteria for market authorization, Health Canada will examine the foreign clinical trial data in accordance with the provisions of the relevant regulations and supporting guidances in order to determine whether the results are considered to be accurate and reliable. Studies conducted in accordance with, among others, the standards ISO 14155, ICH E6 GCP or VICH Topic GL9, as applicable, would assist a sponsor in meeting Health Canada requirements.

If Health Canada has concerns regarding adherence with the recognized standards set out above, the sponsor will be asked to provide satisfactory evidence to establish that the data from the foreign trial were obtained while meeting the above recognized standards or their equivalents. The evidence will be considered on a case by case basis. If the evidence is not considered to be satisfactory, a Health Canada authorization may not be issued.

More information on this initiative, including next steps, will be made available on the Health Canada Web site as our work progresses. Stakeholders will be consulted as the initiative moves forward.

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

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Holland Cross, Tower B, Address Locator 3102C3
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Facsimile: 613-941-1812

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