Certain clinical trials involving drugs, medical devices or natural health products may require an application for regulatory approval be filed with Health Canada prior to the recruitment of the first study subject.
Clinical researchers must be familiar with the details of the "Regulations amending the food and drug regulations (1024 - clinical trials)" which were amended to require sponsor submission of a clinical trial application (CTA) for drug trials, a reduced default time for Health Canada review of applications, sponsor compliance with Good Clinical Practices (GCP), and Health Canada inspections/compliance verifications. These regulations apply to clinical trials (Phase I – Phase III) for both new investigational drugs and some marketed drugs.
It is important to note, that the use of marketed drugs outside of the approved indication (i.e. new age group, new disease entity or new dose range) now require Health Canada approval for use in a clinical trial, whether investigator or industry initiated.
Following receipt of a CTA by a study sponsor and Health Canada's internal review, either a 'No objection letter' (NOL) or 'Not satisfactory notice' is issued by Health Canada. Any protocol amendments following the initial approval of the trial must also be submitted to Health Canada for approval. The Biomedical Research Ethics Board (BREB) withholds the certificate of final ethical approval pending receipt of a copy of the study's 'No objection letter' for new study submissions and subsequent applicable protocol amendments.
Clinical trials involving medical devices require a similar but separate process under the Medical Device Regulations; however REB approval is required by Health Canada prior to the Bureau releasing the Investigational Testing Authorization (ITA) letter. Following receipt of the ITA by the sponsor/Investigator, the BREB requests that the site forward a copy of this letter to the office.
A similar Health Canada review and approval process exists for clinical trials involving natural health products. Under the Natural Health Product Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:
Vitamins and minerals
Traditional medicines such as traditional Chinese medicines
Other products like amino acids and essential fatty acids.
Submissions satisfying the NHP Directorate's requirements will be issued a "Notice of Authorization" to commence the trial. The Biomedical Research Ethics Board (BREB) withholds the certificate of final ethical approval pending receipt of a copy of the study's Notice of Authorization for new study submissions and subsequent applicable protocol amendments.
For further information, please refer to their Web site at http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/index_e.html
If there is any uncertainty as to whether a trial involving drugs, food, medical devices and/or natural health products requires Health Canada approval the researcher is encouraged to contact Health Canada.
The University of Manitoba Health Research Ethics Board (HREB) and Biomedical Research Ethics Board (BREB) will not sign the Health Canada REB Attestation Form. The University of Manitoba HREB/BREB currently uses an Ethics Approval certificate that contains the required attestation as per Health Canada regulations and this should be used by the sponsor in lieu of the Health Canada REB Attestation Form. We refer you to Section 14(b) of the Guidance for Clinical Trial Sponsors: Clinical Trial Application dated 2003/06/25 which states, "Research Ethics Board(s) may wish to use the Research Ethics Board Attestation(s) or develop similar documentation that meets the requirement of Part C, Division 5 of the Food and Drug Regulations".
Some clinical trial records must be retained for a period of 25 years post study closure.
Updated guidance effective June 15, 2006 regarding the retention of records and the conditions under which they are to be made available for monitoring, auditing and inspection related to clinical trials can be found at the following Health Canada website: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/gui_68_tc-tm_e.html
Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Patients can access the database to determine if a clinical trial has met the regulatory requirements. The database may also assist Canadians in finding clinical trials that might be relevant to their medical condition. The Clinical Trials Database is not a registry, and therefore, it does not contain comprehensive information about each clinical trial. To maximize use of the database and available information, users are advised to link to external resources, including publicly available registries, to obtain further information such as trial objectives and patient eligibility.
Institution/Investigator Initiated Clinical Trials - Health Canada submission requirements
HEALTH CANADA GUIDANCE DOCUMENTS
Drug Product Database
The DPD contains product specific information on drugs approved for use in Canada.