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Health Products and Food Branch
Holland Cross, Tower "A"
2nd Floor, 11 Holland Avenue
Address Locator # 3002C
January 15, 2002
Subject: Inspection Strategy for Clinical Trials
I am pleased to inform you that the approved version of the "Inspection Strategy for Clinical Trials" is now available on the Inspectorate Website at:
This strategy was developed by the Health Products and Food Branch Inspectorate (HPFBI), in consultation with the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB). Comments received from our stakeholders on the draft version published on August 31, 2001 were considered.
The implementation of the inspection component of this inspection strategy starts in January 2002. Activities related to investigations will be performed as needed.
Further communications with representatives of stakeholders will take place in the Fall 2002 to obtain further feedback and communicate expectations of this new inspection function.
Inquiries about this document can be addressed to Jean Saint-Pierre, Coordinator, Good Clinical Practices, National Coordination Centre, Health Products and Food Branch Inspectorate by telephone at (613) 952-8173, by fax at (613) 952-9805 or by e-mail at email@example.com.
Original signed by
Daniele Dionne (for)
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.
Draft issued August 31, 2001
January 15, 2002
Date of implementation
January 15, 2002
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The purpose of this document is to inform all stakeholders involved in clinical trials including sponsors, the research community, patient groups, associations and others about the strategy Health Canada intends to adopt for the effective and uniform implementation of the new Regulations on Clinical Trials as detailed in Division 5 of the Regulations to the Food and Drugs Act.
As part of the regulatory amendments to the Food and Drug Regulations on clinical trials, an inspection function for clinical trials was announced on January 21, 2000 by the Minister of Health. These new regulations, Drugs for Clinical Trials Involving Human Subjects, came into force on September 1, 2001. Regulatory activities to be conducted will include inspections and investigations to assess compliance with these Regulations.
Inspections and investigations will be conducted by Health Canada under the authority of section 23 of the Food and Drugs Act. These activities will be conducted by the Health Products and Food Branch Inspectorate (HPFBI). Collaboration with all stakeholders involved in clinical trials will be essential to ensure compliance with the new Regulations.
Investigations of clinical trials involving any stakeholders may be initiated. As of September 1, 2001, all clinical trials are subject to Division 5; investigations will be carried out in accordance with the new Division. However, in the case of clinical trials authorized prior to September 2001, the applicable Regulations, including Division 8, will be used.
This inspection strategy applies to all clinical trials as defined in Division 5 of the Food and Drug Regulations. Inspections will be performed according to these Regulations, which integrate the rules of conduct of Good Clinical Practices (GCP) as described in the International Conference on Harmonization Guidance document E6 and adopted by the Health Products and Food Branch. Inspections and investigations will be in accordance with Division 5 and will be conducted mainly at Qualified Investigator sites, Sponsors and Contract Research Organizations.
Inspections at Qualified Investigator sites, also referred to as clinical trial sites, will be performed to assess compliance with the Regulations and GCP, as adopted by Health Canada in 1997. These inspections will allow verification of source documents, including medical records, drug accountability and storage conditions. Direct and on-site access to those records should provide increased assurance that the confidentiality of the records will be maintained.
The main objectives for the inspection of clinical trials is to ensure that the generally accepted principles of good clinical practices are met, validate the quality of the data generated, and verify compliance to Division 5 of the Regulations.
For additional definitions, please consult the Food and Drug Regulations, Division 5.
The Health Products and Food Branch (HPFB) will provide information and encourage voluntary compliance to Canadian Regulations and standards. Compliance will be assessed through inspection and investigation.
5.1.1 Two phases are planned for the implementation of inspections. First, there will be a one (1) year confidence building and voluntary phase starting January 1, 2002. During this period, inspections will be performed at the request of the Sponsor. These inspections will be limited in number.
Second, the final implementation phase will commence on January 1, 2003. From that date, the Inspectorate will become responsible for site selection. The selection will be made according to the following criteria:
5.1.2 Inspection activity:
5.1.3 Good Manufacturing Practices (GMP) Inspections of drugs used in clinical trials: GMP inspections will be conducted separately from the GCP inspections and will be in accordance with the regulations and policies pertaining to the manufacture and sale of drug products in Canada.
5.1.4 Rating and reporting:
When a potential noncompliance or risk has been identified by Health Canada, an investigation will be conducted if deemed necessary. Problems or concerns related to the performance of clinical trials may originate from:
Where non-conformity to Regulations is identified, the Sponsor will have the opportunity to correct identified deficiencies. The Inspectorate will consider actions where necessary in accordance with its Compliance and Enforcement Policy. In all cases, the results will be communicated to TPD or BGTD with the information required to make appropriate recommendations regarding:
It is the responsibility of the Inspectorate and all stakeholders to collaborate and act in partnership in the application of this Inspection Strategy.
Specific investigations and inspections activities will be documented and supported by detailed standard operating procedures.
The implementation date of investigation activities under the new Regulation is September 1, 2001. The confidence building and voluntary inspection phase will be initiated on January 1, 2002. It is expected that the second and final phase will start on January 1, 2003.
Communications with representatives of all stakeholders is scheduled to take place in the Fall 2002, once sufficient data has been collected for reporting on the outcome of the first phase of the confidence building and voluntary phase. The objective will be to share further the expectations from the inspection strategy, along with concerns, if any, from this new Regulatory initiative.
1 Food and Drugs Act and Regulations.
2 Compliance and Enforcement Policy. No. POL-0001, Health Products and Food Branch Inspectorate
3 Good Clinical Practice: Consolidated Guideline, International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use - Topic E6.
ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline