Quality Assurance

Pharmaceutical Drugs / Biological Drugs / Radiopharmaceutical Drugs

A Clinical Trial Applications (CTAs) must be filed with Health Canada in order to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials.

This includes trials involving marketed drugs, where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) or Drug Identification Number (DIN) application.

For example, one or more of the following is different:

• indication(s) and clinical use;
• target patient populations(s);
• route(s) of administration; or
• dosage regimen(s).

It is not required to file a CTA for a clinical trial involving a marketed drug where the investigation is to be conducted within the parameters of the approved NOC or DIN application. This type of trial is referred to as a Phase IV clinical trial.

Natural Health Products (NHPs)

A CTA must be filed with Health Canada in order to conduct a Phase I, II, or III clinical trial for an NHP or a comparative bioavailability study to evaluate the pharmacokinetics of two NHP formulations in healthy volunteers.

This includes trials involving NHPs approved by Health Canada but used outside the parameters of their approved conditions of use.

• “Within approved conditions of use” means that the product is being used as per the product label approved by Health Canada. The product is considered approved by Health Canada if has a Natural Product Number (NPN), Drug Identification Number (DIN), or Drug Identification Number for Homeopathic Medicine (DIN-HM)

Medical Devices

An Investigational Testing Authorization (ITA) application is required for all unlicensed class II, III, and IV medical devices that will be imported and/or sold in Canada for the purpose of investigational testing involving humans.

• The study does NOT need to be a clinical trial for an ITA to be required
  • For example: If an unlicensed Class II, III or IV medical device is used to analyze biological specimens within the context of an observational study an ITA would be required. The device would be likely be classified as an in vitrodiagnostic device(IVDD)
• Software can be considered a medical device
• Medical Device:
  • An instrument, apparatus, contrivance or other similar article, or an in vitroreagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in
    • (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings,
    • (b) restoring, modifying or correcting the body structure of human beings or the functioning of any part of the bodies of human beings,
    • (c) diagnosing pregnancy in human beings,
    • (d) caring for human beings during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
    • (e) preventing conception in human beings;

However, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being

• Classification:
  • Health Canada classifies products based on the intended use established by the manufacturer and how the product is represented at the time of sale.
    • Generally, if a product is clearly labelled, represented and intended solely for educational purposes, it would not meet the definition of a device as outlined in the Food and Drugs Act and therefore, would not be regulated under the Medical Devices Regulations. The labelling (i.e., user manual, Instructions For Use (IFU), promotional material, etc.) should make it abundantly clear that the product is for educational use only and is not intended for professional or clinical use. The product should be represented in a manner which is not misleading or ambiguous.
  • Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1 of the Medical Devices Regulations where Class I represents the lowest risk and Class IV represents the highest risk.
• Sale:
  • If the development, manufacture, and testing of the device are conducted within a single corporate entity, no sale has occurred.
  • The testing must be limited to use on-site (at the corporate entity), and solely by the legal manufacturer.

Effective May 19, 2021, WCH adopted the entire Network of Networks (N2) Standard Operating Procedures (SOPs) set, Version 9. The effective date for research teams may be different depending on when training is completed.

• SOPs should be used for all regulated clinical trials at WCH
  • To view the SOPs, please click here.
  • It is the responsibility of the Qualified Investigator (QI)/Principal Investigator (PI)/Research Team to ensure that training is conducted and documented.
  • To complete training, please click here.
• If the clinical research study is not regulated, it is encouraged to follow the N2 SOPs as closely as feasible for best practice purposes.
• Study teams may grant Sponsors/CROs access to view these SOPs during onsite monitoring visits. Copies of the SOPs are not distributed when onsite CRO/sponsor visits are feasible.
• The N2 SOPs have been developed to reflect a national standardized set of operating procedures that are applicable to any therapeutic area.
• Numerous Health Canada Inspections attest to the fact that those sites using the N2 SOPs are deemed to be compliant with the regulations.
• These SOPs are externally reviewed by an independent expert every two years or sooner. This independent expert has attested in writing that the SOPs are compliant with Health Canada and US Food and Drug (FDA) regulations, the ICH-GCP Guidelines, including the current changes to ICH-E6 (R2) guidelines, and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects.

The Network of Networks (N2) has a number of tools and templates that can be used to support clinical trials. Click here to access – log in and password required.