The content of this document should not be regarded as the only interpretation of the Food and Drug Regulations, nor does it intend to cover every conceivable case. Alternative means of complying with the Food and Drug Regulations can be considered with the appropriate justification.
The purpose of this guidance document is to provide interpretive guidance to industry on the expectations of inspectors with respect to the adverse drug reaction and post-approval reporting requirements when conducting GVP inspections. These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements regarding good pharmacovigilance practices.
The Food and Drug Regulations set forth regulatory requirements for manufacturers to report ADRs and to report unusual failure in efficacy of new drugs to Health Canada. Within the context of the GVP inspection program, MAH and importers are subject to GVP inspections as their name appears on the label and as such may receive ADRs.
This guide covers the following drugs marketed in Canada for human use which are subject to GVP inspections:
- · Pharmaceuticals,
- · Biologics, including biotechnology products, vaccines and fractionated blood products,
- · medical gases, and
This guide does not currently apply to:
- hard surface disinfectants,
- veterinary products,
- natural health products, and
- whole blood and blood components.