The Food and Drug Regulations, more specifically sections C.01.016 to C.01.020, C.08.007 (h) and C.08.008 (c), set forth regulatory requirements for manufacturers, including but not limited to, the reporting of adverse drug reactions (ADR) and the reporting of unusual failures in efficacy of new drugs to Health Canada. As part of Health Canada’s mandate to maximize the safety, quality and efficacy of health products, Health Canada implemented on August 1, 2004, an inspection program for Good Pharmacovigilance Practices (GVP) (previously known as Post-Market Reporting Compliance). The GVP inspection program is intended to verify that the manufacturer meets the requirements of sections C.01.016 to C.01.020, C.08.007 (h) and C.08.008 (c) of the Food and Drug Regulations pertaining to ADR reporting. Within the context of the GVP inspection program, Market Authorization Holders (MAH) and importers are subject to GVP inspections as their name appears on the label and as such may receive ADRs.
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.
2.0 Purpose
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.
3.0 Scope
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:
This guide does not currently apply to:
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.
2.0 Purpose
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.
3.0 Scope
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
- radiopharmaceuticals.
This guide does not currently apply to:
- hard surface disinfectants,
- veterinary products,
- natural health products, and
- whole blood and blood components.
Posted by:- Indian Biological Sciences and Research Institute, NOIDA
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