Health Canada is initiating a Pilot Program to assess the compliance of sites defined as lower risk (drugs that are not likely to generate many serious adverse drug reactions) Market Authorization Holders (MAHs). The scheduling of Good Pharmacovigilance Practices (GVP) inspections would utilize a risk-based approach and take into consideration multiple factors such as the product portfolio of the MAH and compliance history.
What to expect?
Health Canada will inform selected MAHs in July 2022 of their inclusion in the pilot program. Selected MAHs will be asked to respond to a questionnaire and provide requested documents by the end of August 2022, which GVP inspectors will review. The questionnaire will be used to assess whether the MAH has adequate procedures and systems. If a MAHs response is deemed unsatisfactory, an inspection will be scheduled between September 2022 and March 2023. Additionally, Health Canada may decide to inspect a certain number of MAHs who provided a satisfactory response.
The results of the questionnaire assessment stage will not be made public. Only the results of regular GVP inspections will be posted.
Please contact us if you have any questions regarding this notice or would like assistance with complying with Health Canada’s GVP requirements.