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Health Canada to Post GMP Inspection Results Beginning April 1, 2015

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Life Sciences Bulletin

Following the recent amendments to the Food and Drugs Act contained in Bill-17, Health Canada has announced that it will begin posting summaries of all Good Manufacturing Practice (GMP) inspections to its website on April 1, 2015.  This move follows the initial release of the GMP inspection lists for 2012-2014 by Health Canada late last year.  Prior to this, GMP inspections were largely a private matter between Health Canada and stakeholders, with information relating to inspections made available to the public only through a formal request under the federal Access to Information Act.  This initiative is part of Health Canada's broader Openness and Transparency initiative, and together with the new investigative powers established in Bill C-17, marks a substantial change in Health Canada's approach to compliance and enforcement.

The new approach to publicizing GMP inspection results was announced in a letter to stakeholders on February 17, 2015, which emphasized the responsibilities and obligations of Drug Establishment Licence (DEL) holders, which include stakeholders who fabricate drug products (including API), or who package/label, test, wholesale, distribute or import drugs for sale in Canada.   Health Canada also served notice of its overall intention to increase the frequency of planned and unplanned inspections, as well as unplanned onsite visits for the purposes of compliance verification, and specifically highlighted several areas of concern based on recent inspection activities, including supply chain integrity (traceability), vendor qualification, cleaning validation, data integrity and packaging conditions.  The level of detail that Health Canada will include in the new GMP inspection summaries, including the extent to which Health Canada will exercise its new power to disclose confidential business information under Bill C-17, is not described.

In connection with this announcement, Health Canada also rolled out its new Inspection Tracker web-based tool, which provides a snapshot of the potential company specific health and safety issues Health Canada is currently tracking.  Current as of February 27, 2015, the Inspection Tracker lists ongoing GMP compliance and enforcement activities/observations involving 14 drug companies operating in Canada.  According to Health Canada, the Inspection Tracker will be updated on a regular basis, and the information in the Inspection Tracker will expand to eventually include details about affected products. 

All stakeholders in the drug product supply chain that are subject to GMP inspections should take note of these new transparency initiatives by Health Canada, as a finding of non-compliance in connection with a GMP inspection will now be a matter of public record.

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