In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and efficacy of products.
The bulletin reminded DEL holders of their obligations to notify or report to Health Canada any events that could have an impact on pharmaceutical operations. Specifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested or stored by the DEL holder. The notification should include a description of the impact on the quality, safety, and/or efficacy of the product. If available at the time of notification, the DEL holder should also disclose any action that has been taken or is planned to address the situation and mitigate the health risk the drug may pose to the consumer
If foreign buildings have been affected by events impacting the supply chain of life-saving medicines, Health Canada will consider expediting the addition of new foreign buildings to DEL holders if the product is medically necessary or the product has been accepted for priority review.
The bulletin also reminds drug authorization holders that the FDR make it mandatory to report drug shortages and discontinuations of sale within the prescribed time frames (i.e., no less than six months in advance if it is likely to begin in more than 6 months, or, within 5 days of becoming aware of the drug shortage or discontinuation of sale if it will begin within 6 months). Further details on reporting drug shortages can be found in the guidance document Guide to Reporting Drug Shortages and Discontinuations.
Finally, clinical trial sponsors must notify Health Canada when there are changes that may affect the quality or safety of clinical trial drug supplies. If a sponsor of an already approved clinical trial is importing clinical trial drug supplies from impacted areas, and changes to the chemistry and manufacturing information become necessary, an amendment (CTA-A) or notification (CTA-N) may be needed, depending on the circumstances. Sponsors may consult the Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications for examples of situations that warrant the filing of a CTA-A or CTA-N.
The bulletin has been circulated to stakeholders, but Health Canada has not yet posted it online.
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