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--- health_canada [2023/02/13 23:57]
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 ===== History =====
-==== COVID-19 crisis ====
+Prior to the [[COVID-19 pandemic]], Health Canada's website hosted a web portal through which consumers could report suspected adverse events to [[vaccines]].((Health Canada. (2019, December 30). //Report a side effect to a vaccine: consumers.// Government of Canada. http://archive.today/2020.09.20-152607/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/vaccine/consumer.html))
+==== COVID-19 ====
+On December 1, 2020, Health Canada altered their consumer reporting page to remove the ability to submit adverse event reports online. This change meant consumers were forced to submit reports to their healthcare practitioner, who would then fill out a printed form and mail it in.((Health Canada. (2020, December 1). //Report a side effect to a vaccine: consumers.// Government of Canada. http://archive.today/2020.12.27-183130/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/vaccine/consumer.html))
 On June 24, 2022, Health Canada appeared to delete nearly 2,000 “adverse events of special interest,” comprising 28.3% of their total collected of such reports to date.((Tim Truth. (2022, September 4). //Canada Govt DELETES Thousands Of Reported Adverse Events Of Special Interest Pertaining To Hearts, CNS & Autoimmune Disorders.// Substack. https://archive.ph/N4qRl)) This move followed the publication of a pre-print study by [[Peter Doshi]] //et al// reviewing AESIs in the clinical trials by [[pharmaceutical_companies:Pfizer]] and [[pharmaceutical_companies:Moderna]] just one day prior.((Fraiman, J., Erviti, J., Jones, M., Greenland, S., Whelan, P., Kaplan, R. M., & Doshi, P. (2022, June 23).// Serious Adverse Events of Special Interest following mRNA vaccination in randomized trials.// SSRN. https://web.archive.org/web/20220907210255/https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239))
-On July 14, 2022, Health Canada authorized the use of the [[Moderna mRNA-1273|mRNA-1273]] [[COVID-19 vaccines|COVID-19 vaccine]] manufactured by [[pharmaceutical_companies:Moderna]] for children 6 months to five years old.((Health Canada. (2022, July 13). //Health Canada authorizes use of Moderna COVID-19 vaccine in children 6 months to 5 years of age.// Government of Canada. https://web.archive.org/web/20220716004905/https://www.canada.ca/en/health-canada/news/2022/07/health-canada-authorizes-use-of-moderna-covid-19-vaccine-in-children-6-months-to-5-years-of-age.html)) This marked the first such product authorized for that age group in [[Canada]].
+On July 14, 2022, Health Canada authorized the use of the [[mRNA-1273]] [[COVID-19 vaccines|COVID-19 vaccine]] manufactured by [[pharmaceutical_companies:Moderna]] for children 6 months to five years old.((Health Canada. (2022, July 13). //Health Canada authorizes use of Moderna COVID-19 vaccine in children 6 months to 5 years of age.// Government of Canada. https://web.archive.org/web/20220716004905/https://www.canada.ca/en/health-canada/news/2022/07/health-canada-authorizes-use-of-moderna-covid-19-vaccine-in-children-6-months-to-5-years-of-age.html)) This marked the first such product authorized for that age group in [[Canada]].
+On February 28, 2023, Health Canada's consumer reporting page was updated once again, this time restoring the online reporting function and noting that healthcare practitioners are required by law to report adverse events.((Health Canada. (2023, February 28). //Report a side effect to a vaccine: Consumers.// Government of Canada. http://archive.today/2023.05.01-234821/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/vaccine/consumer.html))
 ===== Organization =====
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 The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) regulates biological [[drugs]] (products made from living sources, including [[vaccines]]), [[radiopharmaceuticals]] (drugs that have [[radioactivity]]), and cells, tissues and organs for human use in Canada. The Directorate is also the regulatory authority responsible for the Assisted Human Reproduction (AHR) Act and its supporting regulations.((Health Canada. (2021, June 23). //Biologic and Radiopharmaceutical Drugs Directorate.// Government of Canada. https://archive.ph/DUsZi))
+==== Canada Vigilance Program ====
+Health Canada collects reports of adverse events associated with pharmaceutical products through the [[Canada Vigilance Program]] (CVP).((Health Canada. (2022, June 15). //Canada Vigilance Program.// Government of Canada. http://archive.today/2023.05.09-195237/https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html))
 ==== Staff ====
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   * [[https://web.archive.org/web/20221027082044/https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html#a3.12|Good manufacturing practices guide for drug products (GUI-0001)]]
+  * April 2020: [[https://web.archive.org/web/20230516002719/https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/medeff/report-declaration/ser-des_form-eng.pdf|Side Effect Reporting Form]]
 ===== External links =====
   * [[https://en.wikipedia.org/wiki/Health_Canada|Wikipedia]]
-{{tag>Regulatory_agencies Canadian_government_agencies}}