A 90-day consultation period is underway to all impacted stakeholdersFootnote 1 to provide input on a revised draft guidance for reporting of adverse reactions to marketed health products, says Health Canada.
The agency has noted that in order to support compliance with the Food and Drug Regulations, it has recognised that "it is important for health product manufacturers to understand the regulatory requirements for adverse reaction reporting". The guidance document, entitled Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry, is intended "to help clarify and specify these reporting requirements", added Health Canada.
The guidance was last published in 2018, and since then, the agency has identified several elements of the document that required updates to further clarify requirements for reporting of adverse reactions.
Comments on the draft guidance document can be emailed to Health Canada's "Canada Vigilance Program" (email@example.com) and will be considered during revision if received on or before 25 April 2021.
including marketing authorisation holders, health product manufacturers, and other interested stakeholders.
Health Canada. Consultation: Reporting adverse reactions to marketed health products - Draft guidance document for industry. Internet Document : 25 Jan 2021. Available from: URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medeffect-canada/
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Health Canada launches consultation period for revised draft guidance. Reactions Weekly 1841, 3 (2021). https://doi.org/10.1007/s40278-021-90505-2