Consultation: Reporting adverse reactions to marketed health products – Draft guidance document for industry
Current status: Open
Open January 25, 2021 and close to the new input on April 25, 2021.
Health Canada is announcing a 90-day consultation on the revised guidance draft: Reporting adverse reactions to marketed health products - Draft guidance document for industry. The purpose of this consultation is to obtain input on the updated guidance document from all impacted stakeholders.
Health Canada recognizes that, in order to support compliance with the Food and Drug Regulations, it is important for health product manufacturers to understand the regulatory requirements for adverse reaction reporting. The purpose of the guidance document, Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry, is to help clarify and specify these reporting requirements.
Since the guidance was last published in 2018, Health Canada has identified several elements of the guidance that require updates to further clarify adverse reaction reporting requirements.
You are invited to comment on the proposed updates to ensure they are clear and relevant and support understanding of the regulatory reporting requirements for industry.
Who is the focus of this consultation
This consultation is looking for feedback from all interested Canadians, in particular:
- Market authorization holders
- Health product manufacturers
- Other interested stakeholders
How to participate
Interested stakeholders should read and review the proposed draft guidance document.
Comments on the draft guidance document can be submitted by e-mail to firstname.lastname@example.org with the subject heading “Industry Guidance Document – Consultation Comments”.
Feedback received on or before April 25, 2021, will be considered when the draft guidance document is revised.
When we publish the final guidance, it will have a new look. New publishing practices are coming to make the content easier to use. The messaging will not change, only the presentation.
- Food and Drug Regulations
- Reporting adverse reactions to marketed health products - Guidance document for industry (2018)
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