Consultation: Reporting adverse reactions to marketed health products – Draft guidance document for industry – Closed consultation

From: Health Canada

Current status: Closed

This consultation ran from January 25, 2021 to 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a 90-day consultation on the revised guidance draft: Reporting adverse reactions to marketed health products - Draft guidance document for industry.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 was the focus of this consultation

This consultation looked 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Interested stakeholders should read and review the proposed draft guidance document.

Comments on the draft guidance document can be submitted by e-mail to hc.canada.vigilance.sc@canada.ca with the subject heading “Industry Guidance Document – Consultation Comments”.

Feedback received on or before April 25, 2021, will be considered when the draft guidance document is revised.

For awareness

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.

Related information

• Food and Drug Regulations
• Reporting adverse reactions to marketed health products - Guidance document for industry (2018)

Contact us

Canada Vigilance Program
Health Canada
Address Locator 1908C
200 Eglantine Driveway
Ottawa, Ontario
K1A 0K9
Telephone: 1-866-234-2345
E-mail: hc.canada.vigilance.sc@canada.ca