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ARCHIVED - Consultation: DRAFT Guidance for Industry - Submission of Risk Management Plans and Follow-up Commitments

Warning This content was archived on May 27, 2014.

Archived Content

Information identified as archived on the Web is for reference, research or recordkeeping purposes. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats on the "Contact Us" page.

Notice to the reader: The online consultation is now closed.

Comments will be considered in the finalization of the draft guidance. Additionally, this document is part of a broader patient safety risk management framework. In this regard, it is an evolving consultation that will reflect present and future initiatives, such as regulatory, policy and operational changes to support improved patient safety.

The measures outlined in this guidance are effective immediately since they do not impose an obligation but rather provide options for submission to manufacturers.

Background

As an official observer to, and active participant in the International Conference on Harmonisation (ICH), Health Canada is committed to the adoption and implementation of ICH guidances.

In February 2009, Health Canada adopted and implemented the ICH E2E Guideline by publishing the Notice Regarding Implementation of Risk Management Planning including the adoption of International Conference on Harmonisation (ICH) Guidance Pharmacovigilance Planning - ICH Topic E2E.

In Canada, the European Union (EU) format represents an acceptable approach to fulfilling requests by Health Canada for Risk Management Plans. However, Health Canada will accept RMPs in other recognized formats provided that they include all the essential elements of the EU RMP.

Objective

The objective of this document is to provide guidance to manufacturers on how to proceed when submitting Risk Management Plans RMPs and follow-up commitments with Health Canada. The principles and practices outlined in the document apply to pharmaceuticals, biologics and biotechnology-derived products for human use, within the scope of ICH E2E. The submission of RMPs for natural health products, medical devices (except when they are part of a combination product submission) and veterinary products are outside the scope of this guidance document.

Consultation Document

To obtain an electronic copy of the document, DRAFT Guidance for Industry - Submission of Risk Management Plans and Follow-up Commitments, please send an email to mhpd_dpsc.public@hc-sc.gc.ca with the subject heading "Comments: Risk Management Plan" or contact the Marketed Pharmaceuticals and Medical Devices Bureau.

This consultation is open from March 26, 2014 to May 26, 2014.

Reporting to Canadians

For additional information, contact the Marketed Pharmaceuticals and medical Devices Bureau, Marketed Health Products Directorate.