Contributing Lawyers

Canada

Cyndee Todgham Cherniak

United States

Susan Kohn Ross

Australia

Andrew Hudson



Health Canada Starts Second Round of Consultations on Guidelines on Reporting Adverse Pharma Reactions

On January 16, 2008, Health Canada issued revised Guidelines for the Canadian Pharmaceutical Industry on Reporting Adverse Reactions to Marketed Drugs (Vaccines Excluded).  The revised guidelines, when finalized, will replace the 1996 Guidelines and the 2001 revisions.  Health Canada previously consulted with interested parties in October 2006.  This second round of consultations will be open until March 16, 2008.

The following amendments were made as a result of the first round of consultations:

  • All references to the Canadian Adverse Drug Reaction Monitoring Program have been updated to Canada Vigilance to reflect the new program name.
  • Clarification on when reporting obligations commence for domestic and foreign adverse reaction reports has been provided in section 2.1 of the document.
  • Clarification of the foreign adverse reaction reporting expectations (section 2.1.2) have been provided, and apply to market authorization holders for foreign products with the same combination of active ingredients that is also marketed in Canada irrespective of variations in the formulation, dosage form, strength, route of administration or indication.
  • A new section was added on Patient Support and Disease Management Programs (section 4.2.1) and increased information has been provided on solicited reports.
  • Section 4.2.2.1 sets out Health Canada's expectations for adverse reaction reporting involving comparator and concomitant products used in market authorization sponsored studies.
  • The section on the annual summary report has been amended. Information has been provided for both an annual summary report and a Periodic Safety Update Report (PSUR) in accordance with the standards defined in the ICH E2C(R1) guideline.

Interested parties should inform Health Canada whether additional amendments are required.  There may be an opportunity to point out where the proposed measures would be inconsistent with Canada's international obligations under NAFTA, another free trade agreement (with Chile or Israel or Costa Rica or the EFTA Countries) or the WTO Agreements. 

Participate in the consultation process or accept what is coming!

Interested parties should contact Canadian counsel and/or government relations experts (and potentially public relations experts) as soon as possible so that information can be received and response plans developed and completed before the consultation period ends.   

We can put together a team of legal counsel, government relations strategists and public relations consultants depending on the needs of a particular company.

If you would like to review the draft Guidelines for the Canadian Pharmaceutical Industry on Reporting Adverse Reactions to Marketed Drugs (Vaccines Excluded), please click on the following link - http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/medeff/guidance-directrice_reporting-notification_e.pdf

Contact us if you need Canadian advice or assistance:

Cyndee Todgham Cherniak 416-307-4168 (cyndee(at)langmichener.ca)

Michael Flavell or Geoffrey Kubrick or Martin Masse at 613-232-7171 (mflavell(at)langmichener.ca, gkubrick(at)langmichener.ca, mmasse(at)langmichener.ca)

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