Regulatory Focus™ > News Articles > Health Canada Expands Use of Foreign Data

Health Canada Expands Use of Foreign Data

Posted 01 October 2012 | By Ansis Helmanis 

Health Canada announced on 28 September the expansion of its pilot project on the use of drug review assessment information from foreign regulatory agencies, such as the European Medicines Agency, in its own marketing authorization review process.  

The Use of Foreign Reviews pilot project was first initiated in October 2011 to test whether access to such data would assist Health Canada in meeting its regulatory assessment "targets" by speeding up the application review process.

The pilot will be extended through 31 March 2013 and expanded to include Notifiable Changes (drugs), Risk Management Plans (drugs), Periodic Safety Update Reports and evidence provided to confirm the continued safety and effectiveness of a marketed product (drugs and medical devices).

In addition, the following data packages will also be included:

  • New Drug Submissions (drugs)
  • Abbreviated New Drug Submissions (drugs)
  • Supplement to a New Drug Submissions (drugs)
  • Supplement to an Abbreviated New Drug Submissions (drugs)
  • Drug Identification Number Applications (drugs)
  • Class III and IV Licence Applications (medical devices)
  • Class III and IV Licence Amendment Applications (medical devices)

Comments on the revised draft guidance may be submitted until 31 March 31 2013.

Read more:

Health Canada - Draft Guidance Document: The Use of Foreign Reviews by Health Canada and revisions to the Use of Foreign Reviews pilot project

Health Canada - Frequently Asked Questions (FAQs) - The Use of Foreign Reviews by Health Canada

Health Canada - Foreign Review Attestation and Summary of Quality Differences: Subsequent Market Entry Products (Human Drugs)

Read all Breaking News from RegLink


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