Category Archive: Health Canada

Jun 19 2017

What's New Health Canada? April – May 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html   Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php   Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html   Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html     Health Canada New Guidance Documents (Drugs and Biologics)   Health Canada Guidance Type Date Posted Guidance …

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Apr 24 2017

What’s New Health Canada? March – April 2017

By Sandra Salem, Ph.D., Regulatory Scientist, Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada   What’s New in: Therapeutic Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-eng.php   Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php   Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php   Natural and Non-prescription Health Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php     Health Canada …

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Jan 18 2017

What’s New Health Canada? Jan 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada   What’s New in: Therapeutic Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-eng.php Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php Natural and Non-prescription Health Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php     Health Canada New Guidance Documents (Drugs and Biologics): October – …

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Jan 04 2017

Transparency Initiatives at Health Canada

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy for Cato Research Canada. As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php), Health Canada has committed to provide greater transparency and openness to further strengthen trust in their regulatory decisions. The Framework will: Help Canadians to better understand how and why decisions are …

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Nov 19 2012

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada’s Drugs Directorate that analyzed the need for an …

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Oct 04 2011

Health Canada Increases Acceptance of eCTD Electronic-only Filings

Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier this year), HC will now also accept these submission types: Request for Priority Review Status: …

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Jul 20 2011

Choose Canada for Your Next Clinical Trial

When it comes to the state of the life science industry in Canada, the critics are numerous.  The past two to three years have been difficult and those that lie ahead are still quite uncertain.  With the growing competition at various levels from emerging countries, it is crucial to not only assess our weaknesses but …

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Jun 01 2011

Health Canada Expands Acceptance of eCTD Submissions

Image via cellularhealthcanada.com Last week, Health Canada (HC) issued a Notice to to announce an increase in the types of submissions being accepted by the regulatory authority in the eCTD electronic-only filing format.  Effective immediately, HC now also accepts two new submission types in the eCTD electronic-only filing format: Notifiable Changes (NC) Responses to Clarifaxes …

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Sep 23 2010

Download the Regulatory Compliance Webinar Slides

Earlier today, Cato Research hosted a webinar titled, “Regulatory Affairs and Compliance: Common Sources of Deficiencies Identified by the Regulatory Authorities in the United States and Canada.” For those of you who are interested, the slides from Dr. Sheppard‘s presentation are now available for download here (PDF file). Related articles: Free Webinar – Regulatory Affairs …

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Sep 17 2010

Free Webinar – Regulatory Affairs and Compliance

Join Cato Research for a free educational webinar on Thursday 23 September 2010 at 2PM EST. Cato Research Scientist Catherine Sheppard will be presenting “Regulatory Affairs and Compliance: Common Sources of Deficiencies Identified by the Regulatory Authorities in the United States and Canada.” There are many fundamental differences in the regulatory processes and options available …

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