Regulatory Services: Navigating Clinical Trial applications

By Anne Tomalin |

Anne Tomalin, Vice President, Quality, Regulatory and Safety discusses the clinical trial application processes, Special Access Program (SAP) coordination with Health Canada and the labeling requirements during your clinical trials.

Video Transcript:

In Canada in order to get a clinical trial going it's a little bit different than in the United States. US of course has an IND, but in Canada we're more like Europe. We have clinical trial applications. Each protocol is its own application. You submit and 30 days later you receive a letter of no objection, and then you can start the clinical trial.

So companies frequently ask if they can distribute their product under SAP, or Special Access Program. Special Access Program is like an individual patient approval. You must receive authorization from Health Canada before you can distribute. The physician is required to request it to indicate why they can't use other product available in Canada. And if there's agreement from Health Canada then they may authorise a certain amount of drug to be shipped to that particular patient, and then the supplier can go ahead and ship.

Labels for clinical trial are a little bit different in Canada. Particularly if you're coming from the United States, labels are required to be bilingual. They're required to have the protocol number, and the sponsor name, but another major difference between Canada and the United States is that the relabel or expiry date has to appear on the label. So you will need separate labels for Canada because of the bilingualism, and because of the need for the expiry date.


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About the Author

Anne Tomalin

Anne Tomalin

Vice President
Quality, Regulatory & Safety
Anne Tomalin, BA, B.Sc., joined Innomar in 2018 following the acquisition of TPIreg. With over 40 years of experience in the pharmaceutical industry, she is a recognized leader in Regulatory Affairs, Quality Assurance, and Safety. As the founder and president at TPIreg, she consulted with pharmaceutical companies in Canada and internationally and is a recognized leader and speaker on regulatory, including biological products and rare disease. At Innomar she strategically and operationally leads a diverse team focused on Regulatory Affairs (RA), QA (GMP focused), and Safety (medical information and pharmacovigilance) to optimize client launch planning and operations throughout the product lifecycle.  
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