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.
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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