Regulatory Services: Submission and Product Lifecycle Considerations

By Anne Tomalin

Key considerations for submissions and planning, for your product’s lifecycle. Anne Tomalin, Vice President, Quality, Regulatory and Safety at Innomar Strategies talks through costs, data protection and whether an accelerated process is available for product approvals.

Video Transcript:

In Canada we do have a process for accelerated approval. It's called the Priority Review Process. You are required to apply to have your submission given priority review status which means they take it out of line and put it ahead of the other drugs under review.

In order to do that your drug has to treat a condition for which there is no other medication available, or your drug has to be shown to be better than available drugs in a head to head study. In addition, the condition has to be a severely debilitating, or life threatening condition that you are treating.

If you meet those conditions, then you are given a priority review and your submission is reviewed in 6 months instead of 10 months.

So when Canada initially introduced the concept of charging to have an NDS reviewed the concept was to charge the industry for 50% of the cost whereas the public would pick up the other 50%, since the benefit went both to the sponsor and to society as a whole. That resulted in costs of about $300,000-$350,000 for a new chemical entity.

However, since we brought in costs for new drugs the concept has changed, so that sponsors should pay closer to 100% of the cost of having the submission reviewed. So over about a 5-year period of time we are introducing increased costs, up to approximately $700,000, for a new chemical entity review.

So clients frequently ask about data protection in Canada to supplement patent protection. And Canada does have data protection. Our data protection extends for a period of 8 years, but it only applies to new chemical entities.

During the 8-year period of time, for the first 6 years, the generic company cannot file a generic submission and Health Canada cannot issue an approval until 8 years. There is a potential to have that 8 years extended if you submit work dealing with a pediatric application. You can get an additional 6 months of data exclusivity.

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About the Author

Anne Tomalin

Vice President
Quality, Regulatory & Safety
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