Regulatory compliance: Navigating the Canadian landscape for specialty products
By AmerisourceBergen
Navigating the Canadian regulatory landscape for specialty products can be complex. Are you prepared? In this video, Brenda Gryfe, Director Regulatory Affairs, details the regulatory considerations that can make or break your entry into Canada’s pharmaceutical market — including critical data requirements and adapting foreign dossiers for this market.
The contents of this piece contain marketing statements and do not include business or legal advice.
Transcript of ‘Regulatory compliance: Navigating the Canadian landscape for specialty products’
What are some regulatory considerations for specialty products in Canada?
As you know, most new products are actually launched in the US and in Europe before they get to Canada. And even though overall requirements are in alignment with the International Conference on Harmonization, ICH, there are some Canadian unique requirements, which could create some challenges if you're not familiar with them - things like special data requirements, for example, master batch records. Unlike in the US though, one of the biggest differences is that in Canada, a sponsor cannot rely on the information provided by another company to Health Canada. So, unless you have permission from the originator, you have to rely on what information is in the public domain. If you don't have the expertise, if you're new to Canada, we can certainly provide some help, whether it's adapting a foreign dossier for Canada or finding and helping to address any gaps that might be in that foreign dossier, and providing any other services that you may need. And we're excited to help sponsors like yours to bring these drugs to the Canadian market.
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