Regulatory Services: How are products approved?

Video Transcript:

The products are approved in Canada by submitting a New Drug Submission to Health Canada, whether it’s a biologic or a drug, the file is still a New Drug Submission. The login and review period to make sure that the quality of the application is acceptable for receipt is 60 days. And after that there is a 300 day review period for most submissions so generally speaking it's taking a year from the day you submit until the day that you can get approval. Approval is given in a Notice of Compliance in Canada. 

Many clients ask if we have 505-B2 applications and no, we do not. So we have New Drug submissions, and abbreviated New Drug Submissions, but we don't have a 505-B2 which is a submission that relies on a previous decision made by Health Canada.

However even though we don't have a 505-B2 application Health Canada does address products that are being submitted, for example for new indication, by not requiring the data that they've seen and approved many times before, for example the animal data.

So if you're coming from the United States from a GMP perspective clients are usually used to pre-approval inspections, by the FDA, to look at the drug substance manufacturer, the packager, the drug product manufacturer. In Canada we instead have a system of a Drug Establishment License. Drug Establishment Licenses are only given to companies in Canada. You must list every foreign site on your Drug Establishment License. In order to get the foreign site listed you have to prove the good manufacturing practice status of that facility. Usually that's validated through an inspection by a sister regulatory agency such as the FDA.