For natural health products, when the 53 recommendations came out, they were looking at how natural health products are used. One of the key distinctions legally is that natural health products can be used for the maintenance of good health. That's not something that forms part of the definition of a drug product.
When they studied this issue, they went through all the different ways that natural health products should be regulated, and they were proportionate in determining what to establish for natural health products. They considered very specific requirements: how people use these products, what type of testing should be applied, how frequently facilities should be managed, and who should be working in the directorate that approves these products. They went through and designed 53 recommendations. It's quite robust. The natural health product regulations were designed around that, which is why it was viewed legally for many years as a model for other countries to follow.
When you combine the therapeutic product regulations, what you're essentially doing is applying a regulatory regime that was designed to address very specific gaps that Health Canada had in addressing pharmaceutical drug products. That also includes the fact that the regime was 50 years old. For natural health products, it's a modern regulatory regime, because it was developed in 2004.
