Australia has a unique regulatory landscape. Unlike many parts of the world, such as the United States or parts of Europe where they have food products, dietary supplements and then pharmaceutical products, we have a couple of extra categories that lie in between.
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Three categories of regulation
In Australia there’s three major categories of how common health products are regulated.
- listed medicines through the TGA,
- foods through FSANZ, and
- cosmetics with their ingredients regulated through NICNAS.
When considering launching a new product, one of the first things to think about is how is your product going to present? Do you have certain ingredients that you’d like to use in your product? Do you have particular claims that you’d like to make about your product?
Really understanding the direction or the focus for how you want your end product to look helps to work through this process in terms of whether your product will likely be regulated as a food or as a listed medicine.
What determines the regulation of your product?
One of the key things I ask my clients — and I suggest you do it as well — is: what do you want one of your customers to tell a friend about your product?
When you can work backwards from here, you can start to get an idea or some insight into how your product might be regulated.
Imagine that you want your customer to tell a friend that:
- ‘This product really improved my memory’
- ‘I’ve never had so much clarity’
- ‘My stress is the best it’s ever been’
If we work backwards from there then likely your product will end up being listed medicine and will therefore have to go through the TGA regulatory framework to comply with their particular regulations.
It really is important to understand how your product presents, how it will be regulated, and what your specific requirements are so that you can comply.
The importance of complying with the regulations
The regulations in Australia, particularly for listed medicines, are quite strict. If you don’t comply with these regulations you might be fined, your product might be cancelled, it might even be recalled from the marketplace.
These are really the outcomes that you don’t want to have to face.
The more you can do the right thing upfront and make sure that you have a product that people care about, a product that works, a product that’s well priced and a product that makes your company money, the better a position you will be in to do something that really matters.