A frequent complaint about the US regulatory system is that manufacturers selling "medicines" need to demonstrate the efficacy of their products to the satisfaction of the FDA, while those selling "supplements" merely need to demonstrate their safety. (I believe the safety standards for supplements may also be somewhat different from those for medicines, but I'm not sure about the details.) Can you comment on how the Australian regulatory system handles this sort of distinction?
The TGA treats complementary 'medicines' and 'supplements' in the same way. They are mostly 'listed', which means they contain pre-approved ingredients assessed for their safety but they aren't assessed for efficacy. Some of them are 'assessed listed', which means they contain pre-approved ingredients assessed for their safety and they go through a pre-market efficacy assessment (but the standards of this efficacy assessment are pretty low - there is some regulatory capture going on here). Finally, some are 'registered', which means they have gone through a stricter efficacy assessment. There are very few registered complementary medicines and they're mainly things like high-dose iron supplements.
A frequent complaint about the US regulatory system is that manufacturers selling "medicines" need to demonstrate the efficacy of their products to the satisfaction of the FDA, while those selling "supplements" merely need to demonstrate their safety. (I believe the safety standards for supplements may also be somewhat different from those for medicines, but I'm not sure about the details.) Can you comment on how the Australian regulatory system handles this sort of distinction?
The TGA treats complementary 'medicines' and 'supplements' in the same way. They are mostly 'listed', which means they contain pre-approved ingredients assessed for their safety but they aren't assessed for efficacy. Some of them are 'assessed listed', which means they contain pre-approved ingredients assessed for their safety and they go through a pre-market efficacy assessment (but the standards of this efficacy assessment are pretty low - there is some regulatory capture going on here). Finally, some are 'registered', which means they have gone through a stricter efficacy assessment. There are very few registered complementary medicines and they're mainly things like high-dose iron supplements.