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OT - Bit of a curly one - bringing herbs into Oz 10-Mar-2011 At 5:22:35 PM Duncan

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On 10/03/2011 Andrew_M wrote:
>Regulatory approval in Australia for this sort of thing - ie "herbal extracts"
>etc is actually very very murky. I come from a hard science background
>but at one point I somehow got involved quasi-pharma-type company and had
>to deal very similar issues - particularly TGA guidelines. It was a long
>time ago, but if I remember the rightly extracts from plants come in under
>a different classification than manufactured "drugs" - something more akin
>to foodstuffs.

Aren't they referred to as nutraceuticals? I seem to remember there was a medium sized company that went bust 5-10 years ago after it was found that they weren't fulfilling regulatory requirements for making that sort of thing? The TGA does have some form of regulations in place anyway.

>To make a claim that something has an effect (ie is a "drug"), you actually
>need to take it formally through a registration procedure that costs mega
>huge bucks (preclinical trials, then phase I-IV clinical trials). For herbal
>extracts, so long as you don't make official claims they can be sold pretty
>much without restriction. However, there it is entirely possible that these
>herbal extracts CAN have biological (ie "drug") effects, it's just that
>they haven't been PROVEN do do so (and be safe) via this process. In fact,
>that was my biggest concern at the time - the company management always
>wanted to push the envelope - and some of these extracts could potentially
>have significant biological activity, including major side effects - particularly
>if they were highly concentrated.
>
>There is actually a whole mainstream branch of drug research called Ethnopharmacology,
>which looks at cultures all around the world and what traditional remedies
>they use, sees if these remedies actually work, then to tries to isolate
>the active ingredients. Just two historical examples: aspirin started as
>a traditional extract of willow bark, and the most effective antimalarial
>drug that exists at the moment was originally a traditional chinese herbal
>remedy for malaria - artemisinin - it is still made by extracting from
>the herb.

In Sydney, I know UTS and UWS at least are pretty involved in traditional Chinese medicine research.