All medicines in Australia, both complementary and
conventional, must be manufactured under pharmaceutical
standards of good manufacturing practice (GMP). All
medicines must be on the Australian Register of Therapeutic
Goods (ARTG) as either listed or registered.
All prescription medicines and the majority of
over-the-counter (OTC) pharmaceutical medicines are
registered and labelled 'AUST R', while the majority of
complementary medicines are listed and are labelled 'AUST
L'. Registered medicines have been evaluated by the TGA for
quality, safety and efficacy, listed medicines have been
similarly assessed - only not for efficacy. Companies making
claims for efficacy however, must hold evidence that
supports these claims. Any high-level claim of efficacy for
a serious disease requires registration and TGA assessment.
In contrast, vitamin, mineral, herbal and other health
supplements in the United States are regulated as dietary
supplements. The U.S. Food and Drug Administration (FDA) is
not involved in the assessment or certification of these
types of products.
This places Australia at the forefront of complementary
medicine regulation and ensures that Australian consumers
have medicines produced at a high level of quality control.
Please contact us for more information.