Clinical trials have to
be approved by a Human Research Ethics Committee (HREC) in order to
comply with the requirements of the National Health and Medical Research
Council (NHMRC). The clinical research approval system is overseen
by the Australian Health Ethics Committee (AHEC).
Therapeutic goods (i.e. medicines and medical devices) are regulated
on a national basis within the framework of the Therapeutic Goods
Act of 1989, compliance of which is overseen by the Therapeutic Goods
Administration (TGA). Therapeutic goods must be approved by the TGA,
and as a rule they have to be listed/registered in the Australian
Register of Therapeutic Goods (ARTG).
If a clinical trial is to be conducted for therapeutic goods that
are not yet entered in the ARTG, the sponsor has to obtain exemption
or approval from the TGA by means of the clinical trial exemption
(CTX) scheme or, more commonly, the clinical trial notification (CTN)
scheme. For such trials there must be an Australian sponsor responsible
for conducting the trial.
 Health
Care System |
| The Australian health
system is a mixture of public and private health service providers.
Government health programmes include Medicare, which is Australia's
universal health insurance scheme, and the Pharmaceutical Benefits
Scheme, which subsidises the cost of many prescription medicines.
Australians can receive free treatment as public patients in
a public hospital. Contribution to the health care system is
made through taxes and a Medicare levy based on income. Private
health insurance can be arranged to cover additional services. |
|
AUSTRALIA
