The Regulatory Environment
How clinical trials are governed
There are strict rules for conducting clinical trials governed by two bodies
of the Australian Government Department for Health and Ageing - the Therapeutic
Goods Administration (TGA) and the
National Health and
Medical Research Council (NHMRC).
The TGA is the regulatory body that assesses and monitors the research, manufacture and marketing of any therapeutic goods available in Australia to ensure they are of an acceptable standard. Part of this role is to control ‘pre-market evaluation’ or clinical trials.
Therapeutic goods – including prescription medication such as antibiotics, as well as over-the-counter mediation such as aspirin and complementary medicines such as St John’s Wort - cannot be sold in Australia unless they have been approved by the TGA.
The NHMRC is responsible for allocating Commonwealth funds for health and medical research, considering ethical health issues, and developing guidelines for sensitive medical research activities.
In all our clinical trials, The Wesley Research Institute adheres to the following national and international guidelines and protocols:
