Resources and Information
The Role of the Therapeutic Goods Administration (TGA)
In Australia, the Therapeutic Goods Administration (TGA) is the regulating authority and governing body for the approval of new drugs and therapies.
Therefore, any ‘unapproved therapeutic goods’, which are considered experimental are required to make use of a relevant notification scheme. These schemes provide an avenue for lawful access to and supply of products not yet accepted in the general market.
Therefore, any ‘unapproved therapeutic goods’, which are considered experimental are required to make use of a relevant notification scheme. These schemes provide an avenue for lawful access to and supply of products not yet accepted in the general market.
What is the International Conference of Harmonisation (ICH)?
The standard of clinical trials in Australia, are guided by a set of principles and guidelines developed by the International Conference of Harmonisation (ICH). These principles have their origins firmly in the World Medical Association Declaration of Helsinki and exist to protect the safety and rights of all clinical trial participants. The principles advocate the collection of credible and high quality data whilst minimising risk or harm to patients.
The Role of the National Health and Medical Research Medical Council (NHMRC)
In Australia, the National Health and Medical Research Medical Council (NHMRC), play an important role in the conduct of clinical trials.
The NHMRC hold a major role in advising and guiding Human Research Ethics Committees (HREC’s), which are responsible for reviewing the ‘ethical’ and ‘scientific’ aspects of a clinical trial. HREC’s are also responsible for the monitoring of clinical trials once approved.
The NHMRC hold a major role in advising and guiding Human Research Ethics Committees (HREC’s), which are responsible for reviewing the ‘ethical’ and ‘scientific’ aspects of a clinical trial. HREC’s are also responsible for the monitoring of clinical trials once approved.
Accessing Current Clinical Trials
There is no single user friendly source that comprehensively captures all current clinical trial activity in Australia. Patient support groups or online patient communities may have information about trial opportunities and they are increasingly advertised in the media. Conducting an internet search may be helpful or asking your healthcare provider as they may be able to help source information. You can also visit the suggested links below.
