Links
Below are some links to key areas of policy and guidelines for clinical research in Australia
Clinical Trials Regulatory Requirements in AustraliaThe agency responsible for regulation of unapproved medicines in Australia is the Therapeutic Goods Administration (TGA). The regulations and documents necessary for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial are provided in the TGA document, Access to unapproved therapeutic goods – clinical trials in Australia (October 2004) [PDF]. |
Good Clinical Practice in AustraliaThe Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) [PDF] is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The TGA has adopted CPMP/ICH/135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of 'local regulatory requirements'. |
Ethical Conduct in Australia – “The National Statement”The National Statement on Ethical Conduct in Human Research (2007), is the Australian national reference point for ethical considerations relevant to all research involving humans. |