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Regulatory Framework * Therapeutic Goods

There are two Australian Federal Government bodies controlling therapeutic goods regulation – the TGA in the Australian Government’s Department of Health & Ageing, and the NHMRC.

The NHMRC is responsible for:

  • allocating Commonwealth funding for health and medical research 
  • considering ethical health issues and
  • regulating sensitive medical research activities.

The TGA regulates:

  • pre-market evaluation
  • access to unapproved medicine
  • licensing of manufacturers
  • post-marketing monitoring and
  • export medicines.

The TGA does not regulate reimbursement of the cost associated with treatments or the role of ethics committees in clinical trials.

The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) 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 on Ethics in Human Research (and therefore not accepted) and that others require explanation in terms of ‘local regulatory requirements’ [refer to the 2008 QCTN Member Directory for further information]. This means that clinical trials conducted in Australia need to comply to the highest international standards.

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