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Australian Government Response to the recommendations of the review of clinical trials and access to unapproved therapeutic goods (Bansemer Report)
20 November 2006
The following is the consolidated government response to the Bansemer review of access to unapproved therapeutic goods conducted by BanScott Health Consulting Pty Ltd.
The Report made several recommendations, however the principal recommendations include:
- The need for the regulator to develop a clinical trial inspection capability in line with comparable regulatory agencies and the European Directive 2001/20/EC.
- The development of a clinical trials register encompassing at least those trials regulated by the Therapeutic Goods Administration.
- The need for a review and refinement of Human Research Ethics Committee (HREC) review of clinical trial proposals to maximise resources, reduce timelines, and allow for the possibility of a single review for multi-centre research.
- The need for development of a Trans Tasman system for regulatory controls over clinical trials, in anticipation of the Australia New Zealand Therapeutic Products Authority (ANZTPA).
A clinical trials register is currently being piloted at the University of Sydney, funded by a grant from the National Health and Medical Research Council (NHMRC).
Review of the system of HREC consideration of trial proposals has more recently been conducted by a Working Party of the Australian Health Minister's Advisory Council (AHMAC).
A clinical trial system for the forthcoming ANZTPA shall shortly be released for stakeholder consultation as part of the consultation documents surrounding all aspects of operation of the new ANZTPA.
Development and implementation of a clinical trial inspection function shall involve an opportunity for stakeholder consultation and comment at a future date. This will likely occur prior to the commencement date of the ANZTPA such that the system shall be in place at the start-up of the new authority.