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Consultation paper on the proposed clinical trial regulatory arrangements under ANZTPA – released for stakeholder consultation

21 February 2007

Please note: This consultation closed on 18 April 2007.

Written submissions were invited on the following consultation paper:

Proposed clinical trial regulatory arrangements under the Australia New Zealand Therapeutic Products Authority (ANZTPA) (pdf,65kb)

Further information about the consultation paper

This consultation paper has been developed to collect the views of stakeholders on the proposed regulatory requirements for clinical trials that are to be administrated under the legislative framework of the Australia New Zealand Therapeutic Products Authority ANZTPA (ANZTPA). Submissions received on this consultation paper will be used to inform the development of the clinical trial guidance documents for ANZTPA, as well as the Managing Director’s Order citing the clinical trials that will require approval via the Clinical Trial Assessment (CTA) route.

URL: http://www.anztpa.org/consult/clintrials.htm