Australia New Zealand
Therapeutic Products
Authority

Information last updated: 18 May 2007
URL: http://www.anztpa.org/new/anzpta-update/
   2007/070518update.htm

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Home | ANZTPA-UPDATE email archive | 18 May 2007
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Update on the ANZTPA Establishment Project

18 May 2007

This email was sent to ANZTPA-UPDATE email list subscribers on 18 May 2007.

Dear Sir/Madam

Recent updates to the Australia New Zealand Therapeutic Products Authority (ANZTPA) Project website are listed below:

Following the release on 24 April 2007 of consultation documents relating to In-Vitro Diagnostic Devices (IVDs) and the Regulation of Human Cellular and Tissue Therapies (HCTs), focus group workshops were held with industry associations and other key stakeholders, in Australia and New Zealand, during the first two weeks of May.

Questions and answers (Q&As) raised during the consultation workshops have been prepared and are available from the links below:

• Questions and answers about In-Vitro Diagnostic Medical Devices (IVDs) as included in the draft Medical Devices Rule <http://www.anztpa.org/devices/qaivd.htm>
• Questions and answers about the Regulation of Human Cellular and Tissue Therapies under ANZTPA <http://www.anztpa.org/bt/qahct.htm>

In addition, copies of the presentations from the IVD and HCT workshops have also been published on the ANZTPA website <http://www.anztpa.org/consult/0705pres.htm>.

These documents have been made available to provide an overview of the documents being considered and to assist stakeholders to prepare written submissions.

Note: The project team would also like to remind stakeholders that submissions on the IVD and HCT consultation documents <http://www.anztpa.org/consult/consdocs3.htm> close on 13 June 2007.