Update about the project to establish the Australia New Zealand Therapeutic Products Authority
4 April 2007
This email was sent to ANZTPA-UPDATE email list subscribers on 4 April 2007.
Dear Sir/Madam
Recent updates to the Australia New Zealand Therapeutic Products Authority (ANZTPA) Project website are listed below:
- The Exposure Draft of the Australian Therapeutic Products Bill <http://www.health.gov.au/internet/wcms/publishing.nsf/Content/therapeutic-products-lp-1> has been released for stakeholder consultation. This is another significant milestone in the journey towards the establishment of the Australia New Zealand Therapeutic Products Authority. Further information about the Therapeutic Products Bill 2007 can be found on the Department of Health & Ageing website.
- Three draft Orders have been published on the ANZTPA website. Written submissions are invited on the draft Orders listed below. These are the first of many draft Orders, which will be progressively released for stakeholder feedback. To access these consultation drafts click on the link(s) below:
- Draft Order: Medical Device Standards for Clinical Evidence <http://www.anztpa.org/consult/orders/drmdso-clinev.htm>
- Draft Order: Medical Device Standards for Risk Management <http://www.anztpa.org/consult/orders/drmdso-riskmmt.htm>
- Draft Order: Conformity Assessment Standards for Quality Assurance Techniques for Animal Tissues and their Derivatives Utilised in the Manufacture of Medical Devices <http://www.anztpa.org/consult/orders/drcaso-tissues.htm>
Note: The project team would also like to remind stakeholders that submissions on the Consultation Paper: Proposed clinical trial regulatory arrangements under ANZTPA close on 18 April 2007.
URL: http://www.anztpa.org/new/anztpa-update/2007/070404update.htm