Industry comments on ANZTPA’s joint framework

AusBiotech has made a submission on behalf of the biotechnology industry to the Australia New Zealand Therapeutic Products Agency’s (ANZTPA) discussion paper.

AusBiotech has made a submission on behalf of the biotechnology industry to the Australia New Zealand Therapeutic Products Agency’s (ANZTPA) discussion paper: ANZTPA implementation - Release of high level description of a possible joint regulatory scheme.

Through the consultation process, the Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) requested comment to help inform the development of the regulatory framework for ANZTPA, a joint trans-Tasman agency with responsibility for regulating therapeutic products across both countries.

AusBiotech commented on:

• 3rd Party Conformity Assessment
• Change in regulatory burden in New Zealand
• Transition periods
• Resource implications
• Clinical trials (CTN/CTX scheme)
• Product approvals
• In vitro diagnostics (risk classification and access for home-use)
• Clarification on exemption for blood and blood components
• Clarification on the use of biologicals within IVDs

The full AusBiotech submission can be found here.

The discussion paper can be found here.

Enquires regarding the AusBiotech submission may be directed to Alina Tooley, National Manager Programs or on +61 3 9828 1425.