New ANZTPA must not derail TGA reforms

The establishment of an Australia New Zealand Therapeutic Products Agency (ANZTPA) must not derail important regulatory reform of the Therapeutic Goods Administration already underway, Medicines Australia’s acting chief executive Andrew Bruce said today.

Renewed negotiations to proceed with the establishment of a joint agency were flagged today by the Australian and New Zealand governments.

“The TGA is part way through its own program of extensive reform which will help ensure Australians enjoy more timely access to new medicines,” Mr Bruce said.

“It is extremely important that those reforms are not adversely impacted or delayed by extra workload associated with establishing ANZTPA,” Mr Bruce said.

“The TGA reforms are in their early stages but are already showing signs of strain due to pressures on resourcing. The Government must ensure that the resource demands of the new joint agency do not impede the progress of a reform agenda whose implementation to date has been patchy.

“The TGA must be properly resourced by Government to take on the additional workload which the implementation of a new joint agency will require.”

Mr Bruce said ANZTPA would provide a single point of entry for the registration of new medicines.

“This is a great opportunity to create a single world-class regulatory agency,” Mr Bruce said.

“We are a global industry and many of our New Zealand affiliates are managed through Australia. We recognise that the New Zealand system needs reform and a joint regulatory agency will deliver that reform.

“As a key stakeholder in regulatory reform, Medicines Australia looks forward to contributing to the new ANZTPA negotiations as we did before the earlier negotiations were suspended in 2007.

“The drive for regulatory harmonisation is an important part of our respective governments’ long-standing Closer Economic Relations policy to reduce trade barriers between Australia and New Zealand across all industries.”


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