Call to fast-track animal medicines approval

Animal and Plant Health New Zealand (APHANZ) chief executive Dr Liz Shackleton said that healthy animals benefit communities in many ways and being able to treat them with the best and latest medication matters.

Currently, animal medicines must be approved for use in New Zealand by the Agricultural Compounds and Veterinary Medicines Group within New Zealand Food Safety, and in some instances the Environmental Protection Authority as well.

Under the proposed amendment to the Medicines Act 1981, if a medicine has passed judicial overview and received full approval in two recognised jurisdictions (like Australia, UK, the US) and would not see any unique challenges in the New Zealand environment then approval could be fast tracked in no more than 30 days.

The amendment has passed its first reading in Parliament and, if accepted, would come into effect in mid-2026.

The recent Ministry of Regulation Agricultural and Horticultural Products Regulatory Review recommends increasing the use of assessments by international regulators and supporting harmonisation of requirements.

This would help address regulator resource and prioritisation challenges highlighted in the review report.

Shackleton says that APHANZ members fully support the ‘rule of two’ approach currently being considered for human medicines being applied to some animal medicines.

“This is also an immediate, tangible way for regulators to harmonise and ease workload.

“Our members are unclear why this opportunity has not already been seized.

“We have already provided regulators with options including this one for immediate steps to improve access to veterinary medicines by harmonising New Zealand’s approach where appropriate with trusted international regulators and best practice conventions.

“We look forward to seeing greater harmonisation as part of government agencies’ urgent implementation of the recommendations of the regulatory review.”

In a further statement to Rural News, Shackleton said that striking the right balance between risk and reward was essential as New Zealand regulators do not have the same resourcing levels of larger, trusted overseas regulators.

“We support the need for products for use in New Zealand to be rigorously tested through a trusted process that aligns with international approaches and balances our resourcing practicalities as a small country.

“Many companies are currently deciding their futures here.

“We know of one who has already pulled their investment from New Zealand and others are saying their futures here are untenable without regulatory change. A growing risk we face is not having access to these products at all.

“The Ministry for Regulation review report has reinforced those improvements to the regulatory process is critical and our call for greater harmonisation is a positive step towards this end.

“It is not a free pass as we acknowledge there is no such thing as zero risk, only degrees of risk to be managed.”