Although the much-anticipated Medical Products Bill is not yet available, we do have some good news. On 10 April 2025, the Medicines Amendment Bill (Bill) passed its first reading in Parliament. 

Introduced by Associate Health Minister David Seymour, the Bill is designed to speed up New Zealanders’ access to safe, effective medicines already approved overseas, while also making practical updates to prescribing rights. If this Bill comes to fruition, it will align New Zealand with many other global medicine regulators who have adopted "regulatory reliance" for approving new medicines.

New verification pathway – “Rule of Two"

While Medsafe already has some ability to use data from overseas regulators when approving new medicines, the approval process in general has been perceived as very slow - sometimes taking up to 400 working days. Under the new verification pathway, if a medicine has already been approved by two recognised overseas regulators^[1], Medsafe will be able to grant approval within 30 working days (excluding any delays while waiting for additional information from the applicant), removing the need for conducting its usual full assessment. However, additional secondary legislation will be required to establish the specific rules for the pathway, such as eligibility criteria.

What else is changing?

The Bill also makes changes to the exemption that allows medical practitioners to supply unapproved new medicines without going through the usual approval process. Currently, under section 29 of the Medicines Act, doctors can use unapproved medicines to treat individual patients in their care in certain circumstances. The changes will extend this same flexibility to nurse practitioners as well.

In addition, a new exemption will allow authorised prescribers^[2], such as a registered midwife, to prescribe certain unapproved medicines more easily if they are listed by Pharmac as substitutes for approved medicines that are temporarily unavailable. These are called “funded alternative medicines.” This change is designed to help maintain access to treatments during medicine shortages.

Our thoughts

The current government has been all about fast tracking approval processes across various industries, and it is good to see this being worked on in the medicines space. 

While Medsafe approval is not the only pre-requisite for improving Kiwis’ access to new medicines, funding being another key pre-requisite, without a doubt a reduction of approval timeframe from 400 working days to 30 working days should result in more medications being available in New Zealand faster - likely reducing compliance costs for manufacturers as well.

With the ACT Party, New Zealand First, and the National Party all having campaigned on the Bill prior to the election in 2023 - and its inclusion in each of their coalition agreements - the Bill’s progression through Parliament seems highly likely.

Next steps

The Bill has been referred to the Health Committee, with a report due back by 11 August 2025. The government will likely seek feedback on the Bill through the Select Committee process, with dates to be confirmed. In the meantime, we will be closely monitoring the progress of the Bill. 

Get in touch

If you would like to discuss any aspect of the Bill, please contact one of our experts.

Thanks to James Burnett for helping with this article.