Faster Access to Medicines: NZ to Approve Drugs in Under 30 Days via Overseas Standards

The Government says the goal is to increase availability of new, effective treatments by removing regulatory bottlenecks, particularly when safety and efficacy have already been verified by credible authorities overseas.

In a major health sector reform aimed at improving patient access to critical medicines, Associate Health Minister David Seymour has welcomed Cabinet’s endorsement of a new fast-track medicines approval process. The initiative is embedded in the Medicines Amendment Bill, which seeks to modernise and streamline New Zealand’s pharmaceutical approval regime. This marks a pivotal shift in the way medicines are assessed and approved in Aotearoa, aligning the country with leading international practices.

The legislative change, which amends the Medicines Act 1981, will allow new pharmaceutical products to be approved in less than 30 days—but only if they have already received the green light from two recognised overseas regulatory jurisdictions. This streamlined process, dubbed the “Rule of Two,” is expected to be operational by early 2026.

Recognised Countries to Set the Benchmark

The countries currently recognised under the new pathway include Australia, the United States, Canada, the United Kingdom, the European Union, Singapore, and Switzerland—jurisdictions that already play a critical role in shaping Medsafe’s decisions.

“These are the trusted regulators Medsafe currently relies on. By leveraging their assessments, we can bypass unnecessary duplication and reduce delays in patient access to critical medications,” said Mr Seymour.

A Game Changer for New Zealand Patients

“Faster access to medicines has always been a top priority of mine,” said Seymour. “For many New Zealanders, pharmaceuticals represent a matter of life or death, or the difference between a life of suffering and one of comfort and freedom.”

The Government says the goal is to increase availability of new, effective treatments by removing regulatory bottlenecks, particularly when safety and efficacy have already been verified by credible authorities overseas.

Mr Seymour pointed to a recent case involving an asthma treatment that, under the new system, could have been approved as early as late 2022, but instead faced a 16-month delay, only reaching the market in May 2024. “This is exactly the kind of inefficiency we’re fixing,” he said.

Ministerial Powers and Public Feedback

Under the amendments, the responsible Minister will be granted new powers to regulate the implementation of the Rule of Two. This means Minister Seymour will oversee the development of a regulatory framework and introduce it to the public and industry stakeholders for feedback through the Select Committee process.

“The goal is to keep the system as simple and transparent as possible, making it easier for both pharmaceutical companies and patients to navigate,” he said.

Seymour compared the reform to New Zealand’s automotive safety standards. “If a new car is acceptable here because it meets trusted foreign standards, we can apply the same logic to medicines. There’s no need for us to repeat exhaustive testing if the work has already been done by our trusted counterparts.”

Broader Government Moves to Improve Medicine Access

The announcement is just one part of a broader suite of initiatives the Government has introduced to improve New Zealanders' access to medicines. Among these:

• Pharmac process improvements: Regulatory and funding applications can now be assessed in parallel, significantly reducing wait times.

• Historic funding injection: Pharmac has received a record $6.294 billion over four years, including a $604 million budget uplift to support better medicine procurement.

• Increased patient voice: Patients now play a more central role in Pharmac’s decision-making, ensuring that real-life needs are better reflected.

• Pseudoephedrine returns: The once-banned cold medicine ingredient is now back on pharmacy shelves, reversing previous restrictions.

A New Era of Common-Sense Health Policy

Seymour described the reform as a “common-sense efficiency that costs nothing but can save lives.” He emphasized that modernising New Zealand’s pharmaceutical regulatory framework is vital for ensuring the country keeps pace with global innovation and public health standards.

“This Government is focused on outcomes—helping Kiwis live longer, healthier, and more fulfilling lives. Ensuring quicker access to safe, effective medicines is a key part of that vision,” Seymour concluded.

With the Rule of Two set to launch within the next year and a half, industry stakeholders and the public alike are being encouraged to engage in the consultation process. The Government says that New Zealanders deserve faster, smarter access to treatments, and this reform is a major step in that direction.