Medsafe Speeds Up Medicine Approvals as Govt Pushes Rule of Two and AI

“Faster access to medicines matters to patients. For many New Zealanders, pharmaceuticals are life or death, or the difference between a life of pain and suffering or living freely,” Seymour said.

Annual performance statistics released today show that Medsafe, New Zealand's medicines and medical devices regulator, is accelerating the pace at which new medicines are approved—delivering faster outcomes for patients who depend on timely access to life-saving treatments.

Associate Health Minister David Seymour welcomed the progress, noting that the improvements reflect his direction for a "smarter, more efficient government" that can deliver tangible benefits to New Zealanders.

"Faster access to medicines matters to patients. For many New Zealanders, pharmaceuticals are life or death, or the difference between a life of pain and suffering or living freely," Seymour said.

Major Reductions in Approval Times

The data shows substantial reductions across multiple categories of medicines:

• Innovative medicines: Evaluations were completed 59 working days faster than last year, building on a 55-day reduction in 2023/24.

• Generic medicines: Approval times fell by 64 working days compared to last year, adding to a 45-day reduction the year before.

• Over-the-counter medicines: Medsafe again achieved 100% compliance with approval timeframes, ensuring predictability for pharmaceutical companies.

Seymour highlighted that New Zealand's assessment timeframes for most medicines now align closely with those in Australia, a country New Zealand often compares itself against for health sector benchmarks.

Leveraging Smarter Pathways

Medsafe has increasingly relied on its abbreviated pathway, which allows the regulator to use assessments conducted by trusted overseas authorities. This pathway has become a game-changer, with about 50% of medicines now assessed this way, cutting approval times by half compared to the traditional full assessment.

"Assessment timeframes for most categories of medicine are now similar to the timeframes required in Australia. We often compare ourselves to Australia, and in this area we have caught up," Seymour said.

Rule of Two: A New Step Change

Looking ahead, the Medicines Amendment Bill will introduce the Rule of Two, which is expected to come into effect by early 2026. This reform will significantly streamline the approval process by requiring Medsafe to automatically approve new medicines within 30 days, provided that the pharmaceutical has already been cleared by at least two overseas regulatory agencies recognised by New Zealand.

According to Seymour, this will prevent unnecessary duplication of work, speed up patient access, and ensure that New Zealanders can benefit from global medical advancements without facing excessive delays.

Innovative Medicines Fast-Tracked

Medsafe has also prioritised medicines with urgent patient need, accelerating their review process. Some notable examples include:

• Bleriplex – a treatment for blood clotting disorders.

• Omjjaro – a blood cancer medicine that was approved 131 days faster than the average timeframe for innovative medicines last year.

• Tyruko – for patients living with multiple sclerosis.

• Wyost injection – used to strengthen bones weakened by cancer.

These medicines were prioritised under urgency because of their immediate impact on quality of life and patient outcomes.

Exploring Artificial Intelligence in Regulation

In addition to legislative changes, Seymour has asked Medsafe to explore the use of artificial intelligence (AI) to further improve efficiency. Earlier this year, he wrote to the regulator encouraging them to assess how AI could help streamline processes and reduce workloads.

Medsafe has welcomed the directive, recognising the potential of AI to support faster assessments by handling technical reviews, cross-checking regulatory documentation, and reducing duplication. While still in its exploratory phase, the move signals a forward-looking approach to modernising medicine regulation.

Commitment to Patient Access

Seymour emphasised that the Government's broader health reforms aim to ensure regulation does not become a bottleneck. "We're committed to ensuring that the regulatory system for pharmaceuticals is not unreasonably holding back access. We want it to lead to more Kiwis being able to access the medicines they need to live a fulfilling life, not less," he said.

The improvements represent a significant shift in New Zealand's approach to pharmaceutical regulation—one that is increasingly prioritising patient access, international alignment, and innovation.

Looking Ahead

With faster approval times already in place, the upcoming Rule of Two and the integration of AI tools are expected to deliver further efficiency gains. If fully implemented, these reforms could put New Zealand among the world leaders in regulatory agility, ensuring Kiwi patients no longer wait longer than necessary for treatments that are already available overseas.