Source: New Zealand Government
Annual performance statistics released today show Medsafe following my direction and approving new medicines faster than last year, which was faster than the year before, and there is more to come with the Rule of Two and AI, Associate Health Minister David Seymour says.
“New Zealanders need a smarter, more efficient government which gets things done, enabling them to live better lives,” Mr Seymour says.
“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.”
Medsafe completed its evaluation for innovative medicines 59 working days faster than last year. This is on top of the 55 days reduction in 2023/24.
Generic medicines decisions were 64 days faster than last year, on top of the 45 days reduction in 2023/24.
Medsafe has again met 100% timeframes for over-the-counter medicines, providing certainty for pharmaceutical companies.
“Assessment timeframes for most categories of medicine are now similar to the timeframes required in Australia. We often use compare ourselves to Australia, and in this area we have caught up,” says Mr Seymour.
“The abbreviated pathway is also reducing timeframes. It requires Medsafe to work smarter by leveraging work already done by other overseas regulators. About 50 percent of medicines are assessed like this, and in half the time of the full pathway.
“Medsafe will speed up approval processes further. The Medicines Amendment Bill includes the Rule of Two, which will be in operation by early 2026. The Rule of Two requires Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.
“Last year I wanted Medsafe to find more innovative ways to expedite their approval pathways. One way they have done this is by prioritising new innovative medicines and assessing them under urgency because people need them now.
“Some of these included the Bleriplex medicine for people with blood clotting disorders, the blood cancer medicine Omjjaro, Tyruko for multiple sclerosis, and the Wyost injection for weakened bones due to cancer. For Omjjaro, this meant it was able to be approved 131 days faster than the average time last year for new innovative medicines.
“Earlier this year I wrote to Medsafe asking them to find ways that AI could help the process new medicines faster. This is something that they have welcomed and recognise could reduce assessment times. I look forward to working with Medsafe as they explore this.
“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.”
