- Hon David Seymour
Associate Health Minister David Seymour says that Medsafe’s annual performance statistics released today show that Medsafe are accelerating their approval process.
“The data produced in Medsafe’s annual statistics show that in 2023/2024 Medsafe expedited their assessment process for almost every category of medicine,” says Mr Seymour.
For innovative new medicines (the highest risk category), on average, Medsafe completed their evaluation 55 working days faster than the previous period.
For generic medicines (intermediate risk), on average, Medsafe completed their evaluation 45 working days faster than the previous period.
Medsafe has also adopted new categories for over-the-counter medicines (low risk) which includes pseudoephedrine. For this category Medsafe are meeting 100% of their timeframe targets.
“While faster assessment times is a good step in the right direction, to give Kiwis the medicine access they deserve, Medsafe’s approval process needs further streamlining”, says Mr Seymour.
“One-way Medsafe can streamline their process further is by continuing to go outside of the box and using bespoke processes for approval where suitable.
“An example of where a bespoke process was very successful, was in the approval process of pseudoephedrine following the law change to allow purchase from a pharmacist without a prescription. Medsafe used a risk-based process to determine whether the medicine met their standards for consented low risk medicines. That process saw Medsafe approve 11 low risk products in 15 working days, just in time for winter. We hope to see more of this speed.
“The ACT-³Ô¹ÏÍøÕ¾ coalition document commits to further streamline approval processes by introducing a new verification pathway. These changes will require Medsafe to approve new pharmaceuticals within 30 days of them being approved by at least two overseas regulatory agencies recognised by New Zealand.
“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.”
Note to editors: Please find a link to the Ministry of Health’s landing page for performance reports here:
