Medsafe is today announcing a key step in providing quicker access to medicines.
The Associate Minister of Health David Seymour has now finalised the rules needed to put the Government’s ‘rule of two’ verification pathway into practice, which will streamline New Zealanders’ access to new medicines.
Under this pathway, Medsafe can approve a medicine if it has already been approved by two recognised overseas regulators. Instead of repeating the full assessment, Medsafe focuses on verifying those decisions and checking the medicine is the same as the one used overseas, and how it will be used here.
This kind of approach is already used in places like Singapore and the United Kingdom, where regulators work with trusted international partners to fast-track approvals while still maintaining strong safeguards.
Medsafe Group Manager Chris James says the pathway will cut duplication and help speed up access.
‘If a medicine has already met the standards of two trusted regulators, we can focus on confirming those decisions and looking at any New Zealand-specific factors. That means safe, effective medicines can reach New Zealanders sooner.’
Medsafe says feedback from industry and experts helped refine how the pathway will work in practice.
The new rules and supporting regulations are expected to be in place by early July.
The verification pathway is part of broader work by Medsafe to improve timely access to medicines, while maintaining strong safeguards for safety, quality and efficacy.
The Medicines Amendment Act 2025 sets the framework introducing the ‘rule of two’ pathway and the rules published today will now provide the practical detail on how the pathway will operate day to day.
For more information, see Medicines (Consent by Verification) Rules 2026.
