Faster Access to Medicines: New Zealand's Rule of Two and How it Compares to the UK's International Recognition Procedure

In a move welcomed by health professionals and pharmaceutical advocates alike, New Zealand's government has announced the introduction of a Rule of Two – a key regulatory shift designed to accelerate access to medicines. This reform brings New Zealand closer in alignment with international peers like the UK, which has implemented its own expedited process: the International Recognition Procedure (IRP). So, how do these methods measure up against each other?

What is the Rule of Two?

Announced by Associate Health Minister David Seymour, the new Rule of Two allows New Zealand's Medicines Assessment Advisory Committee to consider approvals from trusted overseas regulators when evaluating applications for new medicines. This will allow medicines to be approved in 30 days if they hold approval from two recognised overseas agencies.

This change is included in the Medicines Amendment Bill, which amends the Medicines Act 1981, with the pathway expected to be in operation by early 2026. It marks a significant departure from the previous, more limited process that has often led to delays in patients getting access to new medicines.

With this reform, New Zealand's regulatory authority, Medsafe, can now factor in decisions made by overseas agencies including:

• The US Food and Drug Administration (FDA)
• The European Medicines Agency (EMA)
• Australia's Therapeutic Goods Administration (TGA)
• Health Canada
• Singapore's HSA
• Swissmedic
• The UK's Medicines and Healthcare products Regulatory Agency (MHRA)

The reform is intended to reduce duplication, streamline the evaluation process, and ultimately get life-saving treatments to New Zealand patients faster.

What is the UK's International Recognition Procedure?

Implemented in January 2024, the IRP allows the UK's MHRA to fast-track the approval of new medicines by leveraging the work already done by regulators in other trusted jurisdictions. For more background, see our earlier article on the IRP.

Key Similarities

Both systems share a reliance on a select group of established and trusted regulatory bodies, a focus on reducing the time between overseas approval and local availability, and a risk-based approach that targets medicines with a robust existing evidence base – prioritising efficiency without compromising safety.

Side-by-Side Comparison

Feature	New Zealand's Rule of Two	UK's International Recognition Procedure
Launch Year	2025	2024
Reference Regulator Approval Required	Full MA approval by 2 or more recognised regulators required	Full MA approval by 1 recognised regulator required (conditional/provisional authorisations can also qualify)
Timelines	30 working days after Medsafe's acceptance of an application	Recognition Route A: 60 days; Recognition Route B: 110 days
Restrictions	Must be identical in all material respects to the medicine authorised, with allowance for minor differences. For generics or biosimilars, the innovator or reference product must be identical to that approved for New Zealand.	If the UK reference medicinal product is no longer available, applications under Regulations 51 (generic) or 52 (hybrid) will not be possible and an alternative legal basis will be required. Applications under Regulation 54 (well-established use) are not eligible for IRP.

What This Means for Patients

In both countries, the end goal is the same: quicker access to vital medicines. New Zealand patients have historically waited months – sometimes years – longer than their international counterparts for certain therapies. The Rule of Two helps close that gap.

The details are still to be confirmed; however, it is expected that the application will follow a verification process, with provision for a short clock stop for any questions. As with the IRP, pre-submission discussion of your application is encouraged.

Final Thoughts

New Zealand's adoption of the Rule of Two is a pragmatic and promising shift toward international harmonisation in healthcare regulation. When compared with the UK's IRP, both systems reflect a broader global trend: leveraging international trust to reduce barriers to innovation and improve patient outcomes.

It will be worth watching how these systems evolve – and whether other countries follow suit.