Medsafe's Verification Pathway ("Rule of Two"): A New Opportunity for Faster Market Access in New Zealand

The Rule of Two introduces a reliance-based approval pathway, allowing Medsafe to approve medicines that have already been authorised by two recognised overseas regulators, within a 30 working day evaluation timeframe.

Recognised regulators include major agencies such as the Food and Drug Administration (US), European Medicines Agency (EU), Therapeutic Goods Administration (AU), Medicines and Healthcare products Regulatory Agency (UK), Health Canada, Health Sciences Authority (Singapore), and Swissmedic.

Rather than conducting a full independent evaluation, Medsafe focuses on:

• Verifying the existing approvals
• Confirming the product is equivalent to that approved overseas
• Assessing any New Zealand-specific considerations

This model aligns New Zealand with global trends toward regulatory reliance, reducing duplication and enabling faster patient access.

• Potentially faster market entry
• Better alignment with global launch sequencing
• Reduced regulatory duplication
• More efficient use of internal resources
• Earlier patient access

 To qualify for the verification pathway, sponsors must meet the following criteria:

• Two prior approvals from recognised regulatory authorities granted within the last four years
• The New Zealand product must be identical in all aspects to the approved overseas versions
• Has not been rejected, withdrawn, or subject to any regulatory action for any quality, safety, or efficacy concerns
• No requirement for a full benefit–risk reassessment in the local market

Historically, the approval process challenge in New Zealand was clear – lengthy, duplicative approvals despite prior global authorisations. Sponsors were often required to undergo a full or abbreviated evaluation, resulting in approval timelines far beyond the proposed 30-day evaluation time for the new pathway, and in some cases,  multiple rounds of regulatory questions, even where comprehensive assessments had already been completed by leading international authorities.

This created a consistent set of frustrations:

• Delayed access for patients compared with other markets
• Misalignment with global launch sequencing
• Increasing internal pressure to justify timelines and resource allocation
• A sense that effort was being duplicated rather than leveraged

The Rule of Two is designed to address exactly these issues by enabling reliance on decisions from trusted regulators and reducing unnecessary reassessment. It has the potential to significantly reduce approval timelines and streamline market entry.

Successfully leveraging the Rule of Two requires more than awareness: it demands early alignment across global, regional, and local teams.

In practice, this means:

• Assessing eligibility well before submission
• Aligning global dossiers and approvals to meet verification criteria
• Assessing product comparability, labelling, and regulatory history early
• Coordinating submission timing across jurisdictions

Without this level of integration, the pathway’s advantages can be lost in execution, leaving sponsors effectively operating under the same timelines and constraints as before.

The Medsafe Rule of Two pathway has the potential to accelerate market entry and reduce regulatory complexity, but realizing those benefits requires careful planning and execution. Sponsors who assess eligibility early, align global and local regulatory strategies, and proactively address submission requirements are best positioned to take advantage of the pathway’s accelerated timeline.

Commercial Eyes works with sponsors to identify opportunities, overcome potential barriers, and develop practical regulatory strategies that support both approval and broader business objectives. Our team can help you:

• Assess Rule of Two eligibility early in development and pre-submission planning
• Determine the most appropriate regulatory pathway for your product and objectives
• Align global dossiers, approvals, and submission timelines to meet pathway requirements
• Manage end-to-end submissions and regulatory authority interactions
• Identify and mitigate potential risks that could delay approval or impact eligibility

Drawing on extensive experience across prescription medicines, generics, biosimilars, OTC products, medical devices, and combination products, we help sponsors navigate regulatory complexities with greater confidence and efficiency.

As part of ProductLife Group’s global network, we can also assess New Zealand’s role within your broader market expansion strategy. By collaborating with our international colleagues, we help sponsors evaluate launch sequencing opportunities and develop coordinated regulatory plans that support both local and global objectives.

Accelerated approval only creates value when it leads to successful market access and patient impact. Bringing a product to market requires coordination across regulatory, commercial, quality, and patient-focused activities.

Through Commercial Eyes and ProductLife Group, sponsors can access support across the product lifecycle, including:

• Market access and reimbursement
• Early access and patient support programs
• Launch readiness and lifecycle management
• Quality systems set up and support
• Pharmacovigilance and medical information

The Medsafe Rule of Two is a significant opportunity aiming to accelerate access to the New Zealand market. Sponsors who plan early align strategically. and execute effectively will be best positioned to realise its benefits and gain a competitive advantage.