Articles

EMA Stability Guideline Rev.3: Post-Approval Variations

f.nichetti@lifebee.it — Wed, 23 Sep 2026 04:00:00 GMT

"Regulatory Compass | Navigating Global Markets" is PLG's ongoing series of expert insights from our regional regulatory affairs teams. Each article draws on direct field experience to help pharmaceutical companies anticipate challenges, make informed decisions, and accelerate their path to market - wherever in the world they operate.

The European Medicines Agency (EMA) has introduced Revision 3 of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation (EMA/CHMP/QWP/441071/2011 Rev.3), effective from 15 January 2026.

TGA GMP Non-Compliance: How Sponsors Should Respond

f.nichetti@lifebee.it — Wed, 16 Sep 2026 04:00:00 GMT

For many Australian Sponsors, GMP compliance is primarily managed through oversight of their manufacturing partners. However, when the Therapeutic Goods Administration (TGA) issues a GMP non-compliance notification, Sponsors can quickly find themselves managing an urgent and resource-intensive regulatory response.

Clinical Trial Quality: Building Trust in Clinical Evidence

f.nichetti@lifebee.it — Wed, 16 Sep 2026 04:00:00 GMT

Trust does not appear in the results. It is built long before they are published.

A misplaced biological sample. An adverse event not reported on time. A deviation in the dispensing of an investigational medicinal product. A critical data point entered incorrectly.

GCC Regulatory Readiness: Is Your EU Dossier Ready?

f.nichetti@lifebee.it — Tue, 15 Sep 2026 04:00:00 GMT

"Regulatory Compass | Navigating Global Markets" is PLG's ongoing series of expert insights from our regional regulatory affairs teams. Each article draws on direct field experience to help pharmaceutical companies anticipate challenges, make informed decisions, and accelerate their path to market - wherever in the world they operate.

A European approval is a valuable regulatory asset. It demonstrates that a product has successfully met rigorous standards for quality, safety, and efficacy.

Ashwagandha Regulatory Landscape for Food Supplements

f.nichetti@lifebee.it — Fri, 11 Sep 2026 04:00:00 GMT

"The rules for botanicals are changing - and Ashwagandha is the clearest signal."

The regulatory landscape for botanical ingredients is undergoing a significant transformation. Traditional use, once considered a strong indicator of safety, is no longer sufficient as a stand-alone justification for modern dietary supplements. Modern regulatory aspirations for supplements alter traditional context through concentrated extracts, product specific evidence, and target consumer groups.

FDA Mandatory GRAS Notification: Proposed Rule

f.nichetti@lifebee.it — Thu, 10 Sep 2026 04:00:00 GMT

The FDA has proposed a significant change, transitioning from a voluntary notification programme to a mandatory requirement for substances that are deemed to be generally recognized as safe (GRAS) under section 201(s) of the FD&C Act. The aim of this rule (91 FR 51834) is to eliminate 'information gaps' caused by ingredients entering the US market without federal oversight.  

Five Years of Regulatory Science: 10 Key Publications

f.nichetti@lifebee.it — Tue, 08 Sep 2026 04:00:00 GMT

Bringing a new medicine to market is as much a regulatory challenge as a scientific one. Understanding how agencies like the European Medicines Agency (EMA) actually evaluate evidence - not just what the guidelines say, but how decisions play out in practice - is where regulatory strategy is won or lost.

Asian Evidence for EU Marketing Authorisation

f.nichetti@lifebee.it — Wed, 02 Sep 2026 04:00:00 GMT

An increasing number of novel molecular entities and biosimilars reach the European Medicines Agency (EMA) supported by pivotal evidence derived predominantly from Asian patient populations - a pattern the existing ICH E5 framework was not originally designed to address. For pharmaceutical companies based in Asia looking to expand into Europe, understanding how the EMA actually assesses this kind of evidence, rather than assuming it, is becoming a critical part of regulatory strategy.

ProductLife Group's Move for Health Access

f.nichetti@lifebee.it — Thu, 27 Aug 2026 04:00:00 GMT

Earlier this summer, ProductLife Group employees set out to cover 3,000 kilometres together. By the time the challenge closed, they had covered 8,950.6 kms.

Medsafe Rule of Two: Faster Market Access in New Zealand

f.nichetti@lifebee.it — Mon, 03 Aug 2026 04:00:00 GMT

For sponsors seeking faster access to the New Zealand market, Medsafe's new Verification Pathway, also known as the "Rule of Two" could significantly reduce approval timelines and simplify regulatory strategy. By leveraging approvals already granted by trusted international regulators, companies can accelerate market entry, reduce duplication, and better align New Zealand with global launch plans.

What is the "Rule of Two"?

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.

Why Sponsors Should Pay Attention

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

Eligibility: Where Strategy Becomes Critical

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

The Industry Reality: Familiar Pain Points, Now Reframed

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.

Bridging the Gap: From Opportunity to Execution

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.

Where ProductLife Group and Commercial Eyes Supports You

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.

From Approval to Access

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

Key Takeaway

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.