Access Consortium Promise Pilot Pathway: what it is, what changed, and when to consider it
When you are planning filings in more than one jurisdiction, “priority review” is one of those topics that sounds simple until you get into the detail. The Access Consortium’s Promise Pilot Pathway is worth revisiting because it aims to make one part of that process a bit more joined up across the Access agencies.
A quick recap: who is in the Access Consortium?
The Access Consortium is a collaboration between five regulators: Australia (TGA), Canada (Health Canada), Singapore (HSA), Switzerland (Swissmedic) and the UK (MHRA).
They have several work‑sharing initiatives. For new active substances, the key one is the New Active Substance Work‑sharing Initiative (NASWSI).
NASWSI is the wider framework. It describes how agencies can share the assessment work (for example, dividing review across CTD modules), while each agency still runs its own national steps and makes its own national decision.
So what is the Promise Pilot Pathway?
The Promise Pilot Pathway sits within NASWSI. It is focused on priority review.
In plain terms, it is a pilot approach where the Access agencies:
- align the timing for a priority review request; and
- evaluate that priority request in a collaborative way, aiming to reach a consensus view on whether priority status should be granted.
What Promise is not: it is not a new legal route to approval. It does not replace national processes, and it does not remove national decisions.
Why are people talking about it again?
The Promise Pilot Pathway was first announced in December 2023.
The NASWSI operational procedures were updated to include the pathway, and then updated again (including an update dated June 2025).
The government UK page has also been refreshed since the original publication.
So, it is not “brand new”. But it is something sponsors and RA teams are looking at again when they are planning multi‑jurisdiction strategy and want to understand what is realistically possible on timing.
Eligibility: who is it aimed at?
The eligibility criteria are narrow and specific. The public regulator summaries and the NASWSI operational procedures describe the pathway as being for new active substances (and the procedures also reference new indications) that:
- diagnose, treat or prevent a condition that is serious, life‑threatening or severely debilitating; and
- where no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication.
If a programme does not fit that framing, the Promise Pilot Pathway is unlikely to be the right direction.
How the Promise Pathway process works – a high level view
The NASWSI operational procedures describe the pathway as starting early, via an Expression of Interest (EoI).
EoI timing
For the Promise Pilot Pathway, the guidance is to submit an EoI at least 6 months* before filing.
The procedures also recognise that you might not know until closer to filing whether priority is realistic, and they encourage discussion with the proposed agencies about timelines and whether you need to keep options open.
*As a comparison, non-Promise Pilot Pathway EoI submission timings are “at least 3 months” prior to filing.
Eligibility confirmation and lead agency
After the EoI, the participating agencies consider whether the eligibility criteria are met. If they are, they confirm this and a lead agency is determined.
One shared package for the priority request
For eligible EoIs, applicants submit one scientific data package and justification so the Access Consortium agencies can assess whether the evidence supports granting priority review. One agency leads and the others peer review, with the aim of reaching a consensus view on priority status.
What happens if the agencies do not align?
The procedures set out what happens if consensus is not reached. In short, you may still be able to proceed under the Promise Pilot Pathway with the agencies that accepted the request, and use the standard Access procedure for other agencies.
The procedures also state that if priority review status is not granted, you cannot use the Promise Pilot Pathway (although you may still have national options, depending on the jurisdiction).
Practical points that matter in planning
This is the part that usually matters most to sponsors.
- Timing is not an afterthought
The pathway is built around early engagement (the 6‑month EoI expectation). If you are already close to filing, it becomes harder to use the process as intended. - Keep the “work‑sharing” context in mind
The pathway focuses on the priority request, but it sits within NASWSI. NASWSI expects a coordinated approach across jurisdictions, including consistency in the Modules 2–5 dataset (with differences documented if needed). - Be ready for a different rhythm under priority review
NASWSI describes that, for the priority review pathway, agencies may issue rolling questions through the evaluation period, with defined response timelines. That has a real impact on resourcing. - National decisions still apply
The pathway is about alignment and efficiency. It is not a single combined approval and it does not remove national requirements.
Useful tip
If you think priority might be relevant, start the internal conversation early. Even if you later decide not to proceed with the Promise Pilot Pathway, the EoI timeline forces helpful discipline into your plan.
How Fusion Pharma can help
If you are considering whether the Access Consortium Promise Pilot Pathway could be suitable for your programme, we can help you sense‑check your product against the eligibility criteria, map the EoI timing into your submission plan, and work through what this means for your overall strategy across Access markets.
Need to talk it through?
Message Fusion Pharma on LinkedIn, or through our Contact page.
FAQs
- Is “Promise” an acronym? Should it be PROMISE?
The regulator pages and the NASWSI operational procedures style it as “Promise” (capital P), not all caps. - Is Promise a new approval route?
No. It is a pilot approach for aligning how priority review status is requested and assessed across Access agencies. National processes still apply and each agency still makes its own national decision. - What are the eligibility criteria, in one sentence?
It is intended for new active substances (and the procedures also reference new indications) for serious conditions where no other treatment is registered and marketed in participating jurisdictions for the proposed indication. - When should a sponsor start engaging?
The NASWSI operational procedures advise an Expression of Interest at least 6 months before filing for the Promise Pilot Pathway. - What if the Access agencies do not agree on priority status?
The procedures describe options including proceeding via the Promise Pilot Pathway with agencies that accepted the request and using the standard Access procedure for other requested agencies. - If priority status is not granted, can a sponsor still use the Promise Pilot Pathway?
The procedures state that if priority status is not granted, an applicant cannot use the Promise Pilot pathway (though national priority/fast‑track requests may still be possible where applicable). - Does the Promise Pilot Pathway remove national requirements like Module 1?
No. NASWSI is explicit that Module 1 remains jurisdiction‑specific and that each agency makes its own sovereign decision.
If you would like to discuss how Fusion Pharma can support you with Variations, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
