In October 2025 the US Food and Drug Administration handed out nine vouchers promising to review a drug application in one to two months. The conventional figure is ten. Whatever else that pilot turns out to be, it is a useful marker of where the industry now thinks time is recoverable, and of how much of the lab-to-market journey the regulator was never the bottleneck for in the first place.
Key takeaways
- Only 7.9% of drugs entering Phase I between 2011 and 2020 reached approval, on BIO and Informa data.
- Priority Review targets FDA action in six months against ten for a standard review.
- CTIS became the single route into EU trials on 31 January 2025.
- The FDA’s national priority voucher pilot targets one to two months, and is under congressional scrutiny.
The number that frames every acceleration claim
Speed talk in this industry usually skips the attrition rate, which is where most of the calendar actually goes. The reference dataset is the joint analysis published by BIO, Informa Pharma Intelligence and QLS in February 2021, covering 12,728 clinical phase transitions across 9,704 development programmes between 2011 and 2020. Across all modalities, the likelihood of approval measured from Phase I was 7.9%. Conventional small molecule new entities came in at 5.7%; biologics at 9.1%.
Read that alongside any timeline claim and the arithmetic changes. Shaving two months off a review affects one programme in roughly thirteen, at the very end. Moving a failure from Phase III back to Phase II affects the twelve that never make it, and it does so at the point where the spending curve is still climbing. This is why the most consequential acceleration work sits in target selection, biomarker strategy and trial design rather than in regulatory affairs, however much the announcements suggest otherwise.
Four American routes, and what each one actually buys
The four expedited mechanisms are routinely lumped together as “fast-track approval”, which is wrong on both halves. Three of them are designations that change how the FDA interacts with a sponsor. One is an approval pathway that changes the evidence standard itself.
| Mechanism | What it is | What changes |
|---|---|---|
| Fast Track | Designation | More frequent contact with reviewers, and eligibility for rolling submission |
| Breakthrough Therapy | Designation | Everything Fast Track offers, plus intensive guidance on trial design and senior FDA involvement |
| Priority Review | Review clock | FDA aims to act within six months rather than ten |
| Accelerated Approval | Approval pathway | Approval on a surrogate endpoint reasonably likely to predict benefit, with confirmatory trials owed afterwards |
Accelerated approval is the one that has tightened rather than loosened. The Food and Drug Omnibus Reform Act of December 2022 amended section 506(c) of the Federal Food, Drug and Cosmetic Act to let the FDA require a confirmatory trial to be underway at the time of approval, to withdraw an approval through an expedited procedure without the old formal public hearing, and to publish the status of outstanding confirmatory trials. Draft guidance issued in January 2025 signalled that the agency intends to apply the underway requirement as the norm rather than the exception. In practice, a sponsor now buys earlier market access by committing to trial infrastructure sooner, not by deferring it.
Europe rebuilt the machinery instead of the clock
The European route took a different approach over the same period, and it is a structural one. Regulation (EU) 536/2014 replaced the old Clinical Trials Directive, and since 31 January 2025 the Clinical Trials Information System has been the single route for authorising and registering a trial in the Union, with legacy trials obliged to migrate. One dossier, one coordinated assessment across member states, one public register.
Alongside it, good clinical practice was rewritten. The ICH E6(R3) principles and Annex 1 were published on 6 January 2025 and took effect in the EU on 23 July 2025, with Annex 1 built for decentralised elements, electronic data capture and risk-proportionate oversight rather than uniform monitoring. Annex 2, covering less conventional designs, follows on 15 January 2027. None of this shortens a review, and all of it removes friction from the part of the programme that consumes years rather than months.
The 2025 experiment, and why to read it carefully
The FDA’s Commissioner’s National Priority Voucher pilot was announced in June 2025 and issued its first nine vouchers on 16 October 2025, with a further six the following month. The stated target is FDA action within one to two months of a sponsor’s final application submission, using a team-based review rather than sequential handoffs. The vouchers are non-transferable, which is a deliberate break from the priority review voucher market, and they are awarded against declared national priorities: public health crisis response, genuinely innovative treatments, large unmet need, onshoring of development and manufacturing, and affordability.
Treat the outcome as unproven. The programme has drawn congressional scrutiny over how recipients were selected, and a Federal Register public hearing followed in March 2026. A one-month review target is a resourcing commitment, not a scientific one, and whether it survives contact with a complex file at scale is precisely what the pilot exists to find out.
Reading acceleration claims without being misled
Does an expedited designation mean the drug works better? No. Designations describe the seriousness of the condition and the preliminary evidence of advantage over available therapy. They say nothing about the size of the eventual benefit, and a drug can hold two designations and still fail its pivotal trial.
Does approval on a surrogate endpoint mean the benefit is proven? Not yet. That is the explicit trade in accelerated approval: an endpoint reasonably likely to predict clinical benefit is accepted in exchange for confirmatory work afterwards, and the FDA can withdraw the approval or change the labelled indication if that work fails to verify benefit.
Is a shorter development timeline always the goal? It is the goal for the programmes that will succeed. For the roughly nine in ten that will not, the valuable acceleration is the one that reaches the negative answer sooner and cheaper, which is why adaptive designs and interim futility analyses matter more to a portfolio than to any single asset.
The pattern across all three regions is consistent. Where regulators have moved, they have mostly moved procedure: fewer parallel submissions, earlier conversations, oversight scaled to risk. The scientific bottleneck, which is knowing early whether a molecule does what the biology suggested it would, has not moved much at all, and no voucher will shift it. Anyone tracking how this plays out across the wider sector will find the same tension in our look at pharmaceutical innovations that could save lives this decade.
Wondering what happens after approval?
Getting a medicine authorised is one problem. Proving where every batch has been is a different one entirely.
Read our assessment of blockchain in the pharmaceutical supply chain
Sources: BIO, Informa Pharma Intelligence and QLS Advisors, “Clinical Development Success Rates and Contributing Factors 2011-2020”, published February 2021, covering 12,728 phase transitions across 9,704 programmes, likelihood of approval from Phase I of 7.9% for all modalities, 5.7% for small molecule new entities and 9.1% for biologics; US Food and Drug Administration pages on Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review, including the six-month Priority Review goal against ten months for standard review; Food and Drug Omnibus Reform Act of 2022, amending section 506(c) of the Federal Food, Drug and Cosmetic Act, and FDA draft guidance of January 2025 on confirmatory trials being underway; FDA announcements of the Commissioner’s National Priority Voucher pilot (June 2025), the first nine vouchers (16 October 2025) and a second batch (November 2025), together with the Federal Register notice of a public hearing on the pilot (March 2026); Regulation (EU) 536/2014 and European Medicines Agency guidance on the Clinical Trials Information System becoming the sole route from 31 January 2025; ICH E6(R3) Good Clinical Practice, principles and Annex 1 published 6 January 2025 and effective in the EU from 23 July 2025, Annex 2 effective 15 January 2027. Success rates are historical averages across a decade of programmes and are not predictive for any individual asset. Nothing here is regulatory, investment or medical advice. Updated August 2026.
