On 1 September 2026 EMA launched a voluntary data submission pilot for New Approach Methodologies — the organ-on-chip systems, human tissue models, organoids and computational toxicology tools that aim to replace or reduce animal studies in non-clinical development. The unusual feature is the timing: you can submit the data without having an application on the table.
What the pilot actually offers
The pilot creates a structured, non-binding route for submitting NAM data to EMA independently of any marketing authorisation application. Participants receive non-binding feedback from an expert group drawn from non-clinical specialists across the European regulatory network.
It is open beyond the usual applicant population. Companies, method developers, contract research organisations, academic laboratories and other stakeholders can take part — which matters, because the organisations generating the most interesting NAM data are often not the ones holding the marketing authorisations.
Why regulators are doing this
The obstacle to regulatory acceptance of non-animal methods has never been mainly scientific enthusiasm. It has been experience. An assessor asked to accept a microphysiological system in place of an established animal model needs a basis for judging its reliability, and that basis comes from having seen the method applied repeatedly across contexts.
EMA frames NAMs as having the potential to provide information comparable to, or better than, current approaches. The pilot is a mechanism for regulators to build familiarity before the methods arrive inside a dossier where a decision has to be made under time pressure.
What counts as a NAM
- complex in vitro systems, including organoids and microphysiological systems
- human tissue-based models
- computational models, including computational toxicology
- combinations of several methodologies used together
Who should consider taking part
The feedback is non-binding, so this is not a route to a regulatory commitment. It is useful where the value lies in de-risking rather than in securing a position:
- Developers planning to rely on a NAM in a future application, who would rather discover an assessor’s reservations years before submission than during it.
- Method developers and CROs seeking regulatory-grade feedback on qualification strategy while a method is still being refined.
- Academic groups whose work may never enter a dossier directly but whose data contributes to the evidence base a method needs.
- Companies with 3Rs commitments who need a defensible account of how they are pursuing replacement and reduction in practice.
The practical caution
Voluntary engagement of this kind still costs internal effort and exposes preliminary data to regulatory eyes. Decide in advance what you are prepared to share, make sure the submission is scientifically finished enough to earn useful feedback rather than generic caution, and be clear internally that non-binding means exactly that — favourable feedback in the pilot does not commit an assessor evaluating your dossier later.
It is also worth watching the international picture. Regulatory appetite for non-animal methods is not moving at the same speed or in the same direction on both sides of the Atlantic, and a development programme intended for both markets needs a non-clinical strategy that survives either outcome.
How PQRA helps
We advise on non-clinical strategy and its regulatory acceptability, prepare submissions and briefing packages for voluntary and formal regulatory interactions, and help developers judge where an emerging methodology genuinely strengthens a dossier and where it adds risk.
If you are weighing a NAM-based approach in your development programme, get in touch with our regulatory team.
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