- EMA launches a voluntary data submission pilot from Q3 2026 to Q3 2027 to evaluate New Approach Methodologies (NAMs) for replacing animal testing.
- The pilot covers four regulatory applicability areas: biologics, reproductive toxicity, safety pharmacology, and hepatotoxicity.
- Companies and research institutions can voluntarily submit NAM data via EudraLink independent of a marketing authorisation application.
- EMA will publish a lessons-learned report at the end of the pilot to inform future regulation of alternative testing methods.
- The pilot replaces the largely unused safe harbour approach and is grounded in the 3Rs principles (replace, reduce, refine).
Background
The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have the potential to provide information comparable to, or better than, current testing approaches while helping to replace or reduce the use of traditional animal studies in the non-clinical development of medicines.
This pilot is part of EMA's efforts to foster the regulatory acceptance of NAMs by enabling regulators to gain experience with these approaches and assess their scientific value in a regulatory context. NAMs can include complex in vitro systems such as organoids and microphysiological systems, computational models, as well as a combination of multiple methodologies.
Key features of the pilot
The pilot creates a structured, non-binding framework that enables companies, method developers, contract research organisations, academic laboratories and other stakeholders to voluntarily submit and discuss NAM data independently of a marketing authorisation application.
"This initiative aims to strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making. It builds on EMA's longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation."
The four Regulatory Applicability Areas (RAAs) covered by the pilot:
| RAA | Area |
|---|---|
| RAA 1 | Risk assessment of biologics with no pharmacologically relevant species or partial response |
| RAA 2 | Developmental and reproductive toxicity (DART) in accordance with ICH S5(R3) |
| RAA 3 | Safety pharmacology in accordance with ICH S7A |
| RAA 4 | Hepatotoxicity and drug-induced liver injury (DILI) prediction |
Timeline and participation
The pilot was presented to industry stakeholders at a kick-off meeting on 11 December 2025. A stakeholder survey was circulated in January 2026 to prioritise the relevant regulatory applicability areas. The pilot will be officially launched in Q3 2026, with data submissions expected until Q3 2027.
Participation is open to companies, contract research organisations, method developers, non-governmental organisations, academic laboratories and consortia. Interested parties must submit an application form, after which selected applicants are invited to submit a full briefing package via EudraLink.
Feedback and outcomes
Participants will receive individual, non-binding and non-decisional feedback from an operational expert group comprising non-clinical experts from across the European medicines regulatory network.
At the end of the pilot, EMA will publish a "lessons-learned" report summarising the main scientific, regulatory and operational insights gained. The report will contribute to global alignment (e.g. IMRWG-3Rs and ICH) and support the drafting of CoU-based acceptance criteria in EMA's 3Rs guideline.
Regulatory context
The pilot replaces the "safe harbour" approach introduced in EMA's 2012 guideline, which has seen little to no uptake. While industry routinely applies NAMs in early-stage drug discovery and development, data sharing with regulators is typically limited, limiting opportunities to build confidence in their regulatory application.
Relevant documents: