EMA launches data sharing pilot to gain confidence in NAMs, reduce animal testing
The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot to allow drug developers to share data generated by new approach methodologies (NAM), which regulators say may help reduce the need for traditional animal studies during drug development. The announcement follows other efforts by global regulators to reduce reliance on animal testing.
"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," said EMA. "NAMs can include complex in vitro systems such as organoids and microphysiological systems, computational models, as well as a combination of multiple methodologies.
"Ultimately, this initiative aims to strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making," the agency added. "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."
EMA noted that NAMs are increasingly being used in research and early drug development, but the data generated from their use typically aren’t shared with regulators. The agency said that the lack of information sharing by NAMs is limiting regulators' opportunities to build confidence in their use in regulatory applications.
"The new VDS pilot aims to create 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," said EMA. "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.
"The initiative aims to enhance scientific dialogue, increase regulatory experience with NAMs, promote harmonised assessment approaches across Europe and support the development of a sustainable framework for integrating these innovative methods into medicines regulation," the agency added.
Stakeholders interested in participating in the pilot can submit an initial application to express their interest, after which EMA said it would review and select applicants to submit a full briefing package for scientific assessment. Interested parties can apply for the pilot through Q3 2027, according to the agency, and eventually, EMA plans to publish a report on the lessons learned from the pilot.
International efforts
EMA's announcement comes after other global regulators have taken similar steps to rely more on NAMs to reduce animal testing. In March, the US Food and Drug Administration (FDA) published a draft guidance to help drug sponsors transition from animal studies to non-animal alternatives in product development using NAMs. (RELATED: Industry says FDA’s guidance on animal testing alternatives needs work, Regulatory Focus 21 May 2026)
Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) also published a guidance in March on how it plans to review clinical trial authorization applications and marketing authorization applications that use non-animal data. The agency said it will work to phase out animal testing as much as possible by helping product developers use NAMs. (RELATED: MHRA moves to reduce animal testing with new guidance, Regulatory Focus 25 March 2026)
On the heels of that announcement, EMA's Committee for Medicinal Products for Human Use (CHMP) issued a draft qualification opinion for NAMs using virtual control groups (VCGs) in dose-range-finding studies, thereby reducing the need for concurrent control groups that use animals. The proposed qualification specifically addresses the use of VCGs in non-clinical rat dose range-finding (DRF) studies, and the agency said their use could reduce the number of control animals or completely replace them in concurrent control groups. (RELATED: EMA proposes new method to reduce animal drug testing, Regulatory Focus 31 March 2026)
More recently, EMA published a blog post on LinkedIn touting its work with global regulators in the International Coalition of Medicines Regulatory Authorities (ICMRA) to reduce regulatory burdens through the Pharmaceutical Quality Knowledge Management System (PQKM) initiative. Among its achievements, the agency highlighted the Collaborative Assessment Pilot, which began in June 2022, that led to the development of a Post-Approval Change Management Protocol that allows manufacturers and regulators to agree on pre-specified changes.
EMA said that one of the changes regulators agreed to was to replace the traditional Limulus Amebocyte Lysate (LAL) test for endotoxins with a recombinant endotoxin test. While the traditional LAL test relies on blood-derived material from horseshoe crabs, the recombinant endotoxin test does not, reducing or removing the need for animal-derived materials.
