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EMA Launches Pilot to Share Data on Animal Testing Alternatives
The European Medicines Agency has started a new project about ways to test medicines without using as many animals.
These methods are called New Approach Methodologies, or NAMs.
They can include laboratory-grown tissues, tiny systems that imitate human organs, and computer models.
Organizations can voluntarily share their NAM data with regulators.
They can do this even when they are not applying to sell a medicine.
Experts will review the information and provide advice, but their feedback will not make regulatory decisions.
The project is meant to help regulators understand which alternatives are scientifically useful.
Applications can be submitted until the third quarter of 2027, and the agency will later publish what it learned.
The European Medicines Agency launched a voluntary data submission pilot for New Approach Methodologies.
The pilot will let organizations submit and discuss data independently of a marketing authorization application.
Eligible participants include companies, method developers, contract research organizations and academic laboratories.
Participants will receive individual, non-binding feedback from experts across the European medicines regulatory network.
Applications are expected through the third quarter of 2027, followed by an EMA lessons-learned report.
- Who
- The European Medicines Agency and organizations developing or using New Approach Methodologies, including companies, method developers, contract research organizations and academic laboratories.
- What
- The EMA launched a voluntary data submission pilot to share and assess data from alternatives to traditional animal testing.
- Where
- Within the European medicines regulatory network.
- When
- The initiative was published on September 7, 2026; applications are expected until the third quarter of 2027.
- Why
- To give regulators experience with New Approach Methodologies, support their scientific assessment and help replace or reduce traditional animal studies.
Key facts
- Organizer
- European Medicines Agency (EMA)
- Initiative
- Voluntary data submission pilot
- Methods covered
- New Approach Methodologies, including organoids, microphysiological systems and computational models
- Feedback
- Individual, non-binding and non-decisional feedback from an operational expert group
- Participants
- Companies, method developers, contract research organizations, academic laboratories and other stakeholders
- Application period
- Expected to continue until the third quarter of 2027
- Planned outcome
- An EMA lessons-learned report at the end of the pilot
Sources
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