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The EMA has launched a pilot allowing stakeholders to voluntarily submit data regarding new approach methodologies (NAMs) designed to replace and reduce animal testing.
This initiative supports the regulatory acceptance and implementation of innovative testing methods that could lead to a decrease in animal testing, aligning with the 3Rs principle (Replacement, Reduction, Refinement) in research.
Stakeholders must express interest in the pilot by submitting an application form prior to the full submission of data, with the pilot set to run through 2027.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Stakeholders must express interest in the pilot by submitting an application form prior to the full submission of data, with the pilot set to run through 2027.
The EMA's new pilot facilitates the submission of data derived from innovative testing methods aimed at replacing, reducing, and refining traditional animal testing during non-clinical medicine development. This program encourages contributions from various stakeholders independent of the standard marketing authorization applications.
What changed: The EMA has launched a pilot allowing stakeholders to voluntarily submit data regarding new approach methodologies (NAMs) designed to replace and reduce animal testing.
Why it matters: This initiative supports the regulatory acceptance and implementation of innovative testing methods that could lead to a decrease in animal testing, aligning with the 3Rs principle (Replacement, Reduction, Refinement) in research.
Practical implication: Stakeholders must express interest in the pilot by submitting an application form prior to the full submission of data, with the pilot set to run through 2027.
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