The European Medicines Agency’s innovation network says regulatory changes are needed to give clarity to sponsors on when they can use alternatives to animal testing, known as new approach methodologies (NAMs).
NAMs intended for regulatory use in medicine development are currently advancing to technology readiness levels sufficient for initial engagement with regulatory authorities and inclusion in weight-of-evidence regulatory submissions and/or in specific contexts of use.
In a horizon scanning report, the innovation network said that large pharmaceutical companies are less likely to share data on NAMs with regulators than SMEs and academia.
Regulators must adopt strategies that encourage developers to share data on NAMS, for instance by better communicating existing ways that companies can seek advice on the use of NAMs.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

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