The FDA launched the “New Alternative Methods” program in 2023 to qualify human-relevant in vitro assays (e.g. organoids, organs-on-chips) for safety testing and to give clear guidance on their use in place of animal data.
The EMA published a concept paper in 2024 that proposes updating EMA guidelines to include specific regulatory acceptance criteria for microphysiological systems (MPS) and organ-on-chip models
In 2025, the WHO drafted guidelines that promote removing animal tests that are unfit or redundant and replacing in vivo adventitious-agent/HA/HAI assays with molecular methods like PCR and high-throughput sequencing.