EMA has analyzed its data over the last 15 years in implementing the 3Rs and now in the context of NAM what has occured with new regulations and international harmonization efforts.
The articles Abstract: "Driven by scientific advancements, the replacement, reduction and refinement of animal use (i.e. the3Rs principles) in research and testing are gaining momentum. There is increasing interest in the use ofinnovative testing methods, known as 'New Approach Methodologies' (NAMs), in the regulatory testingof medicines. Such approaches can lead to reduced reliance on animal studies while improving clinicaltranslation and predictivity.Since 2010, the European Medicines Agency (EMA) has advanced the implementation of 3Rs principlesin medicines testing through a series of dedicated working groups, culminating in the current 3Rs workingparty (3RsWP). Key pillars of this work include maintaining up-to-date scientific guidance, engaging withstakeholders and advancing international harmonisation. A key focus in recent years has been fosteringregulatory acceptance of NAMs, which has already led to tangible changes. These include thedevelopment of stronger scientific guidance, the increased use of existing EMA platforms for earlydialogue to promote the regulatory uptake of innovative NAMs, and the establishment of the InternationalMedicines Regulators Working Group on 3Rs (IMRWG3R) to ensure international alignment andharmonisation.This article reviews 15 years of EMA's activities in 3Rs, highlighting the achievements of the 3RsWP andoutlining planned future actions and priorities, as it continues to support implementation of the 3Rs inregulatory medicines testing."
#EMA #NAM #3Rs
The article is open source but only pre-print at this time but can be found here: https://pdf.sciencedirectassets.com/788377/AIP/1-s2.0-S3050620426000114/main.pdf?X-Amz-Security-Token=IQoJb3JpZ2luX2VjEBsaCXVzLWVhc3QtMSJHMEUCIARq2zyD6V%2BUn3DF%2BKUXVd9dNcYHhb6dp8yDQiwBSvx5AiEAwhKr5wjOMdq7r0RjO5xT4rM8vUoHv1sERn9bK3cHtpoquwUI4%2F%2F%2F%2F%2F%2F%2F%2F%2F%2F%2FARAFGgwwNTkwMDM1NDY4NjUiDCbhvaT7bVlCeUzewSqPBS4jOjy6joDDHu9MItUOMrwX%2BHuHZLrUWu%2BnyqBTTgG1HF%2FNhRpFSWNp4T8CnxC6%2BFB92wg8dlN2cnul%2F3jZsW76IWxNWsifuQo%2BuDlRl0a28oERFjNHKXP%2FpKwPfZP2rBCOSt6NF%2Fyxdpzi35uF078aWK%2FUqX46hPFezaSR2N5hbz0eT5ia67sxwMOE1%2BveXXH5VA%2BeAoYV62i7LhYxL83aq9cz8sOd0b0DCDuEjapRIgnC6uIjFTFD%2FjJEkWjGsSzGP8I5sT1YPVZougOs7ryM9jIwBSCibVczRXGznE%2BcLqGNXtPNctDd%2FBmqU9bgp7DYGqCFvShPW4a2PO3T5%2BtgFHG1jrsjjgZGa8CGXjaDyfyTh4zctx8Qwl5%2BG8tFVWIa3NKGOnQ1PcDKT1XbC5dB2WmCjPOvYexnppdYBg%2FLnlWGWDwKRUq8jEyhGUBHOqQ0oMz8YnbC7kRVzVO%2B%2FJ5DSYFxb3ZK5KF2e%2FAd%2FccGCMx22EHHwgAOTVSz9TG%2FLk7HWghZwTMmeoRVs1gYnd%2BhdHpcbdVZGjuu8psbE7i7aEEQV2DoaSnb%2FJa8OvCj1W2y2gGeuh%2B%2B7IdRII3s3MnJu8akSI4vMADOgeuvDOXh1ru3Hu39AuqIQ%2F7slg7ZS4ctnrzYVjcTSsN5sqvSOLbkmqH11ZP20Ud6M6mRtxiTzUCi6TZvCvBfjgBWxq6TyX5C9wIKSl8h0Ml5s%2FV%2B6pgeKix%2Bh0V7W0e72XI375fnitXU68YqF65cagHbSWZoNVWUMn0tobErf5Ks9pk3w9OTjsyDfCl9jrgOT5AiHvrSR8ICSe4a1V301HtmUjps1bYYGzPM42HNhYCk1X7Fi0HvhMWzGVZqKSxb%2FjIu2pIwsI2bzgY6sQH%2Fi1b1H%2F0Dyf2mNSk05oDG%2FyVgvlowxlK%2F%2BdkSM5uJZUjZiG%2Bus7%2B0HDh1N8%2BM3nelcrkdh0XhS3TI%2Bz2Ue%2FSFmlytCU8E%2BsNxZy2Q0MDOXwrhtR07TUbGDvjmzPCWk6DzpPYGwwGD7LZsNmCx%2FR%2FfRmLE04zAazeRQJdVlM1n5GlPSdsa25z284a9zjWhj0LgIVMjb%2B8hd%2BfJKHc%2Fdix4wxlrUvB4KNTvZCYHU5yTTe0%3D&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Date=20260327T192837Z&X-Amz-SignedHeaders=host&X-Amz-Expires=300&X-Amz-Credential=ASIAQ3PHCVTYSPBX75L2%2F20260327%2Fus-east-1%2Fs3%2Faws4_request&X-Amz-Signature=1e77bc65e49886f9d0d567ed21bf6b5f2eeb8bbcd4d89dc123467d95ad82f3ff&hash=fa86288d03304fa5b3efbad12ff138697893e6adaf10bc87111767f922d07b8f&host=68042c943591013ac2b2430a89b270f6af2c76d8dfd086a07176afe7c76c2c61&pii=S3050620426000114&tid=spdf-4ac76777-db0f-44e6-9ef4-d347ccaec7ba&sid=8be962a22dc6f546a219127-6f60c89c74ddgxrqa&type=client&tsoh=d3d3LnNjaWVuY2VkaXJlY3QuY29t&rh=d3d3LnNjaWVuY2VkaXJlY3QuY29t&ua=0f15560b555f04005a5756&rr=9e30cc989931c4d1&cc=us