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Regulatory Modernizations
Covers change in the global regulatory landscape relative to non-animal methods such as human-based in vitro methods
FDA releases draft guidance on alternatives to animal testing in drug development
18 Mars 2026 The purpose of FDA's draft guidance is to provide drug developers with a validation framework of alternatives to animal testing for nonclinical safety, here referred to as new approach methologies (NAM), such as in vitro and in silico methods. The document emphasises that a NAM does not need to be formally validated before FDA’s drug review centres (primarily the Center for Drug Evaluation and Research) can evaluate it as part of a drug development programme. In
European Commission publishes its roadmap towards phasing out animal testing
© Sania Ristic 2026 — Licensed under CC BY‑NC‑ND 4.0 01 June 2026 In response to the 2023 European citizens’ initiative (ECI) ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing,’ the European Commission (EC) has published its 'Roadmap towards phasing out animal testing for chemical safety assessments'. This response arrives against the backdrop of more than 15 million animals being used in animal experiments between 2015-2023 by companies to prove that
MHRA announces new regulatory action to support the phase‑out of animal testing
25 Mars 2026 The UK's Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring that medicines and healthcare products available in the UK are safe and effective, has announced new regulatory guidance in support of the government policy to phase out animal testing. This guidance applies to the MHRA’s approach to its review of Clinical Trial Authorisation applications and of Marketing Authorisation applications for medicinal products. The MHRA star
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