AbangeLabsThe UK just made non-animal evidence planning more real: MHRA’s new advance Module 4 review route gives teams an earlier read on whether their package will hold up. https://www.mattheneus.com/editorial/mhra-non-animal-methods-module-4-advance-review-guidance-2026-04-02 #HTA #RegulatoryAffairs #Pharma
Medicines and Healthcare products Regulatory Agency (MHRA) opens an advance Module 4 review route for medicines developed without animal studies
Medicines and Healthcare products Regulatory Agency (MHRA) now offers a clearer regulatory route for medicines developed without animal studies, including an advance Module 4 review mechanism by end-2026 and sharper expectations for how teams justify safety, mechanism, and evidence use in health technology assessment (HTA) and regulatory planning.