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NC3Rs | 20 Years: Pioneering Better Science

Human Tissue for Safety Pharmacology Regulator Q&A: Human tissue-based models in medicine development

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The aim of this Q&A document is to provide clarification on the views of the agencies involved in the regulatory acceptance of the use of human tissue models in support of medicines development. This document has been prepared following an NC3Rs workshop and in collaboration with members of the NC3Rs/MHRA Human Tissue in Safety Assessment working group. Endorsement of the document by the individuals listed is not an indication that the agency they are working for has ratified this document, despite that the respective agencies support the principles of 3Rs in general.


Authors: M Beharry MHRA, Sonja Beken FAMHP, Susanne Brendler Schwaab BfArM, A Holmes NC3Rs, S Jackson NC3Rs, D Jones MHRA, Tiina Palomaki Fimea. In association with the NC3Rs Working Group on Human Tissue in Safety Pharmacology

Human Tissue for Safety Pharmacology Regulator Q&A


  1. Megit, S (2011). Immunocore pioneers new safety studiesMedNous, 5(4), 14-15