Taking the leap toward human-specific nonanimal methodologies: The need for harmonizing global policies for microphysiological systems

In March 2023, the Indian Government passed an Amendment to the New Drugs and Clinical Trials (2023)(1) whereby several non-animal new approach methodologies (NAMs), including cell-based assays, microphysiological systems (MPS), computational modelling, and other human biology-based test methods are now included in the list of nonclinical testing methods to assess the safety and efficacy of a new drug along with animal studies. MPS is an umbrella term that has been used for miniature human cell based in vitro constructs, including, organoids, 3D tissues, and organ-on-chip (OoC) that aim to mimic human physiology. In the recent decade, several countries, including the US, the EU, Canada, Brazil, South Korea, and Japan have made legislative strides towards non-animal methodologies. While in many countries, including India, the development of these methods is still in its infancy, removal of this legislative barrier provides incentives and confidence to the industry to accelerate the development and incorporation of these methods in their internal portfolio for decision making or through dynamic industry-academia partnerships.

PARVATAM Surat;  PAMIES David;  PISTOLLATO Francesca;  BEKEN Sonja;  MARIAPPAN Indumathi;  ROTH Adrian;  PIERGIOVANNI Monica;  MAISONNEUVE Benoit;  EWART Lorna C.;  MAJUMDER Abhijit;  DANDEKAR Prajakta;  DATE Rahul;  MAHADIK Kasturi;  THIYAGARAJAN Saravanan;  COECKE Sandra; 

2024-01-11

CELL PRESS

JRC134698

2213-6711 (online),   

https://www.cell.com/stem-cell-reports/fulltext/S2213-671100457-5,    https://www.sciencedirect.com/science/article/pii/S2213671123004575,    https://publications.jrc.ec.europa.eu/repository/handle/JRC134698,   

10.1016/j.stemcr.2023.11.008 (online),