The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications.
The pressure to replace animal testing with human-relevant assays that are more predictive of human-drug responses has now reached a tipping point, and there is a movement toward greater acceptance of these potentially more translatable tests.
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
