New Regulation to Reduce Animal Testing to be Implemented in Europe

The European Medicines Agency (EMA) is offering new funding to help researchers replace, minimize, and refine the use of animals in drug development and testing. 

Through the EMA’s Innovation Task Force (ITF), the agency is advocating these three principles – replace, reduce, and refine; also known as the 3Rs. According to the EMA, this move will make it easier to develop and deploy New Approach Methodologies (NAMs) that are compliant with EU legislation on the protection of laboratory animals. 

ITF is a dedicated venue for early interaction between regulators and drug developers to address novel features including developing therapies, methodologies, and technologies. The ITF is a multidisciplinary group with scientific, regulatory, and legal expertise that was established to ensure EMA cohesion. It will be an opportunity to talk about 3R-compliant methodologies and how to incorporate them into the development and evaluation of pharmaceuticals. According to the EMA, any NAMs complying with the 3Rs principles that can be used to meet testing requirements will be eligible for consideration during the forum. 

The European Medicines Agency (EMA) will investigate a variety of alternatives to animal models, including better tests using human and animal cells, organoids, organ-on-chips, and in silico modeling. These approaches, according to the EMA, also allow for the development of better and more predictive scientific instruments to protect human and animal health, as well as the environment. 

By allowing debates of 3Rs-compliant procedures on the ITF platform, it is hoped that alternative approaches will be prioritized and integrated into the regulatory framework more quickly. This move is in accordance with the European Medicines Agency’s Regulatory Science Strategy to 2025, which aims to create a more adaptable regulatory environment that encourages innovation in human and veterinary medicine.