EMA announces new efforts to minimize animal testing
The European Medicines Agency (EMA) has announced it will be providing “special support” to help drug developers use alternative approaches to animal testing through its Innovation Task Force (ITF). Such approaches include tests based on human and animal cells, organoids, organ-on-chips and insilico modeling, all of which have promise to be more predictive scientific tools.The task force, established by EMA in 2014, is a horizontal cross-sectorial group that brings together experts in the quality, safety, efficacy and pharmacovigilance areas and serves to facilitate early dialogue with sponsors on scientific, legal and regulatory issues of emerging therapies and technologies.
Through these meetings, which are free of change, the task force will promote the use of these alternate approaches, collectively known as new approach methodologies (NAMs).
EMA said this move is meant to facilitate the implementation of NAMs, to make progress toward the ultimate goal of the EU’s 2010 legislation, which eventually aims to fully replace animal models used for scientific purposes.
An EMA working group addresses how animals are used in regulatory testing, using the “3Rs” framework of replacing and reducing animal testing when possible, along with refining testing practices to reduce stress on animals and enhance animal welfare. “Opening the ITF platform to discussions of 3Rs-compliant methodologies is expected to encourage prioritising and speeding up the integration of alternative methods into the regulatory framework,” wrote EMA in a Wednesday announcement of the special supports for developers.
Sponsors may apply for a meeting with the task force at: [email protected]/. EMA will advise applicants on how to proceed.
The announcement aligns with EMA’s regulatory science strategy to 2025 to build a regulatory system that encourages innovation. One of these strategy goals is to replace and reduce animal testing. (RELATED: EMA Consults on Regulatory Science Strategy to 2025, Regulatory Focus, 19 December 2018).
EMA announcement
