On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and veterinary medicines. The EMA is promoting these principles, commonly referred to as the 3Rs, through the Agency’s Innovation Task Force (ITF). In its announcement, the Agency notes that “this action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes.”
EMA’s Innovation Task Force is “a multidisciplinary group that includes scientific, regulatory, and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development.”
One objective of the group is to encourage and establish communication between regulators and Sponsors early to identify and discuss scientific, legal, and regulatory issues related to emerging therapies technologies. This early communication is accomplished through the conduct of ITF briefing meetings with eligible Sponsors.
Ensure awareness and preparedness within EMA for the assessment of the most recent development in innovative medicines
As such, “it will provide an opportunity to discuss 3R-compliant methods and facilitate their integration into the development and evaluation of medicinal products.”
Alternative approaches to animal models “provide opportunities to develop better and more predictive scientific tools to protect human and animal health as well as the environment.” Some of these alternative approaches include improved tests based on human and animal cells, organoids, organ-on-chips, and in silico modeling.
By opening the ITF platform to discussions of methodologies that are compliant with the 3Rs, EMA hopes to encourage drug developers to prioritize and expedite the integration of alternative methods into the regulatory framework. Furthermore, this action is in line with EMA’s Regulatory Science Strategy to 2025, which is intended to build a more adaptive regulatory system and encourage innovation in product development.
Interested drug developers are encouraged to engage ITF to ask questions and apply a briefing meeting to discuss NAM and treatments intended to tackle antimicrobial resistance (AMR). In its announcement, EMA also notes that ITF’s services are free of charge and any NAMs adhering to the 3Rs principles that can be used to fulfil testing requirements are eligible for consideration.
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