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EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.
The European Medicines Agency (EMA) is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development, it was revealed in a Sep. 29, 2021 press release.
ITF is a multidisciplinary group that offers a dedicated forum to discuss innovative aspects of development, providing opportunity for early dialogue between regulators and drug developers. Through ITF, EMA will be promoting the three principles of replace, reduce, and refine—commonly referred to as the 3Rs.
The forum will enable discussion of 3R-compliant methods and facilitate their integration into the development and evaluation of human and veterinary medicinal products. Additionally, this action by the regulatory body will aid the development and implementation of New Approach Methodologies (NAMs), which are in line with the legislation from the European Union on the protection of animals used for scientific purposes.
Services from ITF will be available free-of-charge, and any NAMs adhering to the 3Rs principles arising from the forum that can be used to fulfill testing requirements will be eligible for consideration. It is expected that by opening the ITF platform up to discussions about 3Rs-compliant methodologies, alternative methods will be integrated more quickly into the regulatory framework.