The European Medicines Agency (EMA) has released a Concept paper for public consultation, focusing on revising guidelines related to the regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches. The initial guideline, adopted nearly seven years ago, aimed to encourage stakeholders and authorities to adopt and support the development of 3Rs testing approaches, intending to replace, reduce, and refine in vivo animal studies for both human and veterinary medicinal products.
Over the years, advancements in scientific, technological, and regulatory knowledge, particularly in microphysiological systems (MPS) and organ-on-chip models (OoC), have necessitated a more detailed approach. The EMA recognizes the evolving landscape and the need for specific guidance to define regulatory acceptance criteria for models like MPS and OoC within the pharmaceutical domain. This guidance, to be annexed to the revised guideline, aims to facilitate the development and potential regulatory use of New Approach Methodologies (NAMs), offering flexibility for future updates based on scientific and technological progress.
Additionally, there is a call to define crucial 3Rs-related terms, forming the foundation for EMA documents in the realm of NAMs. This aspect will be elaborated upon in a dedicated section within the guideline. Stakeholders are invited to provide comments on these proposed revisions by February 28, 2024, utilizing the EU survey provided for this purpose.
Click here to access the survey and provide comments.
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