EMA’s revised reflection paper offers ‘snapshot’ of animal testing alternatives
The European Medicines Agency (EMA) has released a revised draft reflection paper that outlines non-animal replacement tests manufacturers can use to eliminate the use of animals in pharmaceutical testing.The paper aligns with international efforts to replace, reduce and refine the use of animals in research used to support the marketing authorization of drugs, referred to as the “3Rs,” and will replace an earlier version that was adopted in 2018. (RELATED: EMA Highlights Efforts to Reduce and Refine Animal Testing for Drugs, Biologics, Regulatory Focus 26 February 2018)
EMA said the paper “should encourage sponsors to develop new 3Rs methodologies and submit them for regulatory review and acceptance.”
The paper also complements the December 2016 “Guideline on the Principles of Regulatory Acceptance of 3Rs (replacement, reduction, refinement) Testing Approaches,” serving as a follow-up to that guideline.
The paper provides an overview of the regulatory requirements for animal testing across various working parties. This includes the Committee for Medicinal Products for Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP), and the European Pharmacopoeia. Additionally, it discusses the requirements of CHMP's non-clinical working party, biosimilar medicinal working party, biologics working party, vaccines working party, and the Committee for Advanced Therapies (CAT).
The information is organized in a table and categorized by the responsibilities of the EMA working parties responsible for approving the testing.
For example, the CHMP/CVMP Quality Working Party and European Pharmacopoeia have established alternatives to using horseshoe crab blood for testing endotoxins in parenteral products, with the Recombinant factor C (rFC) method being a key alternative.
The working party has also endorsed the use of the monocyte activation test (MAT) as a replacement for the rabbit pyrogen test to test for pyrogens in new parenteral drugs.
Also, animal tests using rats or mice have been eliminated for certain physiological distribution studies for radiopharmaceutical preparations.
The deadline for commenting is 30 June 2025.
Reflection paper
