The European Medicines Agency (EMA) has launched a public consultation on a draft “Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation”.
The reflection paper provides an overview of the scientific and regulatory considerations for using non‑human primates (NHPs) in the safety testing of human medicinal products. It reviews current uses, highlights existing flexibility in applying the 3Rs principles (Replacement, Reduction and Refinement), and points to emerging alternatives that could further reduce or replace NHP use in the future.
NHPs should be used for regulatory safety testing only as a last resort. The document outlines current opportunities to reduce, refine or replace their use in pharmaceutical development and describes scientific advances that may soon gain broader regulatory acceptance.
Progress in novel, including non‑animal, approaches is scientifically and ethically essential and will depend on continued innovation, collaboration and proactive regulatory engagement.
The draft document is open for consultation, and stakeholders can provide input until 31 January 2026 via the EMA website: Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation – scientific guideline.
