The European Medicines Agency (EMA) has opened a public consultation on a new “Reflection paper on non-human primates (NHPs) in safety testing of human medicinal products and opportunities for 3Rs implementation”.

The aim of this Reflection Paper is to provide an overview of the scientific and regulatory considerations for using NHPs in the safety testing of human medicinal products. It reviews current uses, highlights existing flexibility in the application of 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. This reflection paper outlines current opportunities to reduce, refine or replace their use in pharmaceutical development and points to emerging advances that may soon gain broader acceptance. With the rapidly evolving landscape of non-clinical safety testing, further opportunities are expected.

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 you can provide your input until 31 January 2026 on the EMA website: Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation – Scientific guideline | European Medicines Agency (EMA).