Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation - Scientific guideline

This reflection paper aims to provide an overview of the scientific and regulatory considerations for non-human primate use in safety testing of human medicinal products. 

It highlights the existing flexibility within published guidelines to incorporate 3Rs approaches and describes novel alternative approaches which may become available in the future. 

Important examples include:

• Use of rodent species (including transgenics) only to evaluate repeat dose toxicity
• Waiving long-term (6-month) studies to evaluate the safety risk associated with monoclonal antibodies
• Use of alternative assays to predict malformations or embryo-foetal lethality in developmental and reproductive toxicity

Keywords: non-human primates, non-clinical, safety, in vivo, drug regulation,  regulatory science, toxicology, animal testing, weight of evidence approach, 3Rs, NAMs

Current version

Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation

Draft: consultation open Consultation dates: 23/10/2025 to 31/01/2026 Reference Number: EMA/CHMP/55697/2025 Summary:

This reflection paper aims to provide an overview of the scientific and regulatory considerations for non human primate use in safety testing of human medicinal products. It highlights the existing flexibility within published guidelines to incorporate 3Rs approaches and describes novel alternative approaches which may become available in the future.  Notwithstanding the detailed conditions outlined herein, some important examples include; use of rodent species (including transgenics) only to evaluate repeat dose toxicity, the waiving of long-term (6 month) studies to evaluate the safety risk associated with monoclonal antibodies, the use of alternative assays to predict malformations or embryo-foetal lethality in developmental and reproductive toxicity.

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