ICH S6(R1) - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

What it says

S6(R1) addresses the preclinical safety evaluation of biotechnology-derived pharmaceuticals, such as monoclonal antibodies and recombinant proteins. It recommends a case-by-case, science-based approach, with emphasis on selecting a relevant animal species, evaluating immunogenicity, and designing studies that fit the product's biological activity.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A standard toxicology package for small molecules does not always fit a biological product, so design is tailored.
• Species relevance is critical, since the product may not be active in common laboratory animals.
• Immunogenicity in animals does not predict immunogenicity in humans but can affect the interpretation of studies.

What inspectors look for

• Whether species selection was justified.
• Whether study design suits the product.
• Whether immunogenicity findings were addressed.

Related regulations