Global Perspective
Guidance, regulatory initiatives and the evolving role of NAMs in drug development.
A new FDA draft describes how in vitro potency and safety data, anchored to clinical evidence, could support variants of individualized genome-editing therapeutics within a defined product boundary.
Australia’s TGA already considers non-animal evidence in therapeutic-goods assessment. Its October 2026 statement ties acceptance of a NAM to its intended use, human biological relevance, technical performance and reliability, with validation evidence scaled to the consequences of a wrong conclusion.
A 1 October joint statement from medicines regulators urges validated non-animal methods across the human-medicine lifecycle, with particular emphasis on batch-release testing. Implementation remains with national and regional authorities.
China’s Center for Drug Evaluation has opened a voluntary NAMs pilot with separate routes for drug-specific regulatory evidence and method validation. Each application must define one context of use and provide evidence suited to the proposed decision.
EMA’s pilot allows developers to discuss nonclinical NAMs data separately from a marketing authorization application. Participants receive individual, nonbinding feedback, and EMA expects to accept submissions through the third quarter of 2027.
The CDE draft combines target biology, in vitro studies, computational models and clinical experience in a weight-of-evidence approach, with product-specific conditions for shorter toxicity studies or replacement of selected animal studies.
FDA’s draft guidance describes four considerations for validating NAMs: context of use, human biological relevance, technical characterization and fitness for purpose. The emphasis is on the decisions that nonclinical data will support.
OECD's IL-2 Luc and IL-2 Luc LTT assays examine T-cell activation-related signaling and antimitotic effects in the same human reporter cell line. The guideline's evaluation includes medicines, but its overall performance figures combine drugs and other chemicals.
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