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NMPA Immunogenicity Guidance

Meaning

NMPA Immunogenicity Guidance refers to the official regulatory guidelines and technical requirements issued by the National Medical Products Administration (NMPA) of China regarding the assessment and management of immunogenicity for biological therapeutic products, including recombinant hormones and growth factors. These guidelines dictate the specific study designs, assay methodologies, and data interpretation standards that pharmaceutical companies must follow when evaluating the potential for their drug to elicit an anti-drug antibody (ADA) response in patients. Adherence to this guidance is mandatory for the clinical trial application and eventual market approval of biologics within the Chinese jurisdiction. This regulatory framework ensures patient safety and consistent product quality.