Biologicals: finished product

The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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Pharmaceutical development

Guidelines

Product information

Guidelines


Points to consider for assessors


Concept papers


Adventitious agents safety evaluation

Guidelines


Position papers and statements


Transmissible spongiform encephalopathies (TSEs) (animal and human)

Guidelines


Questions and answers


Position papers, public statements and reports


Investigational medicinal products

Guidelines


Genetically modified organisms (GMOs)

Guidelines


Specifications

Guidelines


Lifecycle management

Guidelines

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