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Marketing Authorization Application (MAA)

Meaning

A Marketing Authorization Application, or MAA, is a formal, comprehensive dossier submitted by a pharmaceutical company to a regulatory authority, such as the European Medicines Agency, or EMA, or the UK’s MHRA, to seek permission to commercially market a new medicinal product. This application serves as the final, critical step in the drug development process, requesting official authorization to distribute the drug across a defined geographic region. The MAA must provide exhaustive evidence demonstrating that the therapeutic benefits of the product outweigh its known risks, that it is safe, and that its quality and manufacturing controls are robust.