What is the Origin of Marketing Authorisation Application (MAA)?

This regulatory term is specific to the European Union's centralized or decentralized drug approval processes, paralleling the New Drug Application (NDA) process in the United States. The MAA system was established to standardize and harmonize drug approval across member states, facilitating market access.

What is the Mechanism of Marketing Authorisation Application (MAA)?

The MAA review mechanism involves a thorough, multidisciplinary assessment of the submitted dossier by scientific experts. The evaluation focuses on whether the clinical benefits of the drug outweigh the risks, based on the evidence of its quality and efficacy demonstrated in controlled studies. Successful authorization permits the company to begin commercial distribution, subject to ongoing pharmacovigilance requirements for post-market safety monitoring and risk management.

Marketing Authorisation Application (MAA)

Meaning

Marketing Authorisation Application (MAA) is a formal, comprehensive submission made by a pharmaceutical company to a European regulatory body, such as the European Medicines Agency (EMA), seeking permission to commercially market a new medicinal product within the European Union. This application aggregates all preclinical, chemical, manufacturing, and clinical trial data to demonstrate the drug’s quality, safety, and efficacy. It is the final administrative step before a drug can be legally sold to the public across member states.