A Marketing Authorisation Application (MAA) is the regulatory submission used to request approval to market a medicinal product in the European Union and other regions that follow similar pathways.
The MAA includes clinical, nonclinical, and quality (CMC) evidence demonstrating safety, efficacy, and consistent manufacturing controls. Clinical trial data summarized in CSRs and integrated analyses form a major portion of the MAA evidence package. While IRBs do not approve the MAA itself, the evidence originates from ethically reviewed studies conducted under GCP. A strong MAA supports efficient regulatory review by presenting complete, traceable documentation across the product development lifecycle.