What characterises a good Marketing Authorisation Application (MAA) - a clinical reviewer’s perspective

9:05 AM - 9:45 AM

A medicinal product may only be marketed in the European Economic Area (EEA) following a marketing authorisation from the competent authority of a Member State (or EEA country) for its own territory (national authorisation) - or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a community authorisation).
Both for the Applicant (the sponsoring pharmaceutical company) and the Medical Assessors, it is preferable that the assessment procedure is rapid to ensure quick market access to provide a safe and efficacious treatment option for patients. A good marketing authorisation application (MAA) is essential.
This session will provide information for what characterises a good MAA from a clinical reviewer’s perspective including information regarding the requirements for the different application procedures. The session will also present advice on how to prepare a good MAA, thereby increasing the likelihood of a smooth procedure and a positive opinion.