Submitting an MAA is a significant undertaking. Planning an MAA should start 2–3 years before submission to ensure adequate time to navigate the regulatory milestones and assemble all the dossier components.
This overview includes
- The key regulatory deliverables to complete before submitting a marketing authorisation application (MAA)
- The pre-submission MAA steps with timelines
- The drug evaluation process in Europe
- The drug evaluation timelines
- An overview of reference medicinal products and exclusivity benefits
- The EMA vs the Food and Drug Administration (FDA) drug evaluation process
- Information about Module 1 of the MAA dossier
How Somerville Development Partners can help medicine developers hoping to get a drug approved.
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