Market authorization

What is market authorisation?Market authorisation is the formal approval granted by a regulatory authority that allows a medicinal product to be marketed and sold within a specific jurisdiction. It confirms that the product has met predefined standards for quality, safety, and efficacy. Examples include the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).What happens after market authorisation?Achieving market authorisation is a major milestone but not the end of the process. After approval, companies must secure reimbursement, negotiate pricing, and engage stakeholders to ensure patients can access the product. Post-authorisation commitments such as safety monitoring and real-world evidence generation also continue throughout the product’s lifecycle.