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Market Authorization

Meaning

Market Authorization, also known as regulatory approval or marketing approval, is the official permission granted by a national or regional regulatory body, such as the FDA or EMA, that allows a pharmaceutical product to be legally sold, distributed, and marketed for specific therapeutic indications. This critical step confirms that the drug or compound has been rigorously assessed for safety, efficacy, and quality based on extensive clinical trial data and manufacturing standards. It is the final gatekeeping step before a new hormonal therapy can reach the patient population.