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Mutual Recognition Agreement

Meaning

A Mutual Recognition Agreement (MRA) is a formal, legally binding accord established between two or more independent regulatory authorities, such as national drug and medical device agencies, that permits the systematic acceptance of each other’s conformity assessment results. Within the pharmaceutical and hormonal product space, this critical agreement significantly streamlines the complex processes of drug approval, quality assurance, and market access by formally recognizing the validity of facility inspections and manufacturing standards conducted by the partner jurisdiction. The MRA fundamentally facilitates the international movement of safe, high-quality, and compliant medicinal products.