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In regulatory affairs, CMC stands for Chemistry, Manufacturing, and Controls. It refers to the comprehensive documentation that details the composition, manufacturing processes, quality control measures, and stability of a pharmaceutical product. CMC information is crucial for regulatory agencies to assess the safety, efficacy, and quality of a drug before granting approval for market authorization. It ensures that the product is consistently produced to the required standards and that its quality is maintained throughout its shelf life. Proper CMC documentation is essential for demonstrating compliance with Good Manufacturing Practices (GMP) and for facilitating the review process during drug approval submissions.