What do you mean by CMC in Regulatory Affairs?

In the context of Regulatory Affairs, CMC stands for Chemistry, Manufacturing, and Controls. It refers to the technical and regulatory aspects of drug development and production, which includes the chemical composition of the drug substance, its manufacturing process, and the controls in place to ensure its quality and consistency.

The CMC section of a regulatory submission typically includes information about the drug substance and drug product, such as their physicochemical properties, methods of manufacture, specifications, stability data, and analytical methods used to test the product.

The CMC information is critical for regulatory authorities to assess the safety, efficacy, and quality of a drug, and to determine whether it meets the requirements for approval and marketing authorization. Therefore, it is essential for pharmaceutical companies to provide complete and accurate CMC data in their regulatory submissions.

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