What does CMC stand for in regulatory submission?

The term CMC in the context of regulatory submissions refers to Chemistry, Manufacturing, and Controls. This component is critical in the pharmaceutical and biopharmaceutical industries, as it encompasses the detailed information about the product's composition, the manufacturing processes, and the quality controls applied to ensure the product's consistency, safety, and efficacy.

In regulatory submissions, the CMC section provides vital data regarding the active pharmaceutical ingredients (APIs), the methods of synthesis and manufacturing, specifications for raw materials and finished products, stability studies, and packaging information. This ensures that regulatory authorities can assess the adequacy of the product's manufacturing process and its compliance with established standards.

Understanding CMC is essential for stakeholders involved in drug development and regulatory affairs, as it directly impacts the approval process and the subsequent marketability of a pharmaceutical product.