DDReg Pharma\’s Guide: Understanding the Drug Registration Process in Mexico
This DDReg Pharma article offers a strategic overview of the drug registration process in Mexico, a key pharmaceutical market in Latin America. It focuses on the role of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), the country\'s main regulatory authority. The guide breaks down the essential steps for gaining market approval, including the preparation of a comprehensive dossier with administrative, quality (CMC), non-clinical, and clinical data, all of which must be submitted in Spanish.