Mexico Drug Registration Process via COFEPRIS

📢 DDReg Knowledge Capsule – Episode [8]In-depth guide to the drug registration process in Mexico, highlighting its importance as the second-largest pharmaceutical market in Latin America. The core of the process is overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which categorises medicines into distinct regulatory pathways, such as New Chemical Entities and generics, each with different timelines and requirements. Key strategic elements for successful market entry include submitting all required documents in Spanish, appointing a mandatory local legal representative ("responsable sanitario"), and adhering to Good Manufacturing Practice (GMP) standards.