Cofepris

The Federal Commission for Protection against Health Risks (COFEPRIS) is the authority that monitors that all products with health impact - medicines, food, medical devices, cosmetics, tobacco, pesticides, and health services - comply with quality, safety, and efficacy standards before reaching the consumer. Key functions Registration and authorization Evaluates clinical studies, ingredients, and manufacturing processes. Issues health registrations that allow commercializing products in national territory. Inspection and surveillance Audits plants, laboratories, pharmacies, and food establishments. Takes samples and applies tests to detect contaminants or standard deviations. Import and export control Reviews certificates and labeling at customs. Grants prior permits for controlled substances and biologics. Product alerts and recalls Publishes risk notices and coordinates recalls when quality failures or adverse effects are detected. Innovation and digital procedures Recognition of "high-level" regulatory agencies to expedite approvals. Importance for transportation and logistics For companies like Control Terrestre, complying with COFEPRIS guidelines is vital when mobilizing pharmaceuticals, medical supplies, or food: Certified cold chain: temperature logs and monitoring devices to preserve product integrity. Tracking and traceability: transport guides and inviolable seals that guarantee cargo was not tampered with. Real-time documentation: customs documents, transport letters, and health permits available at the time of inspection. 2024-2025 Trends Greater COFEPRIS-FDA collaboration to harmonize criteria in North America. Surprise inspections based on risk analysis and AI use to detect non-compliance patterns. Boost to biotechnological and generic medicines; accelerated regulatory windows. COFEPRIS not only regulates, it also generates market confidence. For logistics actors, understanding and anticipating its requirements ensures smooth operations and protects public health, becoming a tangible competitive advantage.