COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies

Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.

COFEPRIS x FDA: What Are the Key Differences in Medical Device Regulatory Pathways?

Companies looking to commercialize medical devices internationally often target two major markets: the United States and Mexico. These countries are regulated by two robust authorities — the FDA (Food and Drug Administration) in the U.S. and COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico — each with distinct regulatory frameworks.
Understanding the differences between FDA and COFEPRIS approval processes is essential for planning efficient market entry, minimizing risks, and reducing time-to-market. In this blog post, we provide a clear comparison of both regulatory systems, including requirements, timelines, and strategic advantages.

Mexico’s Modernized GMP Guidelines: Advancing Pharmaceutical Regulation

On March 20, 2025, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) implemented revisions to its Good Manufacturing Practice (GMP) guidelines to align with international regulatory standards and enhance global recognition. These updates are designed to optimize compliance processes, reduce administrative burdens, and strengthen the efficiency and competitiveness of Mexico’s pharmaceutical sector in the global market.

Mexico’s COFEPRIS Enhances New Molecules Committee to Accelerate Pharmaceutical Innovation

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has strengthened the expertise of its New Molecules Committee, a key regulatory body responsible for evaluating novel pharmaceutical agents. This initiative aims to enhance evidence-based decision-making, expedite drug approval processes, and expand public access to cutting-edge treatments. By integrating specialized experts, COFEPRIS seeks to streamline regulatory reviews and reinforce Mexico’s role as a leading hub for pharmaceutical research and innovation.
“The inclusion of these specialists will significantly enhance evidence-based decision-making with the highest scientific rigor,” stated COFEPRIS Commissioner Armida Zúñiga Estrada in a 14 March announcement. Furthermore, their work will have a direct impact on the availability of innovative treatments.

Mexican Ministry of Health Advances with SaMD

The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).

Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.

Mexico's Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.

On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023.   The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.