Cofepris: A Vital Regulatory Agency for Mexico’s Economic Development
The Federal Commission for Protection against Health Risks (Cofepris) plays a crucial role in Mexico’s economic development by overseeing sectors that contribute up to 17% of the country’s Gross Domestic Product (GDP). These sectors include medicines, food and beverages, pesticides, the fishing industry, chemicals, and toxic substances. With 17 key sectors under its purview, Cofepris ensures the safety and regulation of products that impact public health and economic growth.
Budgetary Challenges and Negotiations with Hacienda
Cofepris operates on an annual budget of approximately 800 million pesos through the Federal Budget of Expenditures (PEF). However, the agency generates additional revenue from regulatory fees, totaling 1.5 billion pesos in 2024. The Finance Ministry (Hacienda) returns 50% to 60% of these funds, a unique financing model in the health sector. Dr. Armida Zúñiga, Cofepris’s commissioner president, emphasizes the need for a larger proportion of returned funds to support both health protection and economic growth.
Zúñiga highlights the importance of updating Cofepris’s legal framework for modernization, which requires resources. For instance, without proper travel allowances for foreign plant inspections, such as those in Japan or India, the consequences include unavailable resources for the population and hindrances to economic progress.
Simplification and Digital Transformation Efforts
Cofepris is working to simplify and digitize its processes, aiming for greater efficiency. Dr. Zúñiga stresses the importance of simplifying bureaucracy before digitizing it. The agency has published 11 simplification agreements addressing 340 complex procedures, with 237 already simplified by eliminating redundant bureaucracy.
Cofepris collaborates with the Digital Transformation Agency, led by José Merino, to digitize processes by 2026. This collaboration aims to reduce processing times and redundancies through weekly trainings for staff and regulated parties on digital platforms.
Accelerated Clinical Trial Protocols
In a critical area for pharmaceutical innovation, clinical trial protocols have seen significant improvements. Average processing times dropped from 9 months to 40-45 days in 2025, with some cases receiving approval within 21 days. Cofepris works with academia, industry, and entities like Conbioética to avoid redundancies and dispel misconceptions about regulatory bottlenecks.
Pfizer Vaccine Case Study
Dr. Zúñiga clarifies misconceptions surrounding the Pfizer COVID-19 vaccine. There are no differentiated processes for public or private sector vaccines; however, traceability requires specifying the distribution channel. Pfizer received updated strain registrations in August 2025, similar to Moderna. Delays in private sector sales were due to Pfizer’s commercial strategy, not Cofepris’s regulatory actions.
Cofepris’s Infrastructure and International Collaboration
During a visit to Cofepris laboratories, the extensive infrastructure and technical capabilities of the National Reference Laboratory were evident. Cofepris aims to join the World Health Organization’s (WHO) List of Authorities Regarded as Trusted (LART) through good practices and processes (GBT). Dr. Zúñiga signed agreements with EMA, Swissmedic, and others during an October European tour to facilitate joint reviews and capacity building in biotechnology.
Cofepris also promotes a Latin American health agency, initially with Brazil and Colombia, to strengthen post-pandemic supply chains. The regulator is advancing in “reliance” agreements with other national regulatory authorities (ARN) to trust their evaluations, reducing approval times without ceding sovereignty.
“We Will Eliminate the Backlog by 2026”
Dr. Zúñiga addresses the backlog in procedures, partly caused by insufficient resources. Cofepris quantifies progress with new molecules, licensed establishments, medical devices, and pesticides at 80% and 40% for medications, respectively. The goal is to close the historical backlog in the first quarter of 2026, prioritizing high-risk areas through one-on-one industry engagement.
Modernization of Regulatory Framework
In line with the Health Sector Program, Cofepris is tasked with modernizing its institutional structure and regulatory improvements that had been neglected for years. Ten official norms have been updated with academic (UNAM, UAM, IPN) and sectoral support, including clinical best practices and labeling regulations.
Regulations like RIS (health care inputs) and Plafest (pesticides) are ready for legislative submission, while Cofepris itself is being updated. The agency also works on topics like reducing lead levels in toys, ceramic tiles, and food additives (e.g., red 3) to align with WHO guidelines.
Regulation of “Well-being Pharmacies”: The Issue Was in the Announcement
When asked about regulating “Well-being Pharmacies,” Dr. Zúñiga explains they are not independent modules but delivery spaces for dry medications (diabetes, hypertension) under the Salud Casa por Casa program. These centers are regulated by operational permits, not licenses, and do not handle controlled or biological drugs.
The initial announcement did not help, as personnel are trained and manualized. These centers aim to facilitate access for vulnerable populations in the Casa por Casa program, such as older adults and people with disabilities, without long lines.
Cofepris and IMPI: The Challenge of Expanding Access to Generics
Cofepris’s collaboration with the Mexican Institute of Intellectual Property (IMPI) has led to reduced response times for patent consultations, now answered within 10 days instead of months. A platform for increased agility and transparency is being developed.
Mexico must prioritize generic drug access to reduce therapy costs, despite patents no longer existing in Mexico. Dr. Zúñiga emphasizes supporting local production, citing the hemoderivatives plant (Mexico’s first) and API projects, all with regulatory support (OTE) similar to the U.S. FDA’s Scientific Advice and Europe’s EMA.
