On November 27, 2025, the State of Mexico hosted a Legislative Roundtable dedicated to analyzing and projecting the regulatory framework for blood derivatives, in the context of the reform to the General Health Law. The alignment of policies, infrastructure, talent, and regulation is shaping up as the foundation for a future state policy aimed at transforming the management and utilization of blood derivatives in Mexico. The central purpose was to advance towards a comprehensive national policy that allows for the strategic use of residual plasma and to consolidate the production of blood-derived medicines within the country. The event took place at a historic moment for Mexican public health, as the country currently hosts the only plasma fractionation plant in Latin America, a facility operating under international Good Manufacturing Practice (GMP) standards. This advance implies a structural transition in the national production of immunoglobulins, albumin, and other essential blood derivatives, introducing a transformative potential for both supply and pharmaceutical sovereignty. Findings and consensus from the roundtable identified ten priority axes for building a National Plan for Blood Derivatives, aimed at strengthening the entire chain from donation to industrialization and therapeutic use. These axes include: increasing altruistic blood and plasma donation through sustained campaigns to overcome the current 8% voluntary donation rate and ensure sufficiency for the national industry; implementing a centralized national coordination for blood banks, hospitals, and donation centers to ensure traceability, cold chain, and efficient use of residual plasma for industrialization; consolidating national fractionation plants that comply with GMP standards, strengthening infrastructure, technical talent, certifications, and processing capacity in Mexico; modernizing and reinforcing the regulatory framework to ensure quality, ethics, and security throughout the plasma chain from collection to pharmaceutical use; leveraging residual plasma, currently largely discarded, to achieve economies of scale, reduce costs in consolidated purchases, and improve the efficiency of public spending on plasma-derived medicines; developing national traceability and pharmacovigilance systems to accompany the processes of collection, industrialization, and distribution; aligning public and private investment with solid regulatory policies to ensure quality, safety, and equitable access to blood derivatives; promoting the training of specialized talent through national training and certification programs linked to blood banks and fractionation plants; articulating donation, logistics, infrastructure, regulation, investment, and technological innovation within a long-term vision National Plan for Blood Derivatives; and promoting a sustainable and self-sufficient model in which residual plasma is consolidated as a strategic input for the Mexican health system. The roundtable underscored that Mexico has the necessary elements to transition to an integral, self-sufficient, and sustainable model for the production of blood derivatives. The existence of a national GMP-standard plant, unique in the region, is positioned as a strategic asset that would guarantee supply, reduce import dependence, lower costs, boost the sector's industrial development, and strengthen the National Health System.
Lawmakers, Experts, and Health Sector Advance in Regulatory Framework Modernization
A legislative roundtable in Mexico was held to analyze the regulatory framework for blood derivatives. The country, with the only plasma fractionation plant in Latin America, is advancing a national policy to ensure supply sovereignty and create a sustainable health model.
