Mexico Advances Clinical Trial Oversight Under Plan México

Mexican health authorities are advancing regulatory and ethical oversight of clinical research as part of the implementation of Plan México, according to actions presented by a permanent interinstitutional working group that brings together the country’s main health and regulatory bodies.

The Ministry of Health, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (CCINSHAE), and the National Bioethics Commission (CONBIOÉTICA) reported progress made through the Permanent Interinstitutional Board for Clinical Protocols. The meeting was led by Federal Commissioner Víctor Hugo Borja.

During the session, authorities detailed their coordination to support the publication of NOM-262-SSA1-2024 on Good Clinical Practices. The standard aims to strengthen regulatory certainty in clinical research and align national practices with international benchmarks. Officials also reported joint efforts to improve the standardized formats used by Ethics Committees, addressing inconsistencies that have affected evaluation processes.

The group highlighted actions to reinforce the role of research Ethics Committees in reviewing and approving informed consent forms. This includes clearer criteria and closer coordination among institutions involved in ethical oversight. In parallel, COFEPRIS and CONBIOÉTICA updated their collaboration agreements to streamline interinstitutional communication and reduce procedural delays.

Among the initiatives presented was the development of a training program for health researchers, designed to improve compliance with ethical and regulatory requirements. Authorities also reported progress on a pilot program focused on priority clinical research protocols promoted by CCINSHAE. Under this pilot, selected studies are expected to receive authorization within a 45-day timeframe.

Officials agreed to maintain the Permanent Interinstitutional Board for Clinical Trials as a coordination mechanism to monitor agreements, review regulatory formats, and strengthen ethical and regulatory evaluation systems. The board is expected to remain a central forum for aligning processes across institutions involved in clinical research oversight.

According to health authorities, the continued operation of the board consolidates a structured space for dialogue and coordination. This approach seeks to reinforce Mexico’s regulatory and ethical framework for clinical research, promoting more efficient, and transparent processes while prioritizing the protection of research participants and supporting access to innovation for millions of patients.

The developments take place amid a leadership transition at the COFEPRIS, reports MBN. In early January, President Claudia Sheinbaum announced a change in leadership at COFEPRIS, naming Borja as its new head. Borja replaces Armida Zúñiga and assumes the role as part of a transition the Ministry of Health says will prioritize continuity in regulatory work and public health protection.

The Ministry of Health says the leadership change aims to ensure an orderly transition and maintain ongoing efforts to safeguard the population from sanitary risks. COFEPRIS plays a central role in regulating medicines, medical devices, food, and other products with public health implications, making its leadership a key point of attention for the healthcare and life sciences sectors.

Borja brings an academic and professional background closely tied to epidemiology, public health, and risk assessment. He is a medical doctor who graduated from the UNAM and holds master’s degrees in public health and epidemiological sciences from the National Institute of Public Health. He also earned a doctorate in epidemiology from the University of North Carolina at Chapel Hill, reports Mexico’s Ministry of Health.

Over his career, Borja has held senior positions across key health institutions. Within the Ministry of Health, he served as the founding director of the National Center for Environmental Health and as director of risk analysis. At the Mexican Social Security Institute (IMSS), Borja led several coordination units and normative areas, including occupational health, epidemiological surveillance, public health, medical benefits, and primary healthcare. From these posts, he promoted preventive programs, strengthened epidemiological information systems and encouraged decision-making grounded in scientific evidence. 

The Ministry of Health says Borja’s technical background, management experience, and academic trajectory position him to further strengthen COFEPRIS’ regulatory role. The ministry reiterated its commitment to ensuring continuity in COFEPRIS’ work during the transition, underscoring the agency’s relevance for public health outcomes and regulatory certainty for industry.