Author:
María de Jesús Medina Arellano, PhD
Institute of Legal Research, UNAM
México
Editor:
Lilia Carolina Leon-Moreno, PhD
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México
Introduction
Cell-based therapies – including CAR-T cell immunotherapies, mesenchymal stem cell (MSC) treatments, and other gene therapies involving stem cells – represent a rapidly advancing frontier in medicine. These innovative treatments hold great promise for conditions like cancer, degenerative diseases, and rare disorders. However, their potential also raises critical regulatory questions. In Mexico, the authorities face the challenge of fostering scientific innovation while ensuring patient safety and preventing unproven “miracle cures”. In previous reports, we have analyzed the landscape for Advance Medicinal Therapy Products in South and Central America. Nevertheless, our region is very complex, and every country has its own challenges and particularities. This brief report summarizes and provides an overview of Mexico’s current regulatory landscape only for cell therapies, serving as a watchdog analysis. The analysis is drawing on official regulations, policy statements, and scientific sources to highlight progress and gaps in oversight.
Legal bases and health authorities
Mexico’s regulation of cell therapies operates within the general framework of health law and is overseen by federal health authorities. The cornerstone is the General Health Law (Ley General de Salud), which mandates the Ministry of Health to support scientific research and sets broad requirements for any health interventions. The Federal Commission for Protection against Sanitary Risk (COFEPRIS, by its Spanish acronym), a decentralized arm of the Ministry of Health. COFEPRIS plays a role analogous to the U.S. FDA or European EMA, enforcing safety and efficacy standards for drugs, biologics, and novel treatments. Under Mexican law, any new biotech or cell-based therapy is treated as a health input requiring sanitary authorization to ensure it meets quality, safety, and efficacy criteria. There are several Official Mexican Standards (Normas Oficiales Mexicanas, NOMs) that complement the law by providing technical guidelines on tissues and cells. Unfortunately, these norms cover traditional areas like organ transplants and blood stem-cell (bone marrow) transplants. They do not explicitly address newer regenerative medicine applications. As a result, gaps remained in oversight of cutting-edge cell therapies – a void that authorities have been working to fill in recent years.
Research oversight
In México, any clinical use of human cells beyond established standard therapies must occur within a regulated research setting. This means hospitals or clinics offering experimental cell treatments must have an authorized research protocol, ethics committee approval, and COFEPRIS sanction before treating patients. In practice, COFEPRIS coordinates with other institutions like the National Bioethics Commission (for ethical review) and the National Health Council. One specialized agency, the National Center of Blood Transfusion (CNTS by its Spanish acronym), has a mandate to oversee the safe use of blood and cell therapies: CNTS proposes policies to ensure the rational and safe use of stem cells and maintains registries of cell therapy procedures, requiring institutions to report data on stem cell infusions and outcomes. This collaboration between COFEPRIS and CNTS helps create an additional layer of oversight.
COFEPRIS has acted against clinics offering unapproved stem cell treatments. Notably, in December 2015 COFEPRIS raided and shut down a private clinic in Mexico City that was advertising and administering mesenchymal stem cell (MSC) for unproven indications, without any approved research protocol or clinical trial, and failed to provide evidence of product quality (such as proper cell counts or viability testing). This enforcement set a precedent: any provider in Mexico offering cell therapy as a treatment (rather than within a formal trial) is operating outside the law. The Ministry of Health has similarly signaled zero tolerance for misleading stem cell “cure-all” claims. In the words of a top health official, Mexico is developing a regulatory framework to stop deceptive advertising and the misuse of stem cells, which promise cures for every disease without evidence. Mexican regulations thus far insist that such interventions remain investigational until proven safe and effective – echoing the World Health Organization’s stance that all unproven cell therapies must be considered experimental and used only in controlled trials or specialized centers.
Hospitals and research centers in Mexico that participate in cell therapy studies are subject to additional institutional regulations. The General Health Law’s Regulation on Health Research (Reglamento de la ley general de la salud en Materia de Investigación para la Salud) requires that any clinical investigation be overseen by an institutional ethics committee and, for therapies like cell transplants, by a hospital transplant committee. Indeed, Mexican health policy mandates that facilities performing human cell transplants (e.g. bone marrow or novel cell infusions) must have an internal Transplant Committee and appropriate specialist staff to ensure patient safety. They must also hold a license from health authorities to handle human cells. In 2023, the CNTS recommended tightening the licensing and registration of all establishments engaged in stem cell collection or therapy to ensure they meet standards. The centers are asked to submit monthly reports on any therapeutic use of stem cells, enabling traceability and oversight. Compliance with these reporting requirements has been an area for improvement – authorities are pushing for full data reporting in order to build national statistics and evaluate efficacy across institutions. In summary, at the federal and institutional level, Mexico has put in place a multi-tiered oversight system: COFEPRIS approval + ethics committee + transplant committee + CNTS monitoring are all required to legitimately perform advanced cell therapy on patients. However, it is well known that there are several – mostly private – clinics that held an approved Stem Cell Bank license
However, it is well known among the medical and scientific community that many clinics, mostly private, hold a duly approved health license for Stem Cell Banking but fail to meet the legal requirements. This license is granted solely for the banking of stem cells and does not include explicit authorization for expanding the cells beyond what is strictly necessary, let alone for their use in patients.
Unfortunately, in addition to failing to properly report all the samples they obtain and handle in their laboratories, these clinics take advantage of having this license to misleadingly advertise and falsely claim to patients that the health authority has authorized and approved their procedures for clinical application. Despite efforts to address this issue, it is evident that stricter oversight from regulatory authorities and specific regulatory framework is urgently needed.
Specific regulation
While general laws cover health research, Mexico has recognized the need for bespoke regulations for advanced therapies (a category that includes cell therapies, gene therapies, and tissue-engineered products). Until recently, regulatory coverage was fragmented and full of gray areas. Acknowledging this, the Ministry of Health (DOH) drafted a dedicated Official Mexican Standard: PROY-NOM-260-SSA1 (initially formulated in 2015 and updated in 2017) to specifically regulate the “disposition of stem cells and progenitor cells for therapeutic and research purposes.” This proposed (not approved yet) NOM-260 aims to establish clear rules for obtaining, processing, storing, and applying stem cells in therapy or trials. Experts from leading institutions (such as Cellular Physiology and Legal Research Institutes at UNAM) were involved in its development to ensure alignment with international quality and safety standards.
The draft NOM-260-SSA1-2017, though still pending approval, establishes strict regulations for stem cell research and therapies in Mexico. It mandates prior authorization from COFEPRIS for any clinical use, limits procedures to accredited institutions with qualified personnel, and prohibits premature marketing of unvalidated treatments. The norm also sets technical standards for cell processing and aims to curb false advertising by unregulated clinics. While not yet enforceable, COFEPRIS has been actively working on regulatory frameworks for advanced therapies, indicating progress toward safer and more standardized cell therapy practices in Mexico. One key move from COFEPRIS was the convening of a working group to develop regulations for advanced therapies (including gene therapies like CAR-T), with the aim of allowing Mexican patients safe access to these therapies. Nevertheless, it is important to highlight that most experts in the working group specialize in areas such as bone marrow transplantation or hematology, primarily focusing on the use of hematopoietic cells. It is imperative to integrate experts in stem cell therapy and gene therapy to ensure that all advanced therapies are properly included in the guidelines being developed.
The absence (so far) of a finalized NOM specifically for cell therapies has meant that Mexico’s oversight relies on general provisions and case-by-case judgments. This gap led to a period in which opportunistic clinics flourished by exploiting legal ambiguities. As Medina-Arellano (2018) analysis for CONACYT observed that Mexico’s laws and regulations contained many loopholes regarding stem cell research/use, leaving many activities in a gray zone of uncertainty. In that vacuum, Mexico “quickly became a destination for medical tourism” offering unproven stem cell interventions, with a proliferation of private clinics advertising stem cell cures under minimal regulation. This situation essentially turned Mexico into a hub for stem cell tourism, attracting international patients with promises of therapies for everything from Parkinson’s to spinal cord injury – often without credible scientific backing. Mexican regulators have recognized this problem. COFEPRIS’s participation in international forums (like the WHO-led workshop on advanced therapy regulations in 2024) and the emphasis on banning false advertising are direct responses. While awaiting the new NOM, COFEPRIS uses existing legal tools to oversee clinical trials and to sanction egregious cases. For example, it can invoke the General Health Law’s clauses on experimental medicine and the requirement that all new treatments prove safety/efficacy before general use. As previously stated, it also uses media communications to alert the public that any stem cell therapy outside of research is unauthorized and potentially unsafe. In effect, Mexico’s interim policy is that advanced cell therapies are restricted to clinical trials only – no clinic has carte blanche to treat patients for profit with these cells. The forthcoming NOM-260 is expected to cement this by formally regulating everything from cell banks to clinical applications and by empowering COFEPRIS to enforce specific standards in the burgeoning regenerative medicine field.
Approved therapies and ongoing research
Mexico is making significant strides in cell and gene therapy, balancing innovation with regulation. The first Mexican CAR-T cell therapy trial for leukemia is underway in Monterrey, potentially paving the way for homegrown treatments. Meanwhile, COFEPRIS has approved commercial CAR-T therapies for aggressive lymphomas, allowing patients access to cutting-edge treatments outside clinical trials. Hematopoietic stem cell transplantation remains a well-established practice, with over 770 transplants performed in 2023, including experimental applications for multiple sclerosis. These transplants operate within a tightly regulated framework, ensuring oversight and patient safety.
While mesenchymal stem cell (MSC) therapies remain unapproved for commercialization, research efforts persist, particularly in academic institutions. However, private clinics offering MSC infusions for conditions like autism remain controversial. Gene therapy is also gaining traction, with Mexico participating in international trials for hemophilia and cancer vaccines. These case studies highlight Mexico’s dual approach: embracing proven therapies while tightening regulations on unproven treatments. The country’s growing role in global research networks ensures it remains competitive in the rapidly evolving field of regenerative medicine.
Conclusion
The regulatory landscape for cell therapies in Mexico is undergoing significant strengthening and refinement. COFEPRIS has embraced a dual role: facilitator of innovation on one hand (guiding CAR-T and other trials through approvals) and guardian of public health on the other (shutting down illicit stem cell sales and banning false advertisements). The involvement of institutions like CONACYT and leading universities in policy development indicates a whole-of-system approach – marrying scientific expertise with regulatory policy to craft standards that are both rigorous and workable. Moreover, at the federal level, Mexico’s legal framework now recognizes advanced cell therapies as a distinct domain requiring oversight.
Despite the progress, challenges remain. Enforcing the ban on false advertising will require monitoring and there is also the challenge of capacity: reviewing advanced therapy applications is resource-intensive and requires cutting-edge expertise. COFEPRIS has begun strengthening its technical committees (for example, expanding its New Molecules Committee with specialized experts) to handle this workload. Continued investment in regulatory science and the inclusion of more experts in different areas of cell therapy is needed so Mexico can independently assess complex therapies rather than relying solely on foreign approvals.
Another ongoing task is building public and professional trust. Patients need to trust that if a stem cell therapy is offered in Mexico, it has passed muster and is not a sham. Healthcare professionals need clear guidelines on what they can refer patients to and which practices to avoid. Mexico’s initiative to publish data (like the CNTS report on stem cell usage) is a form of transparency that can inform the medical community and discourage off-protocol use by showing that the government is watching and evaluating outcomes.
In conclusion, Mexico’s regulatory environment for cell therapies in 2025 could be delineated as heightened regulatory oversight, alignment with international standards, and cautious integration of new therapies into practice. The country has gone from being a permissive environment by omission to a more regulated environment. Still, much work and cooperation among regulators and researchers is needed.