Lilia Carolina Leon-Moreno, PhD
Postdoctoral Researcher
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ)
México

María de Jesús Medina Arellano, PhD
Institute of Legal Research, UNAM
México

Andrés Gómez De León, MD
Associate Professor
Hematology Service, Medicine Faculty, UANL
México

Toward an Advanced Therapies Framework in Mexico: Bridging Regulatory Gaps for ATMPs

The field of Advanced Therapies, which includes Cell Therapy, Gene Therapy, and Tissue Engineering, is rapidly transforming the landscape of medicine worldwide. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Brazil's ANVISA have made significant progress in establishing specific frameworks for these products, which are collectively known as Advanced Therapy Medicinal Products (ATMPs). In contrast, Mexico currently lacks a comprehensive and explicit legal framework for regulating these therapies.

In our previous SCA LRA Committee watchdog report (1), we analyzed existing instruments related to human cells, tissues, and organs that could serve as a foundation for regulating ATMPs. This follow-up piece proposes a reform roadmap aimed at aligning Mexico’s regulatory environment with global benchmarks—one that ensures safety, promotes innovation, and protects patients.

I. Strengthening the Legal Foundation for ATMPs

Mexico’s regulatory journey should begin with strategic reforms to its cornerstone health legislation: the Ley General de Salud (LGS, General Health Law) (2). While the LGS provides a broad framework for health-related activities, it must be modernized to explicitly incorporate ATMPs, enabling its safe, ethical, and evidence-based development. This should align with international best practices while leveraging Mexico’s existing institutional infrastructure. 

Key recommendations include:

• Legal Definitions: Introduce clear and harmonized definitions for ATMPs, drawing from EU Regulation 1394/2007, FDA’s 21 CFR Part 1271, and ANVISA’s RDC 476/2021. This would reduce ambiguity and facilitate consistent oversight.
• Dedicated Legal Provisions: Create a new section within the LGS focused on ATMPs (modeled after Title Twelfth: Control Sanitario de Productos y Servicios) to outline legal responsibilities for developers, manufacturers, and healthcare institutions, as well as setting specific criteria for clinical use outside the transplantation paradigm and distinguish between minimally manipulated and substantially manipulated products. This section could be titled Chapter IV Bis: Medicamentos de Terapias Avanzadas.
• Donation and Use of Cells and Tissues: Amend Title Fourteenth (Donación, Trasplantes y Pérdida de la Vida) to include a chapter on the donation of autologous and allogeneic cells and tissues for therapeutic use beyond transplantation.
  

II. Updating Federal Regulations

Mexico has several statutory (or secondary/specific/specialized) federal regulations derived from the General Health Law that govern the use of cells, tissues, and organs (3). However, these were not designed with ATMPs in mind and thus require targeted updates:

• Reglamento de la Ley General de la Salud en Materia de Investigación para la Salud: establishes ethical and methodological standards for health-related research, including studies involving human biological materials. This statutory norm should include provisions for first-in-human trials of gene or cell therapies and requirement on long-term follow-up protocols and gene modification safety data.
• Reglamento de la Ley General de la Salud en Materia de Control Sanitario de la Disposición de Órganos, Tejidos y Cadáveres de Seres Humanos: provides the sanitary control framework for the use and disposal of human tissues and organs, but does not account for minimally manipulated or manipulated cells for therapeutic purposes. This should include regulation of autologous/allogeneic cells and tissue-engineered constructs, as well as expand definitions to include viable cells for non-transplant therapeutic use.
• Reglamento de la Ley General de la Salud en Materia de Trasplantes: defines requirements for transplantation. However, this regulation should differentiate biologic transplants from cellular therapies, to avoid overlap and encompass the use of cell-based products outside of transplant paradigm. Also, it should clarify the legal route for autologous ATMPs, which do not involve donation per se.
  

III. Expanding the Scope of Normas Oficiales Mexicanas (NOMs)

Official Mexican Standards (NOMs, Normas Oficiales Mexicanas) complement the law providing technical guidelines (3). While current NOMs provide technical standards for traditional areas like organ transplants and related therapies, Mexico must develop a new NOM specifically for ATMPs. This NOM should draw from EU GMP Annex 2B and WHO ATMP guidelines, incorporating criteria for: viability, potency, and identity testing, viral vector quality control, traceability across collection, processing, and clinical use, among other quality and safety concerns around ATMPs. Also, the current NOMs should be reformed as follows:

• NOM-012-SSA3-2012 (Research ethics): needs to be updated to reflect the complexity and ethical nuances of gene, cell and personalized therapies.
• NOM-059-SSA1-2015/ NOM-164-SSA1-2015 (Pharmaceutical Manufacturing): these NOMs are currently used as a baseline for the production of every kind of medicinal product and must be updated to reflect the unique production needs of ATMPs
  
• NOM-257-SSA1-2014 (Biotechnology drugs): can serve as a technical foundation for regulating genetically modified cells but require expansion to include ATMP-specific criteria.
• NOM-241-SSA1-2012 (Medical Devices): while originally aimed at devices, this NOM could support the regulation of combination products such as scaffolds or delivery systems used in tissue engineering but must address the specific needs of live cell-based components.
  

Other relevant NOMs to be revised when ATMPs are fully incorporated into the pharmaceutical category include:

• NOM-072-SSA1-2012 (Labeling)
• NOM-073-SSA1-2015 (Stability)
• NOM-177-SSA1-2013 (Interchangeability)
• NOM-220-SSA1-2016 (Pharmacovigilance)
  

To promote global competitiveness and patient safety, the new framework should integrate the ICH Guidelines for quality and safety, WHO guidance on ATMPs (4), and standards from FACT, AABB, and ISCT for cell banking and clinical application.

IV. Reforming Licensing and Oversight

Currently, COFEPRIS grants sanitary licenses for the clinical use of cells and tissues (5). These can serve as a basis for more ATMP-specific licenses—but they require refinement:

• Reclassification of Establishments: Differentiate between stem cell banks, ATMP manufacturing centers, and tissue processors. Require GxP (Good Practices) compliance and formal inspections.
• Clear Licensing Pathways: Introduce licensing criteria aligned with international models like the EMA’s Manufacturing Authorization and FDA’s Biological License Application (BLA).
  

Training and Specialization: COFEPRIS staff must be trained in gene editing, cell expansion, and ATMP-specific GMPs. A dedicated division should oversee ATMP evaluations and maintain a public registry of clinical trials and authorized facilities.

V. Policy Implications: Supporting Ethical Innovation

A modernized legal framework would not only close regulatory gaps but also foster ethical innovation. It would disincentivize the spread of unregulated or unsafe therapies, support academic translation of research, and create avenues for international collaboration, investment, and technology transfer. Critically, these reforms would promote patient-centered development of cutting-edge therapies while ensuring rigorous ethical and lawful oversight, quality, and safety.

VI. Proposal: A Strategic Opportunity for Leadership

Mexico stands at a pivotal moment. Scientific and clinical stakeholders are already advancing novel cell and gene therapies, but the regulatory system has yet to evolve in parallel. Rather than starting from scratch, Mexico can build upon its existing infrastructure and modernize its framework to meet the demands of ATMPs. By doing so, it will not only protect patients and enable ethical evidence-based scientific practice but also establish itself as a leader in Latin America for the responsible development and global competitiveness of advanced biotechnologies.

References

1. Medina Arellano, María de Jesús (April 2025) https://www.isctglobal.org/telegrafthub/blogs/ken-ip1/2025/04/09/sca-lra-update-april-2025-regulatory-landscape-of, last date accessed: 26 of July 2025.  
2. Justia Mexico (2024). General Health Law. https://mexico.justia.com/federales/leyes/ley-general-de-salud/
3. A general outlook of the Mexican regulatory health system on genetic engineering technologies, see: Medina-Arellano, María de Jesus (2020). Human Germline Modification in Mexico. In: Boggio, A., Romano, C. P., & Almqvist, J. (Eds.). Human Germline Modification and the Right to Science: A Comparative Study of National Laws and Policies. Cambridge University Press.
4. Panamerican Health Organization. (2019). Regulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. https://iris.paho.org/handle/10665.2/51557
5. Federal Commission for the Protection against Sanitary Risks. (2025). Establecimientos de Servicios de Salud. COFEPRIS. https://www.gob.mx/cofepris/acciones-y-programas/establecimientos-de-servicios-de-salud