Significant Amedments to the General Health Law in Mexico 

January 20, 2026

The Federal Government published on January 15, 2026, significant amendments to the General Health Law in Mexico, aimed at strengthening health regulation across several key areas. Among the most notable changes are the new requirements for Health Research and Ethics Committees, which must now comply with stricter guidelines regarding their composition, operation, and formal obligations, including annual reports and reinforced criteria for selecting their members. The amendment also introduces new provisions on organ and tissue donation and transplants, focused on increasing public participation, facilitating the expression of donor consent, and reducing the national backlog of patients awaiting transplants. Finally, the degree establishes absolute restrictions and prohibitions on the commercialization, distribution, and importation of electronic cigarettes and vaping devices, a measure that tools effect on January 16, 2026, with the goal of protecting public health and limiting access to products considered high-risk.

1. In the area of health research

Below is a brief analysis of the most important points of this reform in the field of health research. The objective of these changes is to raise ethical standards, strengthen transparency, and improve the protection of research subjects in Mexico.

Mandatory Registration and Accreditation

The reform establishes that all health establishments conducting research on human subjects must have the following committees, which now require formal and valid accreditation:

• Research Ethics Committee.
• Research Committee.
• Biosafety Committee (in cases where genetic engineering techniques, radiation, or pathogens are used).

Supervision by the National Bioethics Commission

The National Bioethics Commission assumes a central role in this new scheme:

• It will be responsible for issuing the provisions and criteria under which these committees must be formed and registered.
• It will establish accreditation requirements to ensure that members have the necessary training to evaluate research protocols from an ethical and scientific perspective.

Transparency and Traceability

Under the new concept of traceability incorporated into the law, committees must keep rigorous records on:

The origin and destination of any biological samples used.
Detailed monitoring of informed consent processes.
The continuous monitoring of participant safety (pharmacovigilance and technovigilance).

Penalties and Compliance

It is essential to note that the reform introduces stricter penalties for establishments that operate without duly accredited committees or that fail to comply with professional ethics standards. Compliance with these requirements is now an indispensable condition for the legal validity of any clinical research project.

We hope this information is useful. Our Regulatory and Health Sciences team is ready to advise you on the transition process to these new provisions, ensuring that your research processes comply with the highest legal and bioethical standards.

2. In the area of organ donation and transplantation

Below we present a brief analysis of the most important points of this reform.

Gratuity and Altruism as Central Pillars

The law confirms that the donation of organs, tissues, stem cells, blood, and blood products is a strictly free act.

• Any type of trade or profit from these items is strictly prohibited.
• Donation must always be based on the principles of altruism, non-profit, and confidentiality.

New Definitions and Emerging Technologies

The reform updates key terms to adapt to scientific advances:

• Stem Cells: Specific regulations are established for banks and collection centers for these cells.
• Regenerative Medicine: This branch, focused on the repair and regeneration of cells and tissues through scientific evidence, is formally recognized.
• Traceability: This concept is introduced as the ability to locate and identify any organ or tissue from the moment of donation to its final destination or therapeutic use.
• Blood Products: These are defined as blood preparations with therapeutic use, including whole blood units, components, and mixtures thereof.
• Blood Derivatives: These are products obtained from plasma through physicochemical or biological processes for therapeutic, diagnostic, or preventive use.
• Residual plasma: Defined as plasma that, according to scientific evidence, is not suitable for direct clinical use in transfusion but can be used for industrial processes.

Donor Protection and Consent

Mechanisms are strengthened to ensure that the donor’s wishes are respected:

• The donation of stem cells from placental blood or umbilical cord blood requires a letter of informed consent from the pregnant woman.
• In the case of living minors, the removal of organs and tissues for transplantation is prohibited, with the sole exception of bone marrow or stem cells, always with the consent of their legal representatives.

Institutional Strengthening

The Ministry of Health, through the National Transplant Center and the National Blood Transfusion Center, will direct national policies and coordinate ongoing awareness campaigns to promote a culture of donation.

Industrialization of Residual Plasma.

Industrial use: The Ministry of Health shall determine the disposal of residual plasma existing in the country in order to obtain blood products for the benefit of the population.

National priority: The export of plasma for industrial processing may only take place if the national supply has first been guaranteed.

3. In the area of electronic cigarettes and vaping devices

Below we present a brief analysis of the most important points of this reform.

Which devices are regulated?

The law now technically defines electronic cigarettes, vaping devices, and similar systems as devices that heat or vaporize liquid substances, gels, salts, or synthetic mixtures (with or without nicotine).

Under this specific definition, we consider that tobacco heating devices are excluded from this ban, as their operation does not correspond to the vaporization of the liquid substances or gels described in the new regulations.

Marketing Restrictions

As of the effective date of this decree, the sale, production, distribution, and advertising of devices considered to be vaping devices or electronic cigarettes are prohibited throughout the country.

Any authorization or permit previously granted for these purposes is immediately revoked.

The marketing of these products now carries legal penalties, including fines and even the establishment of a crime punishable by one to eight years in prison.

Regarding personal use and consumption

End-user consumption is not penalized: The law establishes an explicit exception that allows the consumption and possession of these devices, provided they are not for commercial purposes.

Penalties are strictly directed at the marketing chain (sale, distribution, import, and advertising).

Our Regulatory and Health Sciences team is at your disposal to analyze how these reforms specifically impact your current projects and operations.

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