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In a significant regulatory update, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has announced a modification to the Official Mexican Standard NOM-059-SSA1-2015, which governs the Good Manufacturing Practices (GMP) for medicines. This update aims to facilitate the entry of innovative and essential biotechnological drugs into the Mexican market, particularly those for conditions like cancer and diabetes mellitus.

Background

NOM-059-SSA1-2015 was originally published on February 5, 2016, to establish minimum requirements for the manufacturing of medicines intended for human use. However the regulation has now been revised to align with international best practices, especially those recommended by the World Health Organization (WHO). The change follows the recognition that a large proportion of biotechnological medicines consumed in Mexico are manufactured abroad, and the existing requirement of obtaining a local GMP Certificate from COFEPRIS created unnecessary regulatory hurdles. 

Key Modifications

The revised NOM-059-SSA1-2015 introduces both additions and changes to existing sections:

New Definitions and Additions

• Point 3.128 defines biotechnological medicines and distinguishes between innovative and non-innovative (biosimilar or “biocomparable”) products.

• Point 3.129 introduces the concept of an Equivalence Agreement, which allows Mexico to recognize foreign technical regulations, sanitary measures, or conformity assessment results from trusted international authorities.

• Point 12.7 outlines that for imported biotechnological medicines (excluding vaccines), each lot must be approved by the responsible health authority before commercialization, either through document review or laboratory testing.

Modifications to Existing Provisions

• References to related standards such as NOM-073-SSA1-2015 (stability), NOM-164-SSA1-2015 (manufacturing for active ingredients), and NOM-220-SSA1-2017 (pharmacovigilance) were updated.

• Testing procedures now accept certificates of GMP or equivalent documents issued by recognized foreign regulators, including members of PIC/S and those listed under the WHO “List of Transitional WHO-Listed Authorities (WLAs)”.

• If a manufacturer already has valid GMP certification from recognized foreign authorities, only the manufacturer's analytical certificate needs to be submitted.

Purpose and Benefits

The modification establishes a formal Reliance Framework for imported biotechnological medicines, designed to:

• Accelerate market entry of high-quality therapies.

• Reduce duplication of regulatory efforts.

• Expand access to advanced treatments for Mexican patients.

• Support national health systems in acquiring timely and effective medicines.

By integrating international trust-based mechanisms, COFEPRIS aims to shift focus towards high-value national regulatory activities, including surveillance, distribution oversight, and pharmacovigilance.

Implementation Timeline

The updated regulation will enter into force on November 24, 2025 in the Diario Oficial de la Federación (DOF), setting a transition period for manufacturers and health institutions to adapt to the new framework. 

For more details, you can find the regulation (in Spanish) here. 

The Federal Commission for Protection Against Sanitary Risks (COFEPRIS) is currently conducting a risk analysis regarding the use of FD&C Red No. 3 in food, beverages, and pharmaceuticals. As Mexico’s national health authority, COFEPRIS continually evaluates food and pharmaceutical additives to ensure public safety and compliance with scientific and regulatory advancements.

International Considerations and Regulatory Review

COFEPRIS is actively assessing the impact of international regulatory decisions, including the recent revocation by the U.S. Food and Drug Administration (FDA) of FD&C Red No. 3 for certain uses. Taking these developments into account, COFEPRIS is performing a thorough risk assessment under the framework of Annex III, which governs colorants with an established Acceptable Daily Intake (ADI) in accordance with the Agreement on Food and Beverage Additives.

The ongoing review will determine whether modifications should be made to the existing list of permitted additives, considering scientific evaluations and international best practices. The process follows Article Fourteen of the Additives Agreement, which allows for the addition, exclusion, or extension of use of additives based on risk assessments conducted by multinational expert bodies. These include the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the Codex Alimentarius, and relevant regulations from the European Union and the United States.

Assessment of FD&C Red No. 3 in Pharmaceuticals

In addition to its use in food and beverages, COFEPRIS is evaluating the presence of FD&C Red No. 3 in pharmaceuticals. The agency has directed its scientific advisory body, the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM), to analyze the inclusion of this colorant within the FEUM’s chapter on pharmaceutical additives. The findings of this analysis will contribute to regulatory decisions regarding the continued use of this dye in medications.

Commitment to Public Health and Regulatory Transparency

COFEPRIS remains committed to safeguarding public health by continuously updating its regulatory framework based on scientific research and international developments.  COFEPRIS will implement any necessary regulatory adjustments following the conclusion of its risk assessment in the coming weeks. You can find the press release in Spanish here.