Mexico Regulatory News

In a sweeping move to enhance regulatory efficiency, the Mexican government has announced on the 11th of July 2025 new measures aimed at simplifying the processes associated with health-related permit...

In a sweeping move to enhance regulatory efficiency, the Mexican government has announced on the 11th of July 2025 new measures aimed at simplifying the processes associated with health-related permits and certifications. The action, formally published in the Diario Oficial de la Federación on July 11, 2025, outlines a comprehensive framework for the reduction of bureaucratic hurdles, with a focus on improving the speed and accessibility of health-related licensing, certification, and approval processes.

Key Highlights of the New Regulations

1. Simplification of Trams and Services:
   The agreement establishes a series of steps to reduce the administrative burden for businesses and health establishments. Among the most notable changes is the introduction of "immediate resolution" modalities for several previously complex processes, including the modification of sanitary registrations for medical devices and pesticides. This marks a shift towards more responsive and flexible service delivery by regulatory bodies.

2. Reduction of Processing Times:
   The new framework significantly reduces processing times for key regulatory procedures. For example, the time to process modifications to pesticide registration has been halved, from 30 days to just 15 days. These cuts are intended to accelerate approvals, facilitating faster market access for critical health and safety products.

3. Shift to Notification-Based Systems:
   In a progressive step towards modernizing regulatory oversight, the Mexican government is moving from authorization-based systems to a notification-based approach for many health-related activities. Companies will now only need to notify the authorities of certain activities, such as the operation of health facilities, rather than awaiting explicit approval. This change is expected to significantly cut down on waiting times and reduce administrative overhead.

4. Improved Regulatory Clarity and Transparency:
   The regulations also introduce clearer guidelines on what constitutes necessary documentation for various processes. This includes eliminating redundant paperwork and streamlining the approval procedures for health-related establishments. By simplifying the submission process, the government hopes to reduce the potential for errors and delays.

5. Boost for Economic Activity:
   The regulatory changes are designed not only to improve efficiency but also to stimulate economic growth by encouraging the rapid deployment of health and safety products. This move is particularly relevant in the wake of growing global demand for medical devices, pharmaceuticals, and related health products, which require quick and predictable regulatory processes.

6. Future Modifications and Monitoring:
   The new rules allow for continuous improvements, with the Commission for the Protection against Health Risks (COFEPRIS) empowered to introduce further adjustments as needed. This adaptive approach ensures that the regulations remain responsive to evolving health challenges and industry needs.

What This Means for Businesses and Health Institutions

With the introduction of these measures, businesses in the health sector, including pharmaceutical manufacturers, medical device producers, and health service providers, can expect faster turnaround times and clearer instructions for regulatory compliance. This reform reflects a broader commitment to regulatory modernization, aligning Mexico’s public health oversight with international best practices. These changes are set to take effect within the next few weeks, with the full implementation of immediate resolution procedures and online processing expected within 30 days for most sectors. For futher details, you can consult the Agreement (in Spanish) here. 

In an effort to streamline the regulatory processes for health products, the Mexican government has introduced new guidelines on July 18, 2025 aimed at simplifying the registration of medical supplies...

In an effort to streamline the regulatory processes for health products, the Mexican government has introduced new guidelines on July 18, 2025 aimed at simplifying the registration of medical supplies and pharmaceuticals. The initiative, published in the Diario Oficial de la Federación (DOF), marks a significant step towards enhancing the efficiency and accessibility of healthcare products in Mexico.

The newly issued Lineamientos Generales (General Guidelines) establish an abbreviated regulatory pathway for health product registrations. This approach will recognize the equivalence of requirements, tests, and evaluation procedures set forth by international regulatory authorities, including the World Health Organization's (WHO) Prequalification Program. By doing so, Mexico aims to improve the speed of approving health products while maintaining rigorous safety and efficacy standards.

Key Features of the New Guidelines

The Lineamientos Generales focus on two main types of health products: medications and medical devices. The guidelines define procedures for recognizing approvals granted by other established authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and WHO-recognized agencies.

1. Medication Registration: The new process will apply to various types of pharmaceuticals, including new molecules, generics, and biotechnological products. For these, the evaluation criteria and technical documentation will align with the standards of recognized international authorities, such as the FDA, EMA, and WHO.

2. Medical Devices: Similarly, medical devices will be eligible for expedited registration when certified by recognized authorities such as the International Medical Device Regulators Forum (IMDRF). The guidelines also establish that regulatory decisions made by these bodies can be used to approve medical devices for use in Mexico, simplifying the approval process significantly.

Streamlined Process to Boost Health Product Availability

David Kershenobich Stalnikowitz, Secretary of Health, emphasized that the new system aligns with global best practices and will help ensure that essential health products are available more quickly to the Mexican population. "This initiative not only reduces bureaucratic hurdles but also strengthens Mexico's regulatory framework, ensuring that only safe, effective, and high-quality products reach the market," Kershenobich stated.

Under the new guidelines, pharmaceutical companies and medical device manufacturers will not be required to submit duplicate documentation. The evaluation process will be considerably faster, with a 45-day maximum deadline for medications and 30 days for medical devices, subject to compliance with the new regulations.

Changes to Existing Frameworks

The guidelines supersede previous agreements and provisions that allowed for recognition of foreign regulatory approvals. These updates aim to further clarify the regulatory path for health products imported into Mexico. By recognizing the equivalence of foreign evaluations, the Mexican government hopes to enhance its reliance on international standards while maintaining stringent oversight to protect public health.

Implementation Timeline

The new regulations will come into effect 30 days after their official publication in the Diario Oficial de la Federación, expected to be in mid-August. As part of the implementation process, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) will ensure that no additional documentation is required from applicants beyond the established guidelines. This move is expected to significantly reduce the time and cost associated with bringing medical products to market in Mexico.

Transition and Future Implications

With these new guidelines, Mexico is positioning itself to further integrate into global health product markets, offering more streamlined access to international companies looking to distribute their products in the region. The measures align with Mexico's commitment to improving public health standards while reducing regulatory delays. For further details, you can consult the Agreement (in Spanish) here. 

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 g...

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�...

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.

In a move aimed at enhancing environmental protection and regulating the import and export of hazardous substances, Mexico has amended its regulatory framework for the Control of Pesticides, Fertilize...

In a move aimed at enhancing environmental protection and regulating the import and export of hazardous substances, Mexico has amended its regulatory framework for the Control of Pesticides, Fertilizers, and Toxic Substances (CICOPLAFEST). These amendments, published in the Official Gazette of the Federation on March 14, 2024, came into effect 30 days after the publication and represent a significant change in Mexico's environmental regulatory landscape.

The revised agreement introduces several modifications and additions to various articles and annexes, notably impacting the classification, verification, and exportation procedures for substances falling under CICOPLAFEST. Below are the key highlights of the amendments:

1. Updated Definitions:

• The inclusion of the acronym for PROFEPA (Federal Attorney for Environmental Protection) broadens the range of regulatory entities involved in overseeing environmental compliance.

• The refinement of the "Regulation" description now includes references to the "Verification Registry," in addition to existing authorization and permit requirements, reflecting a more comprehensive regulatory approach.

2. Enhanced Verification Requirements:

• Addition of the mandate for verification and compliance with the PROFEPA verification registry for goods listed in Annex I underscores the government's commitment to ensuring adherence to environmental standards at entry and exit points.

• The requirement for attaching digital or electronic documentation to customs declarations streamlines verification processes and enhances transparency in regulatory compliance.

3. Goods Subject to Compliance with CICOPLAFEST:

• Annex I now incorporates a new homoclave system, introducing a standardized method for identifying substances subject to regulatory oversight.

• The classification of goods into distinct categories, including pesticides, toxic substances, and fertilizers, facilitates targeted regulatory measures tailored to specific environmental risks associated with each category.

4. Clarified Exportation Procedures

• Export procedures for substances outlined in Article Four, Annex II are clearly outlined, ensuring exporters are aware of their compliance obligations, minimizing regulatory ambiguities.

• Specific mention of goods not covered in Annex I underscores the necessity for export authorization, eliminating potential loopholes in oversight mechanisms.

These regulatory amendments represent a significant step forward in Mexico's efforts to strengthen environmental protection measures and promote sustainable development practices.

Stakeholders across affected industries are urged to familiarize themselves with the amended regulations and take proactive steps to ensure compliance within the stipulated timeframe.

On March 14, 2024, the "Agreement amending the previous one that establishes the goods whose import and export are subject to regulation by the agencies that make up the Intersecretarial Commission fo...

On March 14, 2024, the "Agreement amending the previous one that establishes the goods whose import and export are subject to regulation by the agencies that make up the Intersecretarial Commission for the Control of the Process and Use of Pesticides, Fertilizers and Toxic Substances" was published in the Official Gazette of the Federation. This reform will come into force 30 calendar days after its publication. 

The main modifications and additions focus on articles Two and  Eight, and Annexes I and II, highlighting the following points: 

I. Definitions (Article Two): 

• The acronym for PROFEPA (Federal Attorney for Environmental Protection) is added. 

• The description of "Regulation" is modified to add the reference to the "Verification Registry," in addition to the authorization and permit already mentioned. 

II. Goods subject to verification (Article Eight): 

• The requirement of verification and compliance with PROFEFA's verification registry is added for goods listed in Annex I. 

• Interested parties in regulated goods must prove compliance at entry and exit points of the country, attaching the digital or electronic document to the customs declaration. 

III. Goods subject to compliance with CICOPLAFEST (Annex I): 

• The homoclave PROFEPA-03-004-D is added to Annex I for goods subject to compliance with the verification registry. 

• The number of tariff items included for each type of goods is specified, including pesticides, toxic substances, fertilizers, and plant nutrients. 

IV. Procedure for the export of substances mentioned in Article Four (Annex II): 

• It is clarified that goods not listed in Annex I, Section d), will be subject to export authorization. 

These modifications represent an important step in strengthening the regulation and control of pesticides, fertilizers, and toxic substances, thus ensuring environmental protection and public health in Mexico. 

Mexico has recently released a crucial compilation known as the "List of Frequently Transported Hazardous Substances and Materials" slated to entirely replace the previous 2011 version within the next...

Mexico has recently released a crucial compilation known as the "List of Frequently Transported Hazardous Substances and Materials" slated to entirely replace the previous 2011 version within the next 60 days, by February 16, 2024.

This new iteration of the Official Mexican Standard (NOM) serves as a comprehensive guide for identifying hazardous goods during transportation. It includes information such as their class, hazard division, secondary hazard, UN-assigned numbers, specific provisions governing their transportation, quantitative limits for limited and excepted quantities, and detailed instructions for packaging usage.

The scope of this NOM extends to shippers, carriers, and consignees involved in the transportation of hazardous goods via land, air, or sea. It encompasses various types of containers and packaging, including packages, large packages, intermediate bulk containers, large containers and packaging, portable tanks, multi-element gas containers, and bulk containers, each subject to their own set of special provisions outlined in the standard.