Mexico Regulatory News

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.

In a strategic move to prevent the illicit introduction of specific chemicals aimed at evading taxes on fuel, Mexico has announced robust regulatory measures. The temporary ban on 68 listed substances...

In a strategic move to prevent the illicit introduction of specific chemicals aimed at evading taxes on fuel, Mexico has announced robust regulatory measures. The temporary ban on 68 listed substances, coupled with recent updates to the List of Substances regulated by the Secretary of Energy, signals a comprehensive effort to secure the nation's energy landscape.

Under the revised list, the 68 substances implicated in fuel adulteration are now subject to heightened scrutiny. Notably, entities looking to import these substances must file for temporary import authorizations within 30 business days through the online system, VUCEM.

This development holds significant implications for companies operating in Mexico reliant on these substances for their daily operations. Staying informed and adapting to these new processes is crucial as Mexico fortifies its regulatory framework to safeguard against tax evasion tactics in the fuel sector.

In a significant move towards environmental sustainability, Mexico's Ministry of Environment and Natural Resources has taken a proactive stance by introducing a draft technical standard aimed at r...

In a significant move towards environmental sustainability, Mexico's Ministry of Environment and Natural Resources has taken a proactive stance by introducing a draft technical standard aimed at regulating the emissions of volatile organic compounds (VOCs) in production processes and auxiliary services. Published on July 17th, this standard signifies a crucial effort to curb pollution and mitigate the adverse effects of VOC emissions on both human health and the environment.

VOCs are a diverse group of carbon-based chemicals that can evaporate into the air and pose a significant threat to air quality. They are emitted from a range of sources including industrial processes, vehicle exhaust, and the use of solvents and paints. Once released into the atmosphere, VOCs can contribute to the formation of ground-level ozone and smog, both of which have been linked to respiratory issues and other health concerns.

The newly proposed draft standard lays out a comprehensive framework that industries operating within Mexico would need to adhere to, emphasizing the importance of reducing VOC emissions to safeguard public health and the environment. The heart of this standard lies in establishing annual threshold limits for various sectors operating in the country. These limits, measured in tonnes, would serve as a clear metric for industries to gauge their emission levels against.

However, merely setting limits is not the only aspect of the standard. The proposed framework goes beyond quantitative restrictions and delves into requiring industries to provide a comprehensive set of information to regulatory authorities. This information includes the list of equipment or activities emitting VOCs, technical specifications, functionality within the production process or auxiliary service, annual operating hours, and the list of solvents used along with their detailed chemical information.

Moreover, the draft standard acknowledges the importance of transparency and accountability. Industries falling within the ambit of this regulation would need to maintain an operations and maintenance log that documents daily and annual consumption of VOCs. These logs not only ensure consistent tracking of emissions but also serve as tangible records for monitoring compliance over time.

One notable aspect of the proposed standard is its forward-looking perspective. The authorities have recognized that emission reduction is a journey, not an instantaneous achievement. Therefore, the standard mandates industries exceeding the established emission thresholds to develop and implement a schedule outlining specific actions to reduce their VOC emissions. This provision aligns well with the global trend towards sustainable industrial practices and acknowledges that emission reduction is often a phased process that requires careful planning and execution.

Crucially, the Mexican government has also recognized the importance of public participation in shaping environmental policies. The draft standard is open for public consultation, inviting input and feedback from stakeholders and citizens alike. This inclusive approach ensures that the regulations are well-rounded, practical, and sensitive to the needs and concerns of various sectors of society.

For those interested in contributing, the window for submitting comments is open until September 15th.