The innovation pipeline in Mexico’s food, biotech and pharmaceutical sectors

Cecilia Stahlhut Espinosa
Hogan Lovells, Mexico City
cecilia.stahlhut@hoganlovells.com

Introduction

Mexico’s life sciences sector stands at a regulatory crossroads that could redefine how innovation develops across the country. Traditionally marked by complex, bureaucratic and often rigid regulatory frameworks, the current moment presents a critical opportunity for regulatory transformation.

Amid global trends favouring smarter regulation, increasing international alignment, the rise of digital technologies and a growing emphasis on risk-based governance, Mexico is being called to action. In response, key regulatory institutions, particularly the Federal Commission for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios or COFEPRIS), are pursuing policy shifts aimed at renewing the rules governing the food, biotech and pharmaceutical sectors. These reforms could unlock significant additional investments in Mexico’s life sciences sector, strengthening the country’s competitive position in regional and global markets.

This article explores how these regulatory and industry changes are modernising regulatory oversight and fostering innovation throughout the life sciences landscape. Most importantly, it highlights the sectors within the industry that stand to benefit most from a renewed, innovation-driven regulatory approach that aligns more closely with international standards.

The historical context and current challenges

The life sciences regulatory framework in Mexico is primarily governed by the Ministry of Health through COFEPRIS, which oversees food safety, pharmaceuticals, medical devices and biotechnology. The National Service for Agro-Alimentary Health, Safety and Quality (Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria or SENASICA) (), the Federal Consumer Protection Agency (Procuraduría Federal del Consumidor or PROFECO) and the Ministry of Environment and Natural Resources (Secretaría del Medio Ambiente y Recursos Naturales or SEMARNAT)  also play complementary roles in regard to food regulation, biotechnology, consumer protection, technology risks and environmental compliance.

While the regulatory landscape has historically faced challenges related to over-regulation, excessive requirements, lengthy approval timelines and poor interagency coordination, Mexico is now positioned for transformation. Recent years have seen an accelerating push towards regulatory coherence, digitalisation and alignment with international standards, developments that open up promising new avenues for innovation and cross-jurisdiction collaboration.

Catalysts for regulatory transformation: international connections and global regulatory trends

Mexico’s regulatory evolution in life sciences is increasingly shaped by global trends, industrial factors and international engagements that serve as powerful drivers for positive change. Mexico’s regulatory modernisation efforts are occurring against a backdrop of significant global shifts in life sciences oversight. These international connections provide both momentum and direction for Mexico’s regulatory modernisation efforts.

International trade agreements as regulatory catalysts

The United States–Mexico–Canada Agreement (USMCA), which took effect in 2020, represents an important driver of regulatory improvement, with specific provisions for life sciences cooperation.

Beyond North America, Mexico’s updated trade agreement with the European Union and its participation in the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) create additional frameworks for regulatory alignment. These include protocols for mutual recognition of good manufacturing practice (GMP) inspections and provisions encouraging the adoption of international standards.

Pan American convergence initiatives

A major catalyst for Mexico’s regulatory modernisation has been its active participation in Pan American Health Organization (PAHO) convergence initiatives. COFEPRIS has been significantly involved in PAHO’s regional efforts to strengthen regulatory systems and harmonise requirements across Latin America. The IX Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) provided a platform for Mexico and other regional regulators to align their approaches to key challenges, including regulatory reliance, pharmacovigilance, drug supply chains and the regulation of biologics.

Mexico’s designation as a National Regulatory Authority of Regional Reference (NRA-RR) by PAHO has positioned COFEPRIS as one of eight leading agencies in the Americas, creating pathways for regulatory cooperation with other countries in the region. This reference status facilitates knowledge sharing and establishes mechanisms for regulatory reliance that benefit both Mexico and neighbouring countries with less developed regulatory systems.

Cross-Border regulatory reliance mechanisms

The implementation of reliance pathways for products evaluated by recognised authorities (the US Food and Drug Administration, the European Medicines Agency and select Latin American agencies) has resulted in significant improvements in approval predictability and faster approval pathways.

Expanding these pathways to include innovative product categories and certain biotechnology applications creates strategic advantages through regulatory reliance and mutual recognition. Companies with global portfolios can design parallel expansion strategies that capitalise on cross-border recognition of product lifecycle aspects and approvals. This approach reduces duplication, speeds up market access and creates opportunities for synchronised global product launches, while maintaining regulatory compliance across multiple jurisdictions.

International harmonisation and risk-based approaches

The global movement towards regulatory harmonisation provides crucial frameworks for Mexico’s modernisation efforts. Mexico’s acceptance as an International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Observer and its subsequent implementation of key guidelines represents significant alignment with international best practices.

World Health Organization (WHO) regulatory frameworks, particularly the WHO Global Benchmarking Tool for the evaluation of national regulatory systems, have provided Mexico with standardised metrics for measuring regulatory performance. COFEPRIS’s implementation of the WHO’s good regulatory practices and good reliance practices has enhanced its consistency with global approaches, while maintaining decision-making sovereignty.

Leading regulatory authorities are increasingly embracing risk-based approaches that focus oversight on higher-risk products, while streamlining requirements for lower risk ones. This strategy not only preserves safety standards, but also provides controlled regulatory flexibility, fostering innovation and allowing regulators to focus their efforts on emerging technologies and evolving markets. As Mexico evaluates suitable oversight models for novel products, from cosmetics to food and pharmaceuticals, these international practices offer valuable guidance.

Analysis of specific industries

The food Industry

Mexico’s food regulatory framework presents significant opportunities for strategic development, particularly through collaborative approaches with regional leaders like Brazil. While important regulatory gaps remain, these represent opportunities rather than merely challenges.

Mexico’s legal framework continues to focus primarily on conventional food products. While food labelling regulation has benefited from updates, these have centred on warning labels for excess calories, sugars and fats, rather than provisions for innovative ingredient claims. The regulatory pathway for communicating novel food benefits to consumers remains largely undefined.

The current regulatory gaps in Mexico’s framework for novel, functional foods and nutraceuticals present an ideal opportunity for establishing harmonised standards with other Latin American markets. By working collaboratively with regional partners, Mexico can develop a regulatory approach that facilitates cross-border trade, while ensuring appropriate safety standards.

Industry stakeholders across the region would benefit from such harmonisation through reduced compliance costs and expanded market opportunities. Rather than developing regulations in isolation, Mexico has the opportunity to lead a coordinated regional effort that leverages the collective experience and scientific expertise across Latin America, with Brazil’s established framework serving as a valuable foundation for this collaborative approach.

Biosafety regulations for genetically modified organisms (GMOs)

Despite the Mexican government’s protective restrictions on certain GMO categories like maize and corn, other genetically modified food products remain permitted and have received several favourable responses from COFEPRIS, in conjunction with other authorities, recognising the relevance of GMO technologies. The implementation of the Biosafety Law for Genetically Modified Organisms (Ley de Bioseguridad de Organismos Genéticamente Modificados or LBOGM) continues to evolve, with recent amendments focusing on streamlining risk assessment procedures.

Mexico maintains a case-by-case evaluation approach for non-restricted GMOs, allowing for scientific assessment of the safety of such products, while balancing cultural and environmental considerations. Additionally, recent trade agreements have created pressure in regard to the creation of harmonised regulatory frameworks across North America, potentially influencing future policy decisions regarding biotechnology acceptance and regulation.

Frameworks for emerging biotechnologies

Recognising the limitations of GMO-focused regulations for newer technologies, the Mexican authorities have begun developing specific frameworks for emerging biotechnologies. The COFEPRIS/SENASICA joint technical consultation on gene editing technologies established that certain applications without foreign DNA integration may follow different regulatory pathways from conventional transgenic organisms.

This approach creates potential regulatory clarity for clustered regularly interspaced short palindromic repeats (CRISPR) and other gene editing applications, particularly in agricultural contexts. While still evolving, these frameworks signal Mexico’s recognition of the need for innovation-appropriate regulatory models for rapidly advancing technologies.

Also, COFEPRIS takes a more flexible approach for certain stem cell-based products and therapies. This flexibility enables companies to bring their treatments to market faster, meeting patient needs without the prolonged delays and high costs associated with cell therapy approvals.

By leveraging Mexico’s more lenient regulatory landscape, companies can significantly reduce development timelines and costs, providing them with a competitive advantage and the ability to respond to market demands more efficiently.

Digital health and telemedicine frameworks

The Covid-19 pandemic catalysed Mexico’s development of comprehensive regulatory frameworks for digital health and telemedicine, transforming what was previously a regulatory gap into an emerging structured ecosystem.

One of the most significant regulatory advances was the 2021 update to NOM-241-SSA1-2012, which governs good manufacturing practices for medical devices. This revision formally introduced the concept of software as a medical device (SaMD), establishing clearer guidelines for digital tools designed for diagnostics, therapy and monitoring.

The publication of supplement 5.0 of the United Mexican States Pharmacopoeia for Medical Devices in May 2023 further demonstrates Mexico’s commitment to innovation. This supplement introduced a detailed framework for classifying and regulating medical software based on the risk levels posed, providing developers with unprecedented clarity. Notably, it established distinct pathways for systems, recognising their unique position at the intersection of artificial intelligence and healthcare delivery.

By incorporating standards for design, validation, manufacturing and quality control, Mexico has created a foundation that both ensures compliance and encourages innovation by reducing regulatory uncertainty for technology developers and investors.

In addition to these regulatory milestones, COFEPRIS and other Mexican regulatory bodies are actively exploring mechanisms to evaluate advanced technology, with particular emphasis on algorithm performance, bias mitigation and transparency requirements for clinical decision support (CDS) systems. The regulatory approach balances rigorous evaluation with practical considerations about implementation, specifically addressing how these systems integrate with existing clinical workflows and healthcare infrastructure. Regulators have also developed frameworks for protecting patient data, while enabling technological advancement, recognising that data governance is central to responsible digital health innovation.

By addressing these factors comprehensively, Mexico aims to build a robust ecosystem, in which cutting-edge technologies can thrive, while maintaining patient safety as the primary concern. The emerging regulatory landscape positions Mexico as an increasingly attractive market for digital health innovations, including sophisticated CDS systems that can help address healthcare access challenges.

Emerging regulatory initiatives

Several planned regulatory initiatives will likely shape Mexico’s life sciences innovation landscape in the coming years. COFEPRIS’s strategic plan identifies further digital transformation, international coordination and specialised innovation pathways as priorities for continued modernisation.

The proposed integration of artificial intelligence tools for regulatory decision support aims to enhance consistency and efficiency, particularly for standard product reviews. This initiative builds on international precedents, while addressing Mexico’s specific resource constraints and regulatory volumes.

Conclusion

Mexico’s life sciences regulatory landscape is experiencing a transformation that creates opportunities for innovation, while maintaining appropriate protections for public health and environmental safety through international engagement, digital modernisation and the adoption of risk-based approaches.

The developments across food, biotechnology and pharmaceutical sectors demonstrate a more coordinated effort to address historical barriers to innovation. As these reforms continue to evolve, Mexico is positioning itself not merely as a recipient of international approaches, but increasingly as an active participant in shaping the future of life sciences regulation across the Americas and beyond.

For global life sciences companies, these developments create new opportunities for market entry and expansion in Mexico, while potentially establishing models that could influence regulatory approaches throughout Latin America. By recognising and engaging with these evolving frameworks, innovators can more effectively navigate Mexico’s regulatory landscape and contribute to the country’s growing life sciences ecosystem.