The second half of 2026 has seen particularly active participation in the forums shaping Mexico’s healthcare sector. Organized by private-sector organizations, government institutions and civil society associations, these discussions have brought together the sector’s three fundamental pillars: industry, government and academia and research. Their efforts converge around a central question: what must Mexico do to sustain and expand its healthcare manufacturing ecosystem while ensuring that it can meet the needs of its population? This is not a rhetorical question. It is a strategic imperative.
Through initiatives such as Plan México, the country is seeking to strengthen its domestic capacity to manufacture medicines, vaccines, medical devices and other essential healthcare products. The relevance of this sector extends far beyond its economic contribution. It attracts high-value-added investment, supports skilled employment, encourages technological development and creates opportunities for innovation. Above all, however, it responds to a fundamental social need: ensuring reliable access to the products and technologies required to protect public health.
The changing epidemiological landscape further underscores this need. As health and business journalist Maribel Ramírez Coronel has recently highlighted, greater attention is being given to an integrated approach to cardiovascular-kidney-metabolic health, recognizing the close relationship among obesity, hypertension, diabetes, cardiovascular disease and chronic kidney disease. These conditions cannot be addressed effectively in isolation, as they often have been in the past. Their interconnected nature requires coordinated prevention, diagnosis and treatment strategies. It also creates an opportunity—and a responsibility—for the pharmaceutical and medical device industries to develop and manufacture integrated solutions that respond to Mexico’s evolving healthcare needs. To seize this opportunity, however, Mexico must address several structural barriers that continue to limit the sector’s ability to invest, innovate and expand at the required pace.
Uncertainty Surrounding the USMCA Review.
The 2026 review of the United States–Mexico–Canada Agreement (USMCA) has created uncertainty regarding the future commercial conditions governing the production and sale of medicines, active pharmaceutical ingredients (APIs), vaccines, medical devices and other healthcare products, whether generic or patented. This raises several important questions. Will medicines and healthcare products manufactured in Mexico retain competitive access to the United States and Canada without unnecessary tariff or non-tariff barriers? Will greater regulatory compatibility be achieved across the three countries? Or will geopolitical and industrial-policy pressures continue to encourage the relocation of a significant share of pharmaceutical manufacturing to the United States?
These questions are particularly relevant because the current review process has explicitly identified pharmaceuticals and medical devices as sectors in which greater regulatory cooperation could strengthen North American supply chains. For Mexico, the objective should not simply be to preserve market access. It should be to establish itself as a reliable, high-quality and strategically integrated manufacturing partner within North America. Achieving this will require regulatory convergence, stronger regional supply chains and clear rules that provide companies with the certainty needed to make long-term investments.
COFEPRIS Review and Response Times.
Another recurring challenge concerns the time required by the Federal Commission for Protection against Health Risks (COFEPRIS) to process regulatory submissions and authorizations. These procedures include, among others, marketing authorizations for new medicines and therapies; permits for importing raw materials and APIs; notifications and approvals related to manufacturing-process changes; authorizations for innovative and orphan products; submissions for new or improved medical devices; and the issuance of Good Manufacturing Practice certificates.
When regulatory timelines are prolonged or unpredictable, the consequences extend beyond administrative inconvenience. Delays can postpone product launches, interrupt manufacturing plans, increase inventory and financing costs, and ultimately restrict or delay patients’ access to essential therapies and technologies. Regulatory rigor is indispensable in the healthcare sector and should never be compromised. Nevertheless, rigor and efficiency are not mutually exclusive. A modern regulatory authority must protect public health while also providing transparent requirements, technically sound evaluations and predictable resolution times. Additional investment in regulatory capacity, specialized personnel, digital infrastructure, reliance mechanisms and risk-based review processes would allow COFEPRIS to become not only a supervisory authority, but also a strategic enabler of innovation and industrial development.
Financial Pressure Across the Healthcare Supply Chain.
A third critical barrier is the flow of payments between public institutions, manufacturers, distributors and suppliers. Approximately ten years ago, payment terms across much of the value chain were commonly set at 30 days. These periods gradually extended to 45 or 60 days, while companies participating in government procurement may now face payment cycles of 90 days or, in some cases, as long as 120 days. During this period, manufacturers must continue meeting all their operating commitments: payroll, facilities, machinery, utilities, raw materials, components, specialized services, quality systems and regulatory compliance, among many others. The resulting pressure is particularly severe for small and medium-sized domestic suppliers, which generally have less access to working capital and less capacity to absorb prolonged payment cycles.
Many companies are therefore compelled to rely on factoring arrangements or bank financing. Although these instruments provide liquidity, their cost reduces the resources available for investment, innovation, productivity improvements and price negotiations. Strengthening domestic production therefore requires more than procurement preferences. It also requires predictable payment practices, access to competitive financing and mechanisms that prevent smaller suppliers from effectively financing the healthcare system at their own expense. From Identifying Barriers to Implementing Solutions. Many additional challenges could be considered, including limited domestic API production, dependence on imported technologies, shortages of specialized talent, fragmented procurement planning and insufficient coordination among stakeholders. Taken together, these factors can become burdens rather than drivers of innovation, investment and growth in a sector that Plan México has specifically identified as strategic.
Supporting domestic suppliers consequently requires a coordinated industrial policy based on several priorities: Establishing predictable, transparent and science-based regulatory pathways. Defining and enforcing reasonable payment periods across public procurement. Expanding access to competitive financing for small and medium-sized healthcare suppliers. Encouraging technology transfer and the local production of APIs, components and critical materials. Strengthening technical education and specialized workforce development. Promoting regulatory compatibility and resilient supply chains across North America. Using public procurement strategically, with clear quality, compliance and domestic-value criteria. Supporting collaboration among manufacturers, universities, research centers, healthcare institutions and regulatory authorities.
Domestic-content requirements alone will not create a competitive industry.
Mexico must also ensure that domestic suppliers can meet international standards of quality, traceability, regulatory compliance, productivity and technological capability. Strategic Intelligence as an Industry Resource. Civil society organizations and industry associations have remained highly active in addressing these challenges. Meetings have taken place among industry representatives, the Senate of the Republic, COFEPRIS and other authorities to identify solutions to the issues currently limiting the sector’s development. A particularly relevant initiative is the recently established Unidad de Inteligencia Estratégica Farmacéutica (UIEF), or Pharmaceutical Strategic Intelligence Unit, created by the Mexican Association of Regulatory Affairs Professionals (AMEPRES México) in collaboration with Universidad de las Américas Puebla (UDLAP). The initiative is intended to integrate scientific, technological, regulatory, market and industrial information to anticipate trends, reduce uncertainty and strengthen decision-making throughout the pharmaceutical ecosystem. Its underlying premise is both timely and necessary: information must be transformed into knowledge, and knowledge into a competitive advantage. UIEF is expected to incorporate insights from multiple fields, including artificial intelligence and big data analytics.
These technologies are already transforming pharmaceutical research, manufacturing, pharmacovigilance, regulatory strategy and market analysis. Properly applied, they can significantly improve foresight, risk assessment and evidence-based decision-making. For an initiative of this nature to achieve its full potential, however, strategic intelligence must be accompanied by an environment in which decisions can be implemented. Better information cannot, by itself, compensate for regulatory uncertainty, financing constraints, delayed payments or insufficient industrial coordination. Reducing these barriers will allow the knowledge generated by UIEF and similar initiatives to translate into investment, innovation and measurable progress across the pharmaceutical and medical device sectors.
A Shared Responsibility.
The final consideration is perhaps the most important: strengthening Mexico’s domestic healthcare supply cannot be the responsibility of a single institution or sector. Industry must invest in quality, technology, talent and compliance. Government must provide regulatory certainty, effective institutions, predictable procurement and timely payments. Academia and research centers must help generate knowledge, specialized talent and solutions that respond to real industrial and public-health needs. These stakeholders must learn to work in a coordinated manner, listen to one another’s needs and participate actively in the development of comprehensive solutions. Collaboration among industry, government and academia and research is not merely desirable. It is a prerequisite for strengthening domestic suppliers, expanding manufacturing capacity and ensuring the quality, continuity and availability of the products that Mexico’s healthcare system and its population require.
Author: Deyanira Chiñas
Source: https://mexicobusiness.news/health/news/beyond-bottlenecks-strategic-future-mexico-healthcare
