Mexico’s COFEPRIS Rolls Out Anti-Counterfeit Plan

Mexico is advancing a coordinated strategy to position itself as a regional leader in clinical research and medical innovation, as federal regulators, academic institutions and pharmaceutical executives align efforts to accelerate the path from laboratory discovery to patient access.

During the Tec Science Summit 2026, representatives from Tecnológico de Monterrey, industry stakeholders and regulatory authorities outlined structural reforms designed to reduce bottlenecks in the country’s research ecosystem. While Mexico has demonstrated scientific capacity at the laboratory level, panelists acknowledged that many projects fail to progress due to limited financing and procedural complexity.

Successful “molecule-to-human” transitions at institutions such as the National Polytechnic Institute (IPN) and Tecnológico de Monterrey were cited as proof of concept. Speakers emphasized that greater integration between academia, industry and regulators will be essential to scale these outcomes and enhance Mexico’s competitiveness in global clinical development.

Regulatory Modernization to Accelerate Approvals

Abraham Israel Villarreal Castellanos, coordinator of clinical trials, Federal Commission for Protection against Sanitary Risk (COFEPRIS), announced that the agency is finalizing a new regulatory evaluation model aimed at improving predictability and reducing approval timelines.

The reform is built on three pillars: standardized regulatory criteria, international regulatory cooperation and a transition toward risk-based supervision.

To address procedural inconsistencies, COFEPRIS is developing detailed technical guidelines intended to eliminate ambiguity in submission requirements. A key instrument within the framework is the “Reliance” mechanism, which allows the Mexican regulator to recognize prior assessments conducted by leading international agencies for Phase 3 clinical trials. By leveraging existing evaluations, the agency expects to shorten local review times while ensuring that approved therapies remain appropriate for Mexico’s epidemiological profile.

The regulator also intends to shift from a purely authorization-centered model to one emphasizing risk management and post-market oversight. Under this approach, complex and innovative therapies will receive priority scrutiny, while lower-risk products will move through more streamlined pathways.

Counterfeit Medicines: A Parallel Threat

The regulatory modernization effort is unfolding amid heightened concern over the proliferation of counterfeit medicines. The World Health Organization (WHO) estimates that falsified pharmaceuticals contribute to approximately 700,000 deaths globally each year.

Mexico ranks among the world’s largest markets for illegal medicines, with authorities estimating that up to 60% of products sold through informal channels are stolen, expired or falsified. Criminal organizations have expanded beyond non-essential medications to target treatments for oncology, diabetes and cardiovascular diseases—therapies where treatment interruption can be life-threatening.

Industry representatives warned that counterfeit products often contain incorrect dosages or harmful substances, undermining therapeutic efficacy and increasing public health risks. Companies including Bristol Myers Squibb and Colorcon highlighted the reputational, economic and safety consequences of supply-chain vulnerabilities.

Toward a More Competitive and Secure Ecosystem

COFEPRIS reiterated the importance of due diligence across the supply chain, urging consumers to verify packaging integrity, lot numbers and expiration dates, and to avoid purchasing medicines through unverified digital platforms. Globally, nearly 6,900 incidents of falsified medicines were reported in 2023.

Authorities expect to publish formal guidelines for the updated regulatory model in the coming days. By combining streamlined clinical evaluation processes with stronger surveillance and enforcement, Mexico aims to simultaneously improve innovation capacity and safeguard public health.

The broader objective, officials said, is to build a regulatory and industrial environment capable of attracting international clinical trials while ensuring that Mexican patients gain faster and safer access to cutting-edge therapies.