Mexico Announces Landmark Agreement to Streamline Clinical Research Protocol Approvals for Foreign-Authorized Studies
March 24, 2025. Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has established groundbreaking new criteria for authorizing clinical research protocols that have already received approval from select foreign regulatory authorities. This significant regulatory development, published on March 18, 2025, will dramatically expedite the approval process for qualifying clinical trials in Mexico through a regulatory reliance pathway. The agreement represents a significant advancement in Mexico's clinical research landscape, potentially reducing approval timelines to 45 calendar days for eligible Phase III trials, positioning Mexico as an increasingly attractive destination for international clinical research while maintaining rigorous oversight of research safety and ethics.
Key Features of the COFEPRIS Agreement
The new agreement establishes a formal "Reliance" regulatory pathway, allowing COFEPRIS to consider and give significant weight to evaluations conducted by trusted foreign regulatory authorities when making authorization decisions for clinical research protocols1. Under this framework, COFEPRIS will recognize authorizations issued by four major global regulatory bodies:
European Medicines Agency (EMA) - for centralized process medicines
U.S. Food and Drug Administration (FDA)
UK's Medicines and Healthcare products Regulatory Agency (MHRA)
Health Canada1
This landmark regulatory shift reflects a growing international trend toward regulatory harmonization and resource optimization through trusted regulatory pathways. By implementing this reliance practice, COFEPRIS can focus its resources on protocols requiring full review while accelerating approvals for studies that have already undergone rigorous assessment by recognized authorities.
Eligibility Requirements and Scope
The reliance pathway is limited to Phase III clinical trials with non-adaptive designs and excludes master protocols. Eligible therapeutic areas include oncology, endocrinology, cardiology, rheumatology, allergy, neurology, dermatology, pneumology, gastroenterology, hematology, ophthalmology, and nephrology. Additionally, studies addressing high-impact pathologies in Mexico, such as diabetes mellitus, hypertension, lung cancer, melanoma, colon cancer, and B-cell lymphomhoma, may qualify for this expedited approval process.
Notably, the agreement stipulates that only active trials with investigational products without special alerts or warnings by other regulatory authorities or WHO will be eligible. Products withdrawn from any market for safety, efficacy, or quality concerns are excluded from this pathway1.
Digital Submission Requirements
Applications must be submitted exclusively through COFEPRIS's digital platform, DIGIPRiS, and must include:
A certified, legalized or apostilled copy of the foreign regulatory authority's authorization (with Spanish translation)
The protocol and investigator's manual in both English and Spanish
All standard documentation required for research protocol authorization in Mexico1
The digital-only submission requirement aligns with Mexico's broader efforts to modernize its regulatory processes and eliminate paper-based procedures.
Timeline and Implementation
COFEPRIS has committed to processing applications submitted through this reliance pathway within 45 calendar days, a significant improvement compared to traditional approval timelines. The agreement is scheduled to enter into force 60 business days after its publication in Mexico's Official Gazette of the Federation1 on March 18, 2025.
"This regulatory advancement positions Mexico as an increasingly attractive destination for multinational clinical trials," said Julio G. Martinez-Clark, CEO of bioaccess®. "By establishing this reliance pathway, COFEPRIS demonstrates its commitment to regulatory modernization while maintaining appropriate safeguards. This agreement will create new opportunities for medical innovation in Mexico while accelerating patient access to novel therapies."
Industry Impact and Clinical Research Landscape
The new reliance pathway comes amid growing interest in Latin America's clinical research environment. Recent regional developments include AtaCor Medical's groundbreaking extravascular ICD study in Paraguay2, Care Access's expansion in Brazil through the acquisition of CEMEC2, and CereVasc's innovative clinical trial in Argentina2.
This regulatory innovation by COFEPRIS may further amplify Mexico's competitiveness in the global clinical research arena, potentially attracting additional investment from international sponsors seeking efficient regulatory pathways while maintaining high patient protection standards.
Despite implementing this reliance pathway, COFEPRIS maintains its authority to request additional information, implement safety measures, or suspend studies when necessary to protect research subjects1. The commission emphasizes that final decisions remain the sole responsibility of COFEPRIS and are not directly linked to the conditions approved by foreign regulatory authorities1.
About bioaccess®
bioaccess® is the leading LATAM MEDTECH CRO specializing in regulatory affairs and clinical research services for medical device, diagnostic, and digital health companies seeking market approval, reimbursement, and clinical validation in Latin America. With extensive experience in regulatory strategy, clinical trial management, and market access, bioaccess® helps innovative medical technology companies navigate Latin America's complex regulatory environments. We aim to accelerate patient access to advanced medical technologies throughout the region.
