Modernization of the COFEPRIS Regulatory Framework: Introduction of a Reliance Pathway
Diario Oficial de la Federación (DOF) published a new agreement in July 2025, a major change to Mexico’s regulatory framework proposed by COFEPRIS.
This created a new regulatory pathway known as the “reliance pathway,” this agreement allows COFEPRIS to accept certifications, assessments, and authorizations from the World Health Organization (WHO) and reference regulatory bodies. This reform brings Mexico’s regulatory system in compliance with international norms, which provides faster access to high-quality, safe, and efficient drug products and medical devices.
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Scope of the COFEPRIS Reliance Pathway Agreement
The reliance mechanism allows COFEPRIS to consider as equivalent the requirements, tests, and evaluations previously issued by recognized authorities, thereby reducing duplication of regulatory assessments.
Products eligible under this pathway include-
- New molecules
- Generic medicines
- Biotechnological innovations
- Biosimilars
- Biological products and vaccines
- Medical devices
Also Read: COFEPRIS Notice of Operation requirement
Application of COFEPRIS Reliance Pathway to Medicines
COFEPRIS will recognize evaluations issued by:
- Reference Regulatory Authorities (RRA): Countries that are founding members and permanent participants of the International Council for Harmonisation (ICH).
- WHO-Listed Authorities (WLA): Regulatory agencies designated under the WHO framework.
This recognition will streamline the evaluation process and accelerate the availability of medicines in Mexico.
Application of COFEPRIS Reliance Pathway to Medical Devices
For medical devices, COFEPRIS will accept:
- Decisions from member countries of the Management Committee of the International Medical Device Regulators Forum (IMDRF).
- Certificates of Good Manufacturing Practices issued by full members of the Medical Device Single Audit Program (MDSAP).
This reliance mechanism aims to support faster regulatory review and strengthen patient access to innovative medical technologies.
Impact of the update on Mexico’s Market
- Regulatory convergence: This brings Mexico’s regulatory system in line with global best regulatory practices.
- Good Regulatory Practices: Supports WHO-promoted ideas of depending on reliable regulatory bodies.
- Efficiency and transparency: Shortens market entry timelines, enhances submission resources utilization, and minimizes redundant evaluations.
- Benefit to public health: Provides better accessibility of safe, efficient, and high-quality medical items.
Final Thoughts
This agreement puts Mexico’s medical device regulations on path to higher optimization. This would provide actual improvement in submission efficiency along with approval timelines which would support more wider global manufacturers.
Artixio’s Mexico team equipped to provide focused regulatory intelligence and submission support for optimized and timely medtech registrations to its global clients.
