Overview
On 2025, the Mexican Federal Commission for Protection against Sanitary Risks (COFEPRIS) published a new regulatory framework in the Diario Oficial de la Federación (DOF) establishing an abbreviated regulatory pathway for sanitary licenses of health products. This mechanism is grounded in the concept of regulatory reliance, whereby COFEPRIS recognizes the evaluation outcomes of trusted foreign regulatory authorities (Reference Regulatory Authorities – RRAs) as the basis for its own approval decisions.
Introduction
The primary goal of this pathway is to streamline and speed up the registration process for medicines and medical devices without compromising safety, quality, or efficacy, ultimately promoting more efficient access to innovative health technologies in Mexico. Under the new guidelines, COFEPRIS must issue decisions within 45 business days for medicines and 30 business days for medical devices, significantly reducing traditional review timelines.
This blog examines the key features of the abbreviated pathway, its practical implications, and why this represents a major step forward in Mexico’s regulatory modernization.
What is the Abbreviated Regulatory Pathway (“Reliance”)?
The abbreviated regulatory pathway introduced by COFEPRIS allows regulatory submissions for medicines and medical devices to leverage assessments previously completed by other high-performing regulatory authorities. Instead of repeating full evaluations, COFEPRIS can consider foreign approvals as equivalent — provided the product submitted for registration in Mexico is identical to the one authorized abroad and the reference approval was issued within the last five years.
This reliance approach aligns with Good Regulatory Practices (GRP) and is supported by international standards, including guidance from the World Health Organization (WHO).
Recognized Reference Regulatory Authorities (RRAs) under this mechanism may include:
- Medicines: FDA (United States), EMA (European Union), WHO-listed authorities and ICH founders
- Medical Devices: Agencies participating in the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP)
Scope and Eligibility
The abbreviated pathway applies broadly to a range of health products, including but not limited to:
- Medicines: new chemical entities, generics, biosimilars, vaccines, biologics
- Medical Devices: equipment, diagnostic tools, implants, prosthetics
For eligibility:
- The product must be essentially identical (same formulation, intended use, manufacturing process, performance) to the version approved by an RRA.
- The foreign authorization must be current (issued within five years prior to submission).
- Complete legal and technical documentation must accompany the application.
Importantly, COFEPRIS retains its technical and operational autonomy, assessing whether the foreign assessment genuinely complies with Mexican regulatory standards.
Accelerated Review Timelines
The new framework establishes mandatory maximum review periods to enhance predictability for applicants:
- Medicines: up to 45 business days
- Medical Devices: up to 30 business days
These timelines start once COFEPRIS receives a complete dossier that fulfills all specified requirements. By imposing clear deadlines, the abbreviated pathway significantly shortens the time to market compared to traditional registration routes.
Benefits and Strategic Importance
The introduction of this abbreviated pathway offers several benefits:
- Greater regulatory efficiency: Reduces duplication of assessments previously carried out by trusted agencies.
- Faster access to health technologies: Patients and healthcare providers gain quicker access to safe and effective products.
- Global regulatory alignment: Encourages harmonization with international standards and adoption of best practices.
- Increased market predictability: Defined review timelines provide clear expectations for industry planning.
The reliance approach also complements bilateral and multilateral regulatory cooperation initiatives — such as agreements recognizing ANVISA and COFEPRIS as reference authorities — strengthening scientific collaboration between Mexico, Brazil, and other regulatory systems.
Conclusion
COFEPRIS’s introduction of an abbreviated regulatory pathway based on reliance represents a transformative advancement in Mexico’s sanitary regulatory framework. By recognizing the decisions of international reference authorities and setting clear review timelines (45 days for medicines and 30 days for devices), Mexico has aligned its regulatory environment more closely with global best practices while maintaining rigorous standards for quality, safety, and efficacy.
For manufacturers and regulatory professionals, this pathway offers a strategic opportunity to accelerate product entry into the Mexican market — fostering innovation, enhancing competitive positioning, and ultimately improving public health outcomes.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
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References
Learn more about.
- COFEPRIS publishes the general guidelines for the abbreviated regulatory pathway in the Diario Oficial de la Federación (July 18, 2025).
- Mexico expands health product registration process with new guidelines (abbreviated pathway details).
- Mexico opens an abbreviated pathway for health products (timelines and reliance concept).
- COFEPRIS enables regulatory reliance through an abbreviated pathway (eligibility and requirements).
- Latin America roundup: Mexico formalizes regulatory equivalence agreements.
- Brazil and Mexico strengthen regulatory cooperation with reliance mechanisms.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.
