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In recent years, Latin American countries have advanced in adopting reliance mechanisms and international cooperation schemes to expedite the authorization of drugs and medical devices. These practices, promoted by the World Health Organization (WHO) and the Pan American Health Organization (PAHO) under the framework of Good Reliance Practices (GRP), aim to optimize regulatory resources by leveraging evaluations already conducted by other health authorities, particularly those belonging to IMDRF and MDSAP.

Brazil, through its regulatory agency ANVISA, participates in international networks such as PANDRH and IPRP, implementing work-sharing models that enable joint dossier reviews. Colombia has strengthened INVIMA by recognizing GMP and CPP certificates issued by reference authorities, accelerating market entry while maintaining quality standards.

In this context, Mexico has positioned itself as a strategic and dynamic market, with the pharmaceutical sector accounting for approximately 1.2% of the national GDP, according to CANIFARMA. Its role as a gateway to Latin America has been reinforced by the creation of the COFEPRIS Abbreviated Pathway, a mechanism designed to guarantee timely access to innovative and essential medicines.

What is the COFEPRIS Abbreviated Pathway?

The Abbreviated Pathway is a regulatory procedure that reduces authorization timelines to approximately 45 business days for medicines and 30 business days for medical devices, compared to the typical 90–120 days in traditional processes.

It is based on equivalence and recognition agreements with reference health authorities, including FDA, EMA, Health Canada, and Swissmedic, as well as multilateral entities: ICH, WLA, and WHO for medicines; and IMDRF and MDSAP for medical devices. This framework allows COFEPRIS to leverage prior international evaluations and make faster, more reliable regulatory decisions.

This model aligns with Good Reliance Practices and positions Mexico at the center of the global regulatory modernization trend.

Scope and Eligible Products

The Abbreviated Pathway applies to a broad range of products:

  • new molecules, generics, biologics, vaccines, and biotechnological products.
  • Medical devices: Classes I, II, and III.

Advantages for the Pharmaceutical Industry

  • Reduced review timelines: responses in approximately 45 business days for medicines and 30 business days for medical devices
  • Administrative and documentary simplification, avoiding duplication of studies.
  • Greater predictability in approval timelines.
  • Strengthened the competitiveness of Mexico by aligning with international regulatory practices.

Challenges and Technical Considerations

Although it is an accelerated route, technical requirements remain strict.

  • The product submitted through the Abbreviated Pathway must be exactly the same as the one registered with a reference authority — meaning identical brand name, generic name (same molecule), dosage, and formulation.
  • The authorization in the country of origin must be valid and granted through the ordinary route. Approvals issued under an abbreviated, simplified, or fast-track pathway in the reference country are not recognized by COFEPRIS.
  • Minimum documentation is still mandatory and must comply with COFEPRIS formats.
  • A local Pharmacovigilance Unit (PVU) is required.
  • Quality, labeling, and traceability modules must meet Mexican regulations.
  • Potential discrepancies between international approvals and local requirements may cause delays if not anticipated.

Connection with Global Trends

The Abbreviated Pathway of COFEPRIS is a tangible example of how Mexico applies Good Reliance Practices promoted by the WHO and PAHO.

  • Reinforces the logic of international cooperation.
  • Highlights that even in simplified schemes, pharmacovigilance and traceability remain mandatory.
  • Connects Mexico with the regional regulatory modernization movement, in which Brazil and Colombia are also advancing with reliance and fast-track mechanisms.

Preparation and the Role of a Strategic Partner

The success of the Abbreviated Pathway depends on thorough preparation, including:

  • Adapting international dossiers to local formats.
  • Conducting a gap analysis to anticipate regulatory discrepancies.
  • Ensuring legal representation and a PVU in Mexico.

Freyr LATAM combines global expertise in Medicinal Products with local presence, helping companies minimize risks, accelerate approvals, and ensure market continuity under the demands of the Abbreviated Pathway in Mexico — or any other regulatory challenge.

Strategic Outlook

The COFEPRIS Abbreviated Pathway is not just a technical mechanism, but a strategic tool that redefines access to the Mexican market. It represents a concrete opportunity to optimize time and resources, provided it is approached with adequate technical preparation and long-term vision.

Is your company considering the Abbreviated Pathway in Mexico? Schedule a session with our experts and discover how to structure your dossier to maximize this opportunity.