2 min read

Spanish

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has announced new regulatory simplification measures that will transform how pharmaceutical marketing authorizations are processed and maintained in Mexico. These actions aim to strengthen institutional efficiency through digital process modernization, the consolidation of a one-stop regulatory window, and the reduction of technical review timelines.

 The goal is clear: to build a more agile, transparent, and predictable COFEPRIS — one capable of responding to the dynamics of the pharmaceutical industry while ensuring continuous access to essential medicines in the country.

These actions form part of a broader COFEPRIS regulatory simplification strategy, focused on digital modernization and strengthening institutional trust.

Key Simplification Measures

  • Digitalization of Procedures 
    Implementation of the DIGIPRiS platform, which integrates online submission, tracking, and resolution of regulatory applications. This shift represents a deep step toward administrative modernization and the transition to a fully digital, paper-free COFEPRIS.
  • Reduced Review Timelines 
    Shorter evaluation periods for drug applications and technical assessments, particularly for essential medicines.
  • Streamlined Administrative Requirements
    Updated forms, removal of redundant documents, and expanded use of electronic signatures.
  • Traceability and Transparency
    Real-time tracking of dossier status and direct communication channels with evaluators.

Impact for the Pharmaceutical Industry

For companies with active or upcoming submissions, these measures require an operational reconfiguration.


Digitalization demands greater documentation consistency, stronger technical response capability, and a more robust internal alignment across Regulatory Affairs, Quality, and Pharmacovigilance functions.

The benefits are clear:

  • reduced administrative burden,
  • more predictable timelines,
  • and incremental alignment with internationalregulatory reliance 

However, the transition requires investment in training, digital infrastructure, and operational risk management.

In an environment where verified digital information becomes a strategic asset, organizations that anticipate and adapt their internal systems will be the best positioned to leverage the efficiencies of this new COFEPRIS framework.

Strategic Tips and Recommended Actions

  • Audit internal processes and verify the compatibility of current systems with COFEPRIS’ digital platforms.
  • Update user profiles and access permissions in DIGIPRiS to ensure full traceability, control, and security.
  • Implement electronic-signature controls and document-validation workflows.
  • Strengthen coordination between regulatory and quality teams to meet the new response timelines.
  • Consider expert support to optimize regulatory operations and post-approval maintenance.

Final Insight

Regulatory simplification does not imply less rigor — it reflects a shift toward institutional maturity, efficiency, and digital evolution. Mexico is taking a decisive step toward regulatory modernization, and companies that adapt quickly will gain greater agility, predictability, and competitiveness in their operations.

With a solid regulatory strategy and support from experts in regulatory intelligence and COFEPRIS digitalization, organizations can move from basic compliance to operational excellence.

At Freyr, we help pharmaceutical companies plan and execute regulatory strategies that ensure compliance, efficiency, and sustained market access.


Need to optimize your regulatory strategy in Mexico or LATAM?Contact us