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2 min read
On October 1, 2025, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published the Guidance on Requirements and Criteria for Orphan Drug Recognition, which standardizes the regulatory process under the Common Technical Document (CTD) format.
This milestone strengthens Mexico’s regulatory harmonization with international standards and reinforces the country’s commitment to expanding access to innovative therapies for rare diseases.
Although technical in nature, the document goes far beyond formal compliance — it redefines how pharmaceutical companies should structure dossiers, manage evidence, and anticipate regulatory evaluations in an environment that demands greater efficiency and transparency.
Key Aspects of the New Guidance
- Full CTD Structure (Modules 1 to 5): dossiers must follow the internationally recognized format, including administrative, quality (CMC), pre-clinical, and clinical information, as applicable.
- Definition of Orphan Drug: confirms the prevalence threshold of ≤ 5 persons per 10,000 inhabitants, aligned with global standards.
- Eligibility Criteria: applicants must demonstrate low prevalence, lack of adequate therapeutic alternatives, and potential benefit for the affected population.
- Recognition and Modifications: describes how to submit new or updated applications, ensuring traceability, consistency, and transparency.
- Harmonization and Reliance: the CTD structure facilitates the use of studies or assessments from reference authorities, supporting regulatory reliance and faster decision-making in Mexico.
What It Means for Pharmaceutical Companies
The impact of this guidance is both operational and strategic.
Operationally, companies must ensure the technical coherence of their documentation so that each CTD module accurately reflects product quality, safety, and efficacy.
From a strategic standpoint, this shift moves Mexico closer to an international convergence model, offering competitive advantages to organizations with regional or global operations.
By adopting a unified structure, companies can reuse data, shorten timelines, and strengthen documentation consistency across markets.
The transition, however, poses challenges: aligning operations and dossiers with the CTD framework without compromising agility.
This requires assessing system maturity, enhancing data traceability, and building teams capable of proactively responding to COFEPRIS requests.
In a landscape where technical information becomes a competitive asset, organizations that act early and adopt an integrated regulatory strategy will be better positioned to achieve compliance, predictability, and efficiency.
Freyr, with global expertise in regulatory intelligence, CTD compilation, and lifecycle management, supports companies in interpreting evolving regulations with strategic foresight and building stronger engagement with health authorities.
Next Steps for the Industry
- Review internal documentation systems to ensure future dossiers can be structured under the CTD format.
- Identify candidate products for orphan-drug recognition and validate prevalence and therapeutic-need data.
- Update pharmacovigilance and post-marketing plans in line with the new COFEPRIS criteria.
- Strengthen regulatory strategies with expert guidance to ensure proper implementation and portfolio optimization.
Final Reflection
The new COFEPRIS guidance represents more than a technical adjustment — it’s a call for regulatory maturity and international convergence.
Companies that adapt quickly will not only comply with new standards but also gain agility, predictability, and credibility before the authority.
With a solid strategy and comprehensive understanding of the CTD framework, this change becomes an opportunity to elevate Mexico’s regulatory landscape and reinforce regional competitiveness.
Contact Freyr to discover how our regulatory intelligence and CTD expertise help pharmaceutical organizations achieve efficiency, compliance, and sustained market access in Mexico and LATAM.
