## [Freyr 3D Series · Orphan Drugs: A Strategic Look at Mexico, Brazil, and Colombia Part 1 · Mexico – Incentives, Requirements, and Challenges](/blog/freyr-3d-series-orphan-drugs-a-strategic-look-at-mexico-brazil-and-colombia-part-1-mexico-incentives-requirements-and-challenges) October 14, 2025 ![Freyr 3D Series · Orphan Drugs: A Strategic Look at Mexico, Brazil, and Colombia Part 1 · Mexico – Incentives, Requirements, and Challenges]() 3 min read - [Medicinal Products](/blog-main-categories/medicinal-products) - [Regulatory Affairs](/blog-main-categories/regulatory-affairs) [Spanish](/blog/freyr-3d-series-medicamentos-huerfanos-en-america-latina-una-mirada-estrategica-a-mexico-brasil-y-colombia-parte-1-mexico-incentivos-requisitos-y-desafios) In this three-part series, we explore how **Mexico, Brazil, and Colombia** have built their own regulatory frameworks for orphan drugs, each with particular features that, together, provide a representative overview of some Latin American countries. The first entry of the **Freyr 3D Series on orphan drugs in LATAM** examines **Mexico’s regulatory framework**. Upcoming articles will address **Brazil and Colombia**, providing an integrated perspective of key countries in the region. In **Mexico**, orphan drug regulation is inspired by international standards, particularly those of the **FDA** and the **EMA**, and is consolidated through **COFEPRIS rare diseases** as the health authority. A drug is classified as an orphan when it affects fewer than **5 individuals per 10,000 inhabitants**, according to the criteria established for **sanitary registration in Mexico** ## About Rare Diseases and Orphan Drugs **Rare diseases**, although infrequent, represent a major challenge for healthcare systems and a unique opportunity for the pharmaceutical industry. **Orphan drugs in Mexico** —those intended to treat conditions affecting very small populations— are a bridge between innovation, social impact, and sustainability. ## Regulatory Framework - **Formal recognition of orphan drugs in Mexico** through the **General Health Law** (Articles 224 Bis and 224 Bis 1, reformed in 2012), which incorporated this figure into Mexican legislation for the first time. - **COFEPRIS’s rare diseases** guidelines, which operationalize these articles through technical criteria: prevalence definition (**fewer than 5 cases per 10,000 inhabitants**), dossier requirements, and **Mexico’s pharmacovigilance** provisions. - References to international standards, such as the **FDA** and **EMA**, allow for harmonization and **FDA EMA reliance** on external certifications. The **Mexican regulatory framework** is relatively young and less developed than that of other countries in the region. However, it is clearly aligned with international benchmarks such as the **FDA** and the **EMA**. This alignment grants legitimacy and enables **Mexico** to join the global movement toward differentiated access. Still, the country lacks solid financial mechanisms to ensure sustainable long-term access. Moreover, formal recognition does not always translate into effective availability for patients, as decisions regarding **pricing, reimbursement, and coverage** remain limited and subject to negotiation. Consequently, while the legal structure opens the door to innovation, actual access depends on **economic, political, and funding factors** that remain unresolved challenges. ## Incentives and Benefits - **Differentiated evaluation processes** that allow reduced documentation requirements in certain cases. - pathways for critical needs that help shorten **COFEPRIS** response times for priority therapies. - on foreign certifications (**CPP, GMP**), which facilitates acceptance of international evidence to streamline dossiers. Recently, **COFEPRIS** reported on its website the recognition of nearly one hundred orphan drugs, reflecting the growing interest of the industry. ## Technical Requirements - Submission of a **dossier in CTD format**, with information on **quality, safety, and efficacy**. - Inclusion of sufficient **clinical and preclinical evidence**, adapted to the target population. - Establishment of a **pharmacovigilance unit in Mexico**, essential for **post-marketing monitoring**. Although there are clear incentives, the technical requirements of **COFEPRIS for rare diseases** are rigorous. The real challenge for companies lies in **translating international evidence into the local context**, which requires investment in **certified translations**, **formal adaptations**, and harmonized documentation processes for **sanitary registration in Mexico.** ## Challenges - **High costs** for **small populations** put pressure on the **economic viability** of therapies. - **Limited clinical evidence** makes it difficult to build strong regulatory dossiers. - **Accessibility and reimbursement challenges**, with significant pressures due to **high prices** that impact both **patients** and **healthcare systems**. ## Role of a Strategic Partner In **Mexico**, where regulation prioritizes **speed of evaluation** and **international reliance**, the challenge for companies is not only to prepare a solid dossier but also to **adapt global evidence to the Mexican regulatory framework** and meet the requirements of **COFEPRIS rare diseases**. **Freyr LATAM** supports organizations in turning that speed into tangible results: harmonizing dossiers, ensuring the quality of certified translations, and anticipating local requirements so that access becomes faster, safer, and more sustainable.  **Explore how your company can transform regulatory complexity into a clear path toward access in Mexico.** [Let’s discuss how to anticipate your strategy together.](https://qr.pro/i/p/684c71ec3a7b5)