Mexico represents one of the most strategic pharmaceutical markets in LATAM, with a well-defined regulatory framework led by COFEPRIS (Federal Commission for the Protection against Sanitary Risks).

Understanding the medicinal product registration and approval process is essential for companies aiming to enter or expand in the Mexican market. While the framework is structured, requirements and timelines may vary depending on the product type, regulatory pathway, and dossier quality.

Below are 13 frequently asked questions that provide an overview of the current regulatory landscape for medicinal products in Mexico.

1. What is COFEPRIS, and what role does it play in Mexico’s medicinal product approval process?

   The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), or the Federal Commission for the Protection against Sanitary Risks, is the central authority in Mexico that is responsible for regulating health products, including drugs, medical devices, and food. COFEPRIS oversees the entire drug approval process in Mexico, from the initial application to the Post-market Surveillance (PMS) stage.

2. What types of medicinal products are subject to registration in Mexico?

   Medicinal products intended to be marketed in Mexico must be registered with COFEPRIS. This includes chemical drugs, biological and biotechnological products, as well as generic medicines and vaccines.

3. What are the different pathways for medicinal product registration in Mexico?

   In Mexico, medicinal products may be registered through different regulatory pathways depending on the product type and available supporting data. These may include:

4. Standard registration pathway
   • New molecular entities
   • Generic medicines
   • Biotechnological or biosimilar products
5. Equivalence or recognition-based pathways
   • Products approved by reference regulatory authorities (EU, Switzerland, USA, Canada, Australia) under established agreements.
   • Special regulatory pathways (when applicable)
   • Orphan drugs
   • Emergency use authorizations
   • Exceptional importation mechanisms 

6. What are the key steps involved in Mexico’s medicinal product registration process?

   The drug approval process in Mexico generally involves the following key steps:

   • Identification of the product type and applicable regulatory pathway
   • Preparation of the marketing authorization application (MAA) and supporting dossier
   • Submission through the appropriate regulatory channel (e.g., digital platforms such as DIGIPRIS or other applicable submission mechanisms).
   • Scientific and technical evaluation by COFEPRIS
   • Requests for additional information, if applicable
   • Approval and granting of marketing authorization

   For certain products, such as new molecular entities, evaluation by the New Molecules Committee (CMN) may be required.

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