,
3 min read
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.
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.
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.
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:
- Standard registration pathway
- New molecular entities
- Generic medicines
- Biotechnological or biosimilar products
- 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
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.
What are the Regulatory guidelines for clinical trials in Mexico?
Clinical trials must be conducted in accordance with applicable Mexican regulations and international standards (e.g., ICH-GCP). Applicants must submit a Clinical Trial Application (CTA) to COFEPRIS for approval before initiating the trial.
Clinical research must also comply with relevant legal frameworks and institutional requirements, including ethics and regulatory approvals, as applicable.
What are the challenges of navigating the medicinal product Regulatory landscape in Mexico?
Some of the key challenges associated with navigating the medicinal product regulatory landscape in Mexico include:
- Complex and evolving regulatory requirements
- Limited availability of publicly accessible guidance
- Variable approval timelines depending on the regulatory pathway
What is the first step toward getting your medicinal product approved?
The first step is to identify the type of medicinal product (e.g., chemical, biological, or biotechnological), as this classification defines the regulatory requirements, data expectations, and submission pathway before COFEPRIS.
What documents do you need to submit to COFEPRIS for approval?
Applicants must submit a comprehensive dossier containing information on the product’s quality, safety, and efficacy, as well as manufacturing and administrative documentation, in accordance with the Common Technical Document (CTD) structure as per ICH and national regulatory requirements.
How long does the approval process take?
The timeline for COFEPRIS approval depends on factors such as the type of medicinal product, its classification, and the selected regulatory pathway.
While defined review processes exist, actual timelines may vary depending on the complexity of the evaluation, dossier quality, and authority workload. In addition to the standard review process, certain products may be eligible for alternative procedures—such as equivalence or reliance-based pathways—which may influence overall timelines.
What happens if COFEPRIS requests additional information?
If COFEPRIS requests additional information, applicants are required to respond within the specified timelines by addressing any queries or deficiencies identified during the evaluation process.
COFEPRIS provides formal communication and guidance to support the completion of the review.
Can I appeal a COFEPRIS decision?
Yes, applicants may request reconsideration or challenge a COFEPRIS decision through established administrative procedures. The applicable process will depend on the nature of the decision and must comply with Mexican regulatory requirements.
Does COFEPRIS offer any guidance or support to applicants?
Yes, COFEPRIS provides regulatory guidance, technical requirements, formats, and official documentation to support applicants throughout the submission and evaluation process.
- What are the post-approval requirements for your medicinal product?
After approval, marketing authorization holders must comply with ongoing regulatory obligations, including pharmacovigilance and safety reporting, implementation of labeling updates, and submission of variations or changes, as applicable.
Do not let Regulatory hurdles hold you back! Contact Freyr today and let our experts guide you toward a successful drug registration in Mexico.
