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Any market entry strategy into Mexico begins with a regulatory prerequisite: obtaining drug marketing authorization. Whether you're looking to manufacture, import, or distribute pharmaceutical products, this requirement is essential for operating in compliance with local regulations.
This process, overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), involves a rigorous technical and legal evaluation. The authority has implemented digital tools and specific procedures to facilitate application submissions while maintaining strict standards for quality, safety, and efficacy.
Regulatory Classification and Approval Pathways
COFEPRIS classifies medicinal products into various categories, such as:
- Innovative drugs
- Generic drugs
- Biotechnological or biological products
- Herbal remedies
- Homeopathic medicines
Each product type determines the complexity of the procedure and the scope of documentation required.
Mexico is also a member of the Pan American Network for Drug Regulatory Harmonization (PANDRH) and has adopted elements from ICH and PAHO guidelines, particularly regarding Good Manufacturing Practices (GMP) and clinical studies.
Components of the Registration Dossier
The technical dossier typically follows the Common Technical Document (CTD) format and includes:
Module 3 – Quality: Detailed information on the active pharmaceutical ingredient (API), manufacturing process, quality control measures, product specifications, and stability studies in accordance with ICH guidelines.
Module 4 – Non-clinical studies: Preclinical data in animals (pharmacology, toxicology, pharmacokinetics), required for new molecules.
Module 5 – Clinical studies: Human clinical trials to demonstrate safety and efficacy. For generic drugs, bioequivalence studies are mandatory. COFEPRIS may accept international studies if they follow Good Clinical Practices (GCP) and are relevant to the Mexican population.
Administrative documents:
- Official application forms
- Proof of payment of regulatory fees
- Power of attorney for the legal representative
- GMP certificate (issued by a recognized authority)
- Certificate of Pharmaceutical Product (CPP) for imported products
Labeling and packaging:
Must comply with COFEPRIS guidelines and include mandatory information in Spanish, such as drug name, dosage, warnings, expiration date, and storage instructions.
Digital Submission via DIGIPRiS
Applications must be submitted through DIGIPRiS, COFEPRIS’s official digital platform for regulatory procedures. This tool, implemented to streamline processes, enables:
- Secure upload of technical and legal documents
- Electronic payment of fees
- Real-time tracking of application status and response to regulatory requirements
Foreign companies must appoint a legally established representative in Mexico to access and submit through DIGIPRiS. COFEPRIS also offers expedited recognition pathways for products previously approved by authorities such as the FDA, EMA, or Health Canada.
Evaluation and Issuance of the Marketing Authorization
Once submitted, COFEPRIS conducts a detailed technical review. In some cases, external expert committees may be consulted.
Timelines vary depending on the type of product and regulatory pathway applied. On average, evaluations take between 120 and 240 business days.
If successful, a five-year renewable marketing authorization is granted.
Post-Approval Obligations
Any post-approval changes — such as manufacturing site updates, reformulations, or label modifications — must be pre-approved by COFEPRIS.
Additionally, the agency oversees post-marketing pharmacovigilance, monitoring the safety and efficacy of products already on the market.
How Can Freyr Support You in Mexico?
At Freyr Solutions, we support pharmaceutical and life sciences companies throughout their market entry and expansion in Mexico, ensuring compliance from the very beginning.
Our local team specializes in regulatory affairs and offers:
- CTD dossier design and preparation for COFEPRIS
- Technical consulting for drug registration and international recognition pathways
- Strategic review of documentation for new applications or amendments
- Legal representation before COFEPRIS for foreign companies
- Full guidance in using and managing the DIGIPRiS platform
Our approach combines global experience with local regulatory insight, allowing clients to navigate the approval process confidently and efficiently.
Ready to take your regulatory strategy to the next level?
Contact our experts and chart a clear path toward successfully approving your products in Mexico.
