The drug approval process in Mexico ensures that pharmaceutical products meet the necessary standards for safety, efficacy, and quality before they can be marketed. This process, regulated by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), involves several critical steps.

1. Submission of Application 

Pharmaceutical companies must submit a comprehensive dossier to COFEPRIS, including technical and scientific information that demonstrates the drug's stability, efficacy, and safety.

2. Technical Information Requirements 

The dossier should include essential data such as:

• Preclinical and clinical study reports
• Pharmacovigilance plans
• Manufacturing process details
• A certificate of Good Manufacturing Practices (GMP) from the country of origin or from COFEPRIS if the drug is manufactured outside Mexico
• The information in the dossier to COFEPRIS is submitted according to the CTD (Common Technical Document) format.

3. Patent Documentation 

If applicable, applicants must provide proof of patent ownership for the substance or active ingredient, or a corresponding license. These documents must be registered with the Mexican Institute of Industrial Property (IMPI).

4. New Molecules Committee Evaluation 

For new molecules, a technical meeting with the New Molecules Committee is required before submitting the application for sanitary registration. The committee assesses analytical, preclinical, and clinical studies to determine if they meet the necessary Regulatory requirements.

5. Labeling and Packaging Compliance 

Draft labels and instructions for both primary and secondary packaging must align with the corresponding Official Mexican Standard to ensure proper consumer information and safety. The label or back label must be presented in Spanish.

6. COFEPRIS Review Process 

COFEPRIS conducts a thorough review of the application and all supporting documents. The review timeline depends on the type of drug:

• Drugs with active ingredients already registered in Mexico: Maximum review period of 180 calendar days.
• Drugs with new molecules: Maximum review period of 240 calendar days.

Note: The periods of review of the information by the health authority may vary according to the current workload of COFEPRIS.

7. Approval and Registration 

If all requirements and standards are met, COFEPRIS issues a marketing authorization (sanitary registration), allowing the drug to be legally marketed and distributed in Mexico.

8. Post-Marketing Surveillance 

Once a drug is approved, the holder of the sanitary registration must conduct pharmacovigilance activities to monitor its safety and effectiveness in the market. This ongoing surveillance helps detect and mitigate potential adverse effects.

Understanding and navigating Mexico’s Regulatory framework is essential for pharmaceutical companies looking to enter this market. By ensuring compliance with COFEPRIS guidelines and leveraging available expedited pathways, companies can streamline the approval process and bring essential medicines to patients more efficiently.

Looking for a trusted regulatory partner to navigate Mexico’s complex regulatory landscape? Freyr Solutions is here to help.

With extensive expertise in regulatory affairs, Freyr provides end-to-end support across product development, registration, and commercialization. Our team of experts is well-versed in Mexico’s regulatory requirements, ensuring a streamlined and efficient approval process for your pharmaceutical products. Partner with Freyr to accelerate your drug’s development and market entry with confidence.