Pharmaceutical Product Registration in Mexico - Overview
The "Comisión Federal para la Protección Contra Riesgos Sanitarios" (COFEPRIS) is the key drug Regulatory Authority in Mexico. The drug department of the COFEPRIS is responsible for pharmaceutical product registration in Mexico and handling, licensing the manufacture, import, export, distribution, promotion, advertising, and pharmaceutical product registration in Mexico. The COFEPRIS is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
COFEPRIS drug approval is an essential step in pharmaceutical product registration in Mexico, as it ensures compliance with Mexico’s drug Regulatory guidelines and Mexico’s pharmaceutical regulations.
Classification of Medicinal Products in Mexico
Medicinal products are classified into the following categories.
- Chemical Synthesis Drugs (New Drug/New Chemical Entity and Generic Drug).
- Biological (New Entity and Generic Drug).
- Biotechnological (New entity and Biosimilar).
- Traditional Herbal Medicines.
Medicinal Product Registration in Mexico
Pharmaceutical product registration is carried out in the following steps:
Note - For a foreign manufacturer, it is mandatory to have an authorized representative for Mexico pharma Regulatory activities.
A) Marketing Authorization
- Submission of the application for ‘’Operation Notice’’ to “Centro Integral de Servicios” (CIS).
- Submission of the Marketing Authorization Application (MAA) and pharmaceutical dossier preparation.
- Validation, assessment, testing, and evaluation by relevant departments of the COFEPRIS.
- Review of the product pricing by the pricing department.
- Review of the approval request by the registration committee to grant the product license.
B) Verification and Abridged Procedure
This process will be applicable if the product has been approved and marketed by any of the following entities:
The United States Food and Drug Administration (USFDA), Health Canada, the European Medicines Agency (EMA), the Pharmaceutical and Food Safety Bureau (PFSB) of Japan, and the Australian Therapeutic Goods Administration (TGA), or another entity recognized by the COFEPRIS.
C) Waiver of Onsite GMP Inspection
Onsite GMP inspection can be waived if the manufacturing facility is approved by a COFEPRIS-recognized entity such as the USFDA, the EMA, Health Canada, the PFSB of Japan, and the Australian TGA, or another entity recognized by the COFEPRIS.
COFEPRIS allows the importation of non-registered products for the cases mentioned below:
- Essential drugs
- Security extraordinary cases
However, before importation, the local agent must obtain an import permit for each shipment from the COFEPRIS for pharmaceutical product registration.
Product Maintenance & Compliance
Validity for Registration Certificate
Five (05) years from the date of registration
Renewal of Registration certificate
The renewal application should be submitted six (06) months before the expiration of the existing registration certificate
Post Approval Changes (Variations)
Any change of registered medicine should be sent to the COFEPRIS with relevant documents, on a case-by-case basis.
Pharmaceutical Product Registration in Mexico - Freyr Expertise
- Regulatory Affairs Consulting and Pharma Market Access.
- End-to-end Pharmaceutical Product Registration.
- Authorized Local Agent Support.
- Pharma GMP Compliance Support.
- Dossier Gap Analysis as per the COFEPRIS Regulatory Requirements.
- Preparation of Gap Analysis Report and Remediation Plan.
- Pharmaceutical Dossier Preparation and Submission to the COFEPRIS.
- Mexico Pharma Regulatory Services.
- Query Support Management until Approval.
- Pharmaceutical Regulatory Services.
- Pharmaceutical Lifecycle Management Support.
- Pharmaceutical Artwork Management.
- Ad-hoc Mexico Regulatory Consultation.