Overview of the Mexican
Regulatory Landscape
Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios), popularly known as COFEPRIS, is the National Health Authority in Mexico. COFEPRIS is the vertex of all Regulatory bodies governing the registration of Medical Devices, Cosmetics and Food Supplements, and Pharmaceutical Product Registration in Mexico. It is responsible for production, distribution, commercialization, imports and exports, advertisement, sales, and supply of these products. COFEPRIS has control over the general disposition, safety sanctions, sanitary control, and health promotions of all the medical products in the country.
Overview
The “Comisión Federal para la Protección Contra Riesgos Sanitarios” (COFEPRIS) is the key Drug Regulatory Authority in Mexico. Drug department of the COFEPRIS is responsible for handling and licensing of the manufacture, import, export, distribution, promotion, advertising, and pharmaceutical product registration. COFEPRIS is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and for monitoring the quality & safety of marketed medicinal products.
Classification of Medicinal Products
Medicinal products are classified into following categories.
- Chemical Synthesis Drugs (New Drug/ New Chemical Entityand Generic Drug)
- Biological(New Entity and Generic Drug)
- Biotechnological (New entity and biosimilar)
- Herbal Medicines
Medicinal Product Registration
Pharmaceutical Product registration is carried out in following steps
Note- For a foreign manufacturer, it is mandatory to have an authorized representative for Mexico Pharma Regulatory services
A) Marketing Authorization
Steps:
- Submission of the application for ‘’Operation Notice’’ to Centro Integral de Servicios” (CIS)
- Submission of the Marketing Authorization Application and pharmaceutical dossier preparation
- Validation, Assessment, Testing and Evaluation by relevant departments of COFEPRIS
- Review of the product pricing by the Pricing department
- Review of the approval request by the registration committee to grant Product Licence
B) Verification and Abridged Procedure
This process will be applicable if the product has been approved and marketed by any of the following entities: Health Canada, US FDA, EMA, the Pharmaceutical and Food Safety Bureau (PFSB) of Japan, the Australian Therapeutic Goods Administration or another entity recognized by COFEPRIS.
C) Waiver of Onsite GMP Inspection
Onsite GMP inspection can be waived if the manufacturing facility is approved by a COFEPRIS recognized entity: Health Canada, US FDA, EMA, the Pharmaceutical and Food Safety Bureau (PFSB) of Japan, the Australian Therapeutic Goods Administration or another entity recognized by COFEPRIS.