The Pharma Legal Handbook: Mexico

Mexico is the second largest pharmaceutical market in Latin America and a strategic priority for companies building a regional presence. COFEPRIS, the Federal Commission for Protection against Sanitary Risk, manages product registration and post-market surveillance, while the Ministry of Health and the social security systems (IMSS and ISSSTE) are the dominant channels for public procurement.

Mexico operates a price control system for pharmaceutical products, with maximum public sale prices determined by reference to the country of origin and a defined basket of comparator markets. The public procurement market, including the IMSS and ISSSTE tender processes and the national compulsory licence framework, requires specific expertise to navigate.

The Pharma Legal Handbook: Mexico provides comprehensive guidance on pharmaceutical regulation in Mexico, covering COFEPRIS product registration, pricing frameworks, public procurement rules, clinical trial requirements, pharmacovigilance obligations, manufacturing standards, marketing rules, and intellectual property protection.