Mexico's Pharmaceutical Regulations

Pharmaceuticals in Mexico are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios).  In Mexico Pharmaceuticals are classified based on Mode of Preparation, Origin, and Mode of Delivery.

Good Manufacturing Practices (GMP)
Document Number Document Title Issued by Description Available Languages Download
NOM-059-SSA1-2015 Good Manufacturing Practices of Medicines Ministry of Health The regulation lays down the minimum requirements necessary for the manufacturing process of medicines for human use marketed in Mexico and/or for research purposes. English For Sale