por Agustín Azcatl Under the amendment made to the Articles 168 and 170 of the Health Supplies Regulation, about the omission of the requirement for a manufacturing plant, last May 5, 2011, the Mexican Government granted the first Marketing Authorization (drug licensing) through the Health Ministry (The Federal Commission for Protection against Sanitary Risk COFEPRIS) to[...]

POR JUAN LUIS SERRANO Prompt and affordable access to essential medicines is a component of almost all domestic and global public health models. As is now well known, the availability and costs of both brand and generic drugs is a function of traditional patent law incentives. Less known, however, is that generic entry is controlled increasingly[...]

POR DANIEL SÁNCHEZ Y JUAN LUIS SERRANO MANAGING INTELLECTUAL PROPERTY, IP FOCUS LIFE SCIENCES 7TH EDITION 2009 For many years, Mexico lacked a particular regulation for biotherapeutic products, specifically those manufactured through biotechnology. Although these products were available for patients in the domestic market, their approval by the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) was[...]