{"entity":{"id":"cofepris","kind":"institution","name":"Comisión Federal para la Protección contra Riesgos Sanitarios","aka":["COFEPRIS"],"tldr":"Mexico's federal health regulator, which registers cancer medicines and has adopted reliance on FDA and EMA approvals to speed access.","summary":"COFEPRIS, part of Mexico's Secretaría de Salud, was created in 2001 and regulates medicines, devices, food and sanitary risks. It has implemented equivalence and reliance agreements that recognise approvals by the FDA, EMA, Health Canada and other reference regulators, shortening review times for new oncology drugs, and is recognised by the Pan American Health Organization as a regional reference authority. Public sector access depends on separate inclusion in the national formulary and procurement by IMSS, ISSSTE and the federal system, so registration is only the first hurdle for Mexican patients. COFEPRIS also regulates tobacco and clinical trial authorisation.","asOf":"2026-09-09","links":[{"label":"COFEPRIS","url":"https://www.gob.mx/cofepris"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["fda-oce","ema","anvisa"],"pathways":[],"terms":[],"trials":[],"people":["victor-hugo-borja-aburto"],"bottlenecks":["b-global-access","b-regulatory-fragmentation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Mexico City","country":"MX","lat":19.433,"lng":-99.133,"institutionType":"government","website":"https://www.gob.mx/cofepris","programs":["Drug registration and reliance on reference regulators","Clinical trial authorisation","PAHO regional reference authority","Tobacco and sanitary risk regulation"]},"route":"/institutions/cofepris/","neighbours":{"institution":[{"id":"anvisa","kind":"institution","name":"Agência Nacional de Vigilância Sanitária","route":"/institutions/anvisa/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"}],"person":[{"id":"victor-hugo-borja-aburto","kind":"person","name":"Víctor Hugo Borja Aburto","route":"/people/victor-hugo-borja-aburto/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}