{"entity":{"id":"swissmedic","kind":"institution","name":"Swissmedic","aka":["Swiss Agency for Therapeutic Products"],"tldr":"Swissmedic authorises medicines and devices in Switzerland and Liechtenstein; because Switzerland sits outside the EU it runs its own approvals, but it shares work with the FDA through Project Orbis and the Access Consortium and relies on decisions by comparable regulators.","summary":"Established in 2002, Swissmedic authorises and supervises medicines and medical devices in Switzerland and Liechtenstein. Because Switzerland sits outside the EU, it runs its own approval process, and it has joined international work-sharing through the FDA's Project Orbis, the Access Consortium and reliance procedures for products already approved by comparable regulators. It offers fast-track and temporary authorisation for medicines against serious diseases and regulates the advanced therapies produced by the Swiss pharmaceutical industry. Pricing and reimbursement are decided separately by the Federal Office of Public Health.","asOf":"2026-09-09","links":[{"label":"Swissmedic","url":"https://www.swissmedic.ch"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["roche-genentech","novartis"],"institutions":["fda-oce","ema","mhra","tga","health-canada"],"pathways":[],"terms":[],"trials":[],"people":["vincenza-trivigno"],"bottlenecks":["b-regulatory-fragmentation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Bern","country":"CH","lat":46.948,"lng":7.447,"institutionType":"government","website":"https://www.swissmedic.ch","programs":["Marketing authorisation and fast-track procedures","Project Orbis and Access Consortium","Reliance on foreign approvals","Market surveillance"]},"route":"/institutions/swissmedic/","neighbours":{"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"institution":[{"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/"},{"id":"health-canada","kind":"institution","name":"Health Canada","route":"/institutions/health-canada/"},{"id":"mhra","kind":"institution","name":"Medicines and Healthcare products Regulatory Agency","route":"/institutions/mhra/"},{"id":"tga","kind":"institution","name":"Therapeutic Goods Administration","route":"/institutions/tga/"}],"person":[{"id":"vincenza-trivigno","kind":"person","name":"Vincenza Trivigno","route":"/people/vincenza-trivigno/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}