Swissmedic
Switzerland's medicines regulator, home to Roche and Novartis, and a member of Project Orbis and the Access Consortium.
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.
- Marketing authorisation and fast-track procedures
- Project Orbis and Access Consortium
- Reliance on foreign approvals
- Market surveillance
Pages like this
not linked directly; found by shared links- InstitutionComisión Federal para la Protección contra Riesgos Sanitarios
Shares European Medicines Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionPharmaceuticals and Medical Devices Agency
Shares European Medicines Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionAgência Nacional de Vigilância Sanitária
Shares FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionClinical Data Interchange Standards Consortium
Shares FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionUniversity Hospital Basel / Tumour Centre
Shares Novartis, Roche / Genentech.
- InstitutionNational Institute for Health and Care Excellence
Shares Medicines and Healthcare products Regulatory Agency, European Medicines Agency.
- CompanyMonte Rosa Therapeutics
Shares Novartis, Roche / Genentech.
- TargetWRN helicase (MSI-high cancers)
Shares Novartis, Roche / Genentech.