Switzerland regulates health products through Swissmedic, the Swiss Agency for Therapeutic Products, which authorises medicines and supervises medical devices. As a non-EU country, Switzerland maintains its own therapeutic products law while closely tracking EU frameworks such as the MDR and IVDR, and changes to the mutual recognition arrangement have reshaped device market access. This page collects the Swiss regulatory updates HealthSignal tracks across medicines and devices, from official public sources only.
Mandatory registration of medical devices and in vitro diagnostic medical devices in the Swiss registry (swissdamed) enters into force.
Swissmedic · SwitzerlandSwissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · SwitzerlandUpdated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · Switzerland17.07.2026
Swissmedic · SwitzerlandSwissmedic updates guidance on risk management plan information submission under ICH E2E for human medicinal products.
Swissmedic · SwitzerlandEuropean Pharmacopoeia Edition 12.3 becomes effective on 1 July 2026.
Swissmedic · SwitzerlandTemplates for patient information and healthcare professional information for human medicinal products are being changed, effective 01.07.2026.
Swissmedic · Switzerland16.07.2026
Swissmedic · Switzerland01.07.2026
Swissmedic · SwitzerlandThe Swissmedic Journal is the official periodical of the Swiss Agency for Therapeutic Products and appears monthly, in German and French. It is published in the middle of the following month on this website. The Swiss...
Swissmedic · Switzerland06.07.2026
Swissmedic · SwitzerlandMarketing authorisation granted for mRESVIA®, an mRNA-based medicinal product.
Swissmedic · SwitzerlandSwissmedic summary report for MenQuadfi®, a meningococcal conjugate vaccine approved for active immunisation against invasive meningococcal disease from 6 weeks of age.
Swissmedic · SwitzerlandIn Abstimmung mit Swissmedic möchte die Zulassungsinhaberin Vifor Fresenius Medical Care Renal Pharma Ltd. über folgenden Sachverhalt informieren: Detaillierte Informationen dazu können dem PDF-Dokument entnommen werden.
Swissmedic · SwitzerlandMarketing authorisation granted for RYSTIGGO® (solution for injection) for treatment of generalised myasthenia gravis in adult patients with specific antibodies.
Swissmedic · SwitzerlandMarketing authorisation granted for Breyanzi® (lisocabtagene maraleucel), a chimeric antigen receptor T-cell therapy.
Swissmedic · SwitzerlandMarketing authorisation granted for Winrevair®.
Swissmedic · SwitzerlandMarketing authorisation granted for Enhertu® (trastuzumab deruxtecan), a human medicinal product.
Swissmedic · SwitzerlandMarketing authorisation granted for Enflonsia®.
Swissmedic · SwitzerlandVisible particles detected in some batches; pre-filled syringes must not be used if solution is cloudy or contains particles.
Swissmedic · SwitzerlandOpdualag 240mg/80mg concentrate for infusion is out of stock as of 09.07.2026.
Swissmedic · SwitzerlandSwissmedic grants temporary authorisation for distribution of Thiopental Inresa 0.5 g powder in German packaging.
Swissmedic · Switzerland22.07.2026
Swissmedic · SwitzerlandSwissmedic issued a batch recall for Mycostatin oral suspension 100,000 I.U./ml.
Swissmedic · SwitzerlandDirect Healthcare Professional Communication issued for domperidon-containing medicines regarding safety information.
Swissmedic · SwitzerlandKlinik Arlesheim AG recalls batches of Viscum album products due to incorrect labelling indicating injection use when products are not intended for injection.
Swissmedic · SwitzerlandMellozzan 0.5 mg tablets are out of stock as of 20 July 2026.
Swissmedic · SwitzerlandBetaseptic alcoholic povidone-iodine solution 1000 ml is out of stock.
Swissmedic · SwitzerlandVoranigo 10 mg film-coated tablets is out of stock as of 13 July 2026.
Swissmedic · Switzerland