Switzerland regulates health products through Swissmedic, which authorises medicines and supervises medical devices. As a non-EU country it maintains its own therapeutic products law while tracking EU frameworks such as the MDR and IVDR, and changes to the mutual recognition arrangement have reshaped device market access.
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 requires electronic adverse drug reaction reporting via ElViS (E2B(R2)) or gateway (transitioning from E2B(R2) to E2B(R3) from Q3 2024).
Swissmedic · SwitzerlandSwissmedic publishes frequently asked questions explaining its practice on fee charging under the Fees Ordinance, effective 1 September 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 · SwitzerlandText elements no longer require revision, submission or approval for status-change applications between main authorisation and export licence for veterinary medicines from 1 September 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 · SwitzerlandThis year's “Regulatory & Beyond” event takes place on 16 November 2026 at the Kursaal, Bern. This event brings together experts from industry, authorities and other regulatory fields. The full programme is now availa...
Swissmedic · Switzerland13.08.2026
Swissmedic · Switzerland06.07.2026
Swissmedic · SwitzerlandSwissmedic authorised Livmarli® (odevixibat) oral solution for cholestatic pruritus in PFIC patients aged 12 months and older.
Swissmedic · SwitzerlandMarketing authorisation granted for Vyvgart® (efgartigimod alfa).
Swissmedic · SwitzerlandMarketing authorisation granted for Ojemda® (pharmaceutical product).
Swissmedic · SwitzerlandSwissmedic authorised the medicinal product Kisunla®.
Swissmedic · SwitzerlandMarketing authorisation granted for MenQuadfi®, a meningococcal vaccine.
Swissmedic · SwitzerlandRoche Pharma (Schweiz) AG and Swissmedic issue a direct healthcare professional communication regarding Alecensa (alectinib).
Swissmedic · SwitzerlandBatch 3258293B of Gabapentin 300 mg capsules has incorrect labelling: printed with 'Neurontin® 300 mg VLE' in blue instead of 'G 5027' in grey.
Swissmedic · SwitzerlandSwissmedic grants temporary authorisation for distribution of 58,474 units of Natulan 50 mg hard capsules in German packaging.
Swissmedic · SwitzerlandBatch recall issued for Movicol powder for oral solution.
Swissmedic · SwitzerlandExtencilline 1,200,000 and 2,400,000 IU powder and solvent for injection suspension is out of stock.
Swissmedic · SwitzerlandThiopental Inresa 0.5 g powder for injection/infusion solution is out of stock.
Swissmedic · SwitzerlandBatch recall of Viscum album Qu 200mg and Viscum album Qu-F 100mg ampoules.
Swissmedic · SwitzerlandMarketing authorisation granted for mRESVIA®, an mRNA-based medicinal product.
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 · SwitzerlandOpdualag 240mg/80mg concentrate for infusion is out of stock as of 09.07.2026.
Swissmedic · Switzerland