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