New on this website

15.08.2025

Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products

The references in the position paper have been updated according to ICH-GCP E6 (R3) (new version 3.2)

12.08.2025

Summary report on authorisation – Scemblix®

Extension of therapeutic indication (01)

08.08.2025

Information sheet systems and procedure packs

The Information sheet outlines the obligations for the assembly and labelling of systems and procedure packs, as well as the associated obligations of economic operators in Switzerland and Liechtenstein

08.08.2025

Implementation in Switzerland of EU Commission Implementing Regulation on instructions for use in electronic form

Swissmedic is adopting the new EU requirements for the electronic provision of instructions for use for medical devices with immediate effect

07.08.2025

Drug-induced taste disorders

Learning from adverse reaction reports – cases from pharmacovigilance

07.08.2025

Swissmedic Journal

Latest edition
Swissmedic Journal Juli 2025

06.08.2025

International study on authorisation times confirms Swissmedic's competitiveness

Latest CIRS study rates Swissmedic's authorisation procedures for human medicinal products with new active substances as internationally competitive

05.08.2025

DHPC – Mitem® (mitomycinum)

Einführung eines Einwegfiltersystems für die intravenöse Verabreichung

05.08.2025

Summary report on authorisation – Ebglyss®

First authorisation

04.08.2025

DHPC – Entresto (sacubitrilum / valsartanum)

Fehlerhafte Angaben im Text der Packungsbeilage (Patienteninformation)

04.08.2025

Out-of-Stock – Ultiva 5 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Befristete Bewilligung zum Vertrieb in österreichischer Aufmachung

31.07.2025

Batch recall – Fucidin 250 mg Filmtabletten

Rückzug der Charge C98480 bis auf Stufe Detailhandel
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