General communications

18.04.2024

Swissmedic receives grant from the Bill & Melinda Gates Foundation

Grant agreement signed to continue supporting regulatory authorities in low and middle-income countries for a further three years

26.03.2024

Swissmedic issues warning about the illegal medicinal product "Lemon Bottle" lipolysis solution

"Lemon Bottle" lipolysis solution is not approved for distribution in Switzerland and must not be sold or used

06.03.2024

Fennel tea for pregnant women, infants and children under 4 years

Swissmedic’s preliminary recommendation

04.03.2024

Public consultation on ICH Guideline E2D(R1) launched in Switzerland

Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

12.02.2024

Authorisations of human medicinal products with a new active substance and additional indications 2023

41 human medicinal products with new active substances authorised

08.02.2024

Illegal imports of medicinal products: Erectile stimulants account for more than two-thirds

Number of illegally imported medicinal products remains at the same level

01.02.2024

Voluntary prior notification of new applications with new active substance for human medicinal products

Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications

30.01.2024

Updated requirements for dealing with potential nitrosamine impurities in medicinal products

Risk assessment measures for nitrosamine drug substance-related impurities (NDSRI) further specified

15.01.2024

Changes to the guidance document Temporary authorisation of human medicinal products

Clarification of the term "equivalent medicinal product" and timing of criteria assessment for temporary authorisation

15.01.2024

Changes to the Guidance document Fast-track authorisation procedure

Optimisation of the application procedure for the implementation of a fast-track authorisation procedure (FTP)

15.01.2024

Changes to the guidance document Authorisation of human medicinal products under Art. 13 TPA

The guidance document Authorisation of human medicinal products TPA and the form Information for application Art. 13 TPA have been revised

15.01.2024

Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak

Publication of new guidance document on procedures for authorising immunological veterinary medicinal products in the event of an epizootic outbreak

15.01.2024

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA updated

Explanations regarding dispensing category classification and clarification of the requirements for the application documentation for authorisations according to Art. 14 para. 1 letter abis-quater TPA

10.01.2024

SFAO gives Swissmedic a doubly good report

Swissmedic is efficient, competitive and fit for purpose according to SFAO

01.01.2024

New guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)

Simplification of parallel imports of human medicinal products already authorised in Switzerland

18.12.2023

Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn

The manufacturer Novavax is no longer pursuing marketing authorisation for its COVID-19 vaccine in Switzerland

07.12.2023

New guidance document Drug safety signals VMP

The new guidance document and the form for submitting signals for veterinary medicinal products are now available

01.12.2023

Aufsichtsabgabe 2023 – Selbstdeklaration

Eingabefrist: 22. Januar 2024

27.11.2023

Warning about imports of melatonin and DHEA by private individuals

Self-prescribed use of sleep hormones or supposed "anti-ageing" products can be harmful to health

13.11.2023

Meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Excellent Progress made on ICH harmonisation activities in Prague, Czech Republic

06.11.2023

Access Consortium’s Advanced Therapy Medicinal Products Working Group

In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs)

01.11.2023

Swissmedic confirmed as WHO Listed Authority

Swissmedic, already considered as stringent regulatory authority, is now listed as a WHO Listed Authority (WLA) and recognised in all regulatory functions

01.11.2023

Revision of MedDO and IvDO

When the changes entered into force on 1 November 2023, Swissmedic updated its website in this regard and published implementation guides

31.10.2023

Operation Pangea XVI: International campaign against falsified and illegally imported medicinal products

Authorities checked shipments of medicinal products worldwide from criminal online sales

09.10.2023

Falsified Ozempic diabetes medication in circulation

The Regional Council in Freiburg im Breisgau, Germany, has warned against the use of counterfeit Ozempic® pens

09.10.2023

Health risks of designer drugs: further psychoactive substances prohibited

Ten individual substances and one substance group added to the Narcotics List

06.10.2023

Spikevax XBB 1.5, Pre-filled Syringes

Clarification on the expiry date

Last modification 22.11.2022

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