General communications


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


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


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

Swissmedic’s preliminary recommendation


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


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

41 human medicinal products with new active substances authorised


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

Number of illegally imported medicinal products remains at the same level


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


Updated requirements for dealing with potential nitrosamine impurities in medicinal products

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


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


Changes to the Guidance document Fast-track authorisation procedure

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


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


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


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


SFAO gives Swissmedic a doubly good report

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


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


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


New guidance document Drug safety signals VMP

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


Aufsichtsabgabe 2023 – Selbstdeklaration

Eingabefrist: 22. Januar 2024


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


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


Access Consortium’s Advanced Therapy Medicinal Products Working Group

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


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


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


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

Authorities checked shipments of medicinal products worldwide from criminal online sales


Falsified Ozempic diabetes medication in circulation

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


Health risks of designer drugs: further psychoactive substances prohibited

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


Spikevax XBB 1.5, Pre-filled Syringes

Clarification on the expiry date

Last modification 22.11.2022

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