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General communications

19.10.2021

CureVac withdraws authorisation application for COVID-19 vaccine

Vaccine candidate CVnCoV no longer in rolling review procedure

15.10.2021

Reports of suspected adverse reactions to COVID-19 vaccines

8,757 reports of suspected adverse vaccination reactions (ADR) evaluated – the overall positive benefit-risk ratio of the vaccines remains

15.10.2021

Wichtige Mitteilung - Paclitaxel Sandoz 100 mg/16.7 ml, Konzentrat zur Herstellung einer Infusionslösung

Fehlerhafte Beschriftung

04.10.2021

New Head of Communication and media spokesperson at Swissmedic

Eliane Schmid has become Swissmedic’s new Head of Communication and media spokesperson.

28.09.2021

Vigilance for veterinary medicinal products: Adverse reactions reported in 2020

Report on adverse drug reactions (ADR) after use of veterinary medicinal products (VMP) in Switzerland

27.09.2021

Update – Warning about supposedly herbal products

Swissmedic is issuing an urgent warning regarding slimming products and other supposedly natural products

27.09.2021

Changes to the guidance document Formal requirements HMV4 and the form Import of a medicinal product according to Art. 14 (2) TPA (parallel import) HMV4

ZL_00_020e_WL / ZL106_00_002e_FO

24.09.2021

Reports of suspected adverse reactions to COVID-19 vaccines

7,571 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

21.09.2021

Practical interpretation – Swiss authorised representative (CH-REP) for combination products

(Medicinal products with a medical device component)

17.09.2021

Changes to guidance document Authorisation of human medicinal product with new active substance HMV4

ZL101_00_005e_WL

16.09.2021

Swissmedic is reviewing the authorisation extension for a third dose of the COVID-19 vaccines from Pfizer/Biontech and Moderna

Pfizer Schweiz AG and Moderna Switzerland GmbH have submitted applications for a third vaccine dose (booster)

15.09.2021

Access Consortium: Alignment with ICMRA consensus on immunobridging for authorizing new COVID-19 vaccines

Access Consortium members agree that well-justified and appropriately designed immunobridging studies are an acceptable approach for authorizing COVID-19 vaccines.

07.09.2021

More than 1,600 participants at the information event on the new medical devices regulation

Successful Swissmedic online event on 2 September 2021

03.09.2021

Reports of suspected adverse reactions to COVID-19 vaccines

6,603 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

01.09.2021

Changes to the guidance document Project Orbis HMV4

ZL000_00_048e_WL

01.09.2021

Update to the forms New authorisation of human medicinal products HMV4 and Variations and authorisation extensions HMV4

Consent to exchange of information for applications in collaboration with Access Consortium and Project Orbis

01.09.2021

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

ZL000_00_022e_WL

13.08.2021

Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update

5,304 reports evaluated – the overall positive benefit-risk ratio of the vaccines remains

11.08.2021

New Work Sharing Initiative from the Access Consortium for assessment of Biosimilar applications

Biosimilar Working Group (BSWG)

04.08.2021

Executive Summary - Benchmarking 2021

Comparison of Swiss approval times for human medicines with the EU and the USA

Last modification 19.04.2021

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