General communications

01.10.2024

The “Public Summary SwissPAR” is now called the “Summary report on authorisation”

Swissmedic is changing the name of the “Public Summary SwissPAR” to the “Summary report on authorisation”

17.09.2024

International meeting of the Permanent Forum on International Pharmaceutical Crime

International trends were discussed and the collaboration was strengthened

16.09.2024

New implementing regulations apply as of 1 November 2024

Swissmedic publishes instructions on the procedure for submitting applications

13.09.2024

Bluetongue: no authorised vaccines against serotype 3 in Europe

Swissmedic has not received any relevant applications. The assessment of such applications will be given top priority

01.09.2024

New form No marketing / interruption of distribution for veterinary medicinal products

A new separate form has been created for notification of no marketing and interruption of distribution for veterinary medicinal products.

01.09.2024

Electronic data sets from pivotal bioequivalence studies

From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation

01.09.2024

Mobile technologies – Submission of films as additional information regarding the safety, efficacy and quality of medicinal products

From 1 September 2024, Swissmedic will be accepting the submission of films as part of the authorisation of QR codes

01.09.2024

Guidance document Packaging texts for veterinary medicinal products

The guidance document Packaging texts for veterinary medicinal products has been revised

01.09.2024

SEND data sets for new authorisation applications for human medicinal products with new active substances

From 1 September 2024, Swissmedic is accepting SEND data sets for applications for new authorisation for human medicinal products with new active substances

01.09.2024

Combined studies

New forms and a new information sheet for submissions to Swissmedic

01.09.2024

Changes to the guidance document Time limits for authorisation applications

To standardise practice, written notification regarding the “Doc. OK” milestone will in future no longer be sent following a formal objection

28.08.2024

Update – Warning about supposedly herbal products

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

26.08.2024

Responsible Person: requirements (I-SMI.TI.17e)

Numerous clarifications have been made in the new version

05.08.2024

Sarco suicide capsule does not fulfil definition of a therapeutic product

Swissmedic has made an initial assessment of the Sarco suicide capsule according to therapeutic products legislation

02.08.2024

Swissmedic authorises dengue fever vaccine

Qdenga (powder and solvent for solution for injection in a pre-filled syringe) can be placed on the market in Switzerland

24.07.2024

Benchmarking study 2023

International comparison of Swiss authorisation times

12.07.2024

Public consultation for ICH Guideline M14 launched in Switzerland

Swissmedic launches the public consultation on Guideline M14 “Bioequivalence for Immediate-Release Solid Oral Dosage Forms General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines” of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 30 August 2024 for comments

11.07.2024

The European Pharmacopoeia is abolishing testing on rabbits

Pyrogen tests without rabbits: the European Pharmacopoeia is dispensing with animal testing

05.07.2024

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

COVID-19 vaccinovigilance reports up to the end of June 2024

02.07.2024

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

Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities

01.07.2024

TPLRO, TPLO: Update of annexes

Update of the TPLRO and TPLO annexes

01.07.2024

Ordinance 3 on Measures to Combat the Coronavirus (COVID-19) ceases to apply as of 30 June 2024

As there will no longer be any legal basis for doing so, Swissmedic will cease granting exceptions with regard to the authorisation and importing of medicinal products for the treatment or prevention of COVID-19

01.07.2024

Standardisation of practice on publication of indications in Swiss Public Assessment Report

The new practice and the revised Guidance document SwissPAR come into effect on 1 July 2024

01.07.2024

Fee reduction for non-commercially funded clinical trials

Swissmedic is reducing the fees for processing applications to non-commercially funded clinical trials by 80% effective 1 July 2024.

26.06.2024

ICH call for vendor participation now open

A call for vendor participation has now been published on the official ICH website

19.06.2024

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

Continued advancement of ICH’s global harmonisation efforts in Fukuoka, Japan

15.06.2024

Simplification of requirements for renewed authorisation of medicinal products

Swissmedic has simplified the requirements for renewed authorisation of medicinal products

10.06.2024

Better representation of women in medical research

Federal Council decides on measures to improve healthcare for women

Last modification 22.11.2022

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