General communications

18.12.2024

Successful operation in control campaign against illegal trading in medicinal products

Swissmedic, the Federal Office for Customs and Border Security (FOCBS) and Swiss Sport Integrity (SSI) confiscated one quarter of more than 1,000 consignments checked

16.12.2024

Swissmedic: Vital hub in the joint campaign to combat therapeutic products crime

Five years as national single point of contact (SPOC) for Medicrime Convention

06.12.2024

Aufsichtsabgabe 2024 – Selbstdeklaration

Eingabefrist: 24. Januar 2025

04.12.2024

Public consultation for ICH Guideline M15 “General Principles for Model-Informed Drug Development” launched in Switzerland

Stakeholders in Switzerland have the possibility to comment on the draft of Guideline M15 “General Principles for Model-Informed Drug Development” until 28 February 2025

28.11.2024

Roundtable Hemato-Oncology

Quicker access to innovative cancer treatments: Swissmedic, the FDA and Swiss professional associations in dialogue

25.11.2024

Swissmedic awards its IT services to new provider Swisscom (Switzerland) Ltd

The outsourcing of IT services is intended to be long-term, for a period up to 2039

13.11.2024

Swissmedic warns: Illegal "Slimming preparations" and "detox products" can make you ill

Illegal slimming tablets or teas and detox products can contain undeclared harmful pharmaceutical substances such as sibutramine

05.11.2024

Combating designer drugs: Further psychoactive substances prohibited

Health risks of designer drugs: new psychoactive substances added to Narcotics List

01.11.2024

Clinical trials: Revised implementing regulations of the Human Research Act

The amended ordinances relating to the Human Research Act enter into force today

17.10.2024

Delivery of medicinal products to conflict areas

Exports of medicinal products to conflict regions should be organised by established aid organisations

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

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

Last modification 22.11.2022

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