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Presented

Swissmedic 4.0 An update with the IT pros Christoph Jäggli and Nicolas Perez

The two IT professionals Christoph Jäggli and Nicolas Perez explain the developments regarding 4.0 at Swissmedic.

Accompanied

Swissmedic's inspection team On the road with Swissmedic's inspection team

Swissmedic's inspectors are not always welcomed with open arms – particularly if they’ve arrived unannounced. Nevertheless, Christian Schärer, head of Swissmedic’s inspection team, believes that companies should see inspections as an opportunity to demonstrate that they have the manufacture of their medicinal products fully under control.

Probed

Simplified authorisation Insights into complementary and herbal medicines

When it comes to the authorisation of medicines, the three requirements of quality, safety and efficacy are repeatedly mentioned. Do these requirements also apply to complementary and herbal medicines (CHMs)? We asked Martin Ziak, Margot Spohn and Bilkis Heneka from the CHM Team at Swissmedic. What is the status of CHMs in Switzerland, how do the requirements for CHMs differ from those relating to synthetic medicinal products, what are the various dispensing categories and how does the future look for complementary and herbal medicines?

Focused

Transparency at Swissmedic Visibility – Creating trust and closeness

The subject of transparency is more complex than it would seem at first glance – this also applies at Swissmedic. In fact, current events show just how important transparency is, and how trust and closeness can be created as a result. By publishing the Swiss Public Assessment Reports (SwissPAR), Swissmedic plays a key role in improving transparency. A special working group has been formed to develop the SwissPAR. We spoke with the group's head, Rosa Stebler, and with Martina Gerber, who coordinates and jointly edits the Public Summary SwissPAR.

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Facts & Figures

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Interview with Karoline Mathys

The new regulations for medical devices are primarily designed to improve patient safety, according to Karoline Mathys. In this interview, the Head of Market Surveillance at Swissmedic talks about the implications of the failed Framework Agreement with the EU, interdependencies with the EU regulations, collaboration with the European authorities and Switzerland's security of supply.

Investigated

New regulation since May 2021 Clinical trials with medical devices 2.0

Medical devices, for example knee replacements, artificial heart valves, catheters for internal procedures or software for MRI scanners, must be clinically tested before they can be placed on the market. New regulations on the corresponding requirements were introduced on 26 May 2021 and harmonised across Europe. Swissmedic's Isabel Scuntaro and Simone Frank are monitoring the new procedure. Using an example, they explain how the clinical trials are conducted.

Examined

A closer look at COVID-19 Trust the vaccine

Almost two years ago, the coronavirus appeared out of nowhere. Nevertheless, Swissmedic was well prepared. Thanks to short decision-making paths and a pragmatic approach, Swissmedic was one of the first authorities worldwide to authorise the Pfizer BioNTech vaccine, in mid-December 2020. A review of the current situation and the outlook for the future with the team headed by Julia Djonova, Head of the Transplants Unit in the Inspectorates and Licences Division at Swissmedic.