Swissmedic Introduces New Authorisation Pathway for Herbal Medicinal Products with Orphan Drug Status
What changed? Swissmedic has introduced a new authorisation pathway for herbal medicinal products with orphan drug status. This change aims…
Switzerland
Switzerland updates on medical device regulation and quality.
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156 articles in Switzerland
Europe
Europe
Swissmedic Introduces Machine-to-Machine Product Registration: What You Need to Know
What is M2M Product Registration? Starting from the end of March 2026, swissdamed playground will offer Machine-to-Machine (M2M) product registration…
Europe
Swissmedic Sees 17% Rise in Illegal Medicinal Product Imports from the EU in 2025
According to a recent announcement by Swissmedic, there has been a significant increase in the number of illegal imports of…
Europe
Swissmedic Initiates Batch Recall of Verkazia Augentropfen Emulsion
Swissmedic Initiates Batch Recall of Verkazia Augentropfen Emulsion Swissmedic, the Swiss agency for therapeutic products, has initiated a batch recall…
Europe
Swissmedic Clears Record Number of Human Medicinal Products with New Active Substances in 2025
On February 17, 2026, Swissmedic announced a milestone in the authorization of human medicinal products with new active substances and…
Europe
Swissmedic Issues Important Update on Cytosar (Cytarabinum): What You Need to Know
As of February 18, 2026, Swissmedic has released a crucial update regarding Cytosar (Cytarabinum), a medication used in the treatment…
Europe
Swissmedic Clears Ekterly®: A Breakthrough in Medical Devices
Swissmedic has granted its first authorization to Ekterly®, marking a significant milestone in the development of medical devices. As of…
Europe
Swissmedic Announces Archiving of Analgesic Medicinal Product Information Sheets
Published: 2026-02-11 Regulatory teams and medical device professionals should note the upcoming archiving of information sheets on specimen texts for…
Europe
Swissmedic Updates Guidance Document and Signal Notification Form for Drug Safety Signals
As of February 11, 2026, Swissmedic has comprehensively revised the Guidance document Drug Safety Signals HMP, modifying its structure and…
Europe
Swissmedic Updates Annex 7: Revised List of Variations Now in Effect
As of 1 February 2026, a revised list of variations according to Articles 21-24 of the Swiss Therapeutic Products Ordinance…
Europe
Safety Risks in Medical Device Treatments for Wrinkle Correction (‘Fillers’)
Meta Description: Swissmedic reports significant non-conformities in wrinkle treatment using medical devices. Published: 2026-02-11 Swissmedic’s recent focus campaign on therapeutic…
Europe
Temporary Permit for Distribution of Nemluvio Powder and Solvent for Solution for Injection in a Pre-filled Pen
Temporary authorization for distribution in German packaging A recent announcement by Swissmedic highlights a significant development in the distribution of…
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