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258 articles
258 articles in Europe
Regulatory Affairs

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…

Regulatory Affairs

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…

Regulatory Affairs

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…

Regulatory Affairs

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…

Regulatory Affairs

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…

Regulatory Affairs

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…

Latest News

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…

Latest News

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…

Latest News

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…

Latest News

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…

Latest News

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…

Latest News

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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