Regulatory Update: Swissmedic Expands Therapeutic Indication for Jaypirca®
Swissmedic has announced an extension of the therapeutic indication for Jaypirca®, a development that could impact clinical practice and regulatory…
Switzerland
Switzerland updates on medical device regulation and quality.
156 articles
156 articles in Switzerland
Europe
Europe
Swissmedic Announces Recall of Ringerfundin B. Braun Batch Due to Quality Issues
On January 10, 2026, Swissmedic issued an official recall notice regarding specific batches of Ringerfundin B. Braun Infusionslösung. This recall…
Europe
Swissmedic Announces Recall of Specific Batches of Esomeprazol MUT Sandoz Tablets
On January 10, 2026, Swissmedic issued an announcement concerning the recall of designated batches of Esomeprazol MUT Sandoz gastro-resistant tablets.…
Europe
Swissmedic Expands Therapeutic Indication Approval for Pemazyre®
Swissmedic, the Swiss agency responsible for the authorisation and supervision of therapeutic products, recently approved an extension for the therapeutic…
Europe
Temporary Approval for Sevelamer Carbonate 800 mg Tablets in German Packaging
Swissmedic has issued a temporary marketing authorization for Sevelamercarbonate Salmon Pharma 800 mg film-coated tablets in German packaging. This development…
Europe
Swissmedic Announces Paper Leaflet Alternatives for Veterinary Medicines Starting 2026
Swissmedic has announced a significant change in packaging requirements for certain veterinary medicinal products. Starting January 1, 2026, it will…
Europe
European Pharmacopoeia 12.1 Enforcement Date Announced: Key Implications for Compliance
On January 1, 2026, the European Pharmacopoeia version 12.1 officially comes into force. Regulatory professionals, quality assurance teams, and clinical…
Europe
Revised Annex 7 TPLRO Variations Take Effect February 2026
A key regulatory development for the healthcare sector is set to take place early next year. A revised list of…
Europe
Swissmedic Authorizes Temporary Distribution of Xenpozyme in Taiwanese Packaging
On January 10, 2026, Swissmedic announced the temporary authorization for the distribution of Xenpozyme Pulver zur Herstellung einer Lösung zur…
Europe
Swissmedic Highlights Medication Mix-Up: Phosphonorm® Erroneously Administered Instead of Phoscap
In a recent pharmacovigilance update dated January 10, 2026, Swissmedic reported an important issue regarding a specific medication mix-up involving…
Europe
Swissmedic Opens Recruitment for Product Owner Role in Regulatory Operations
Swissmedic, the Swiss agency responsible for therapeutic products, is seeking a Product Owner to join its Operational Support Services division.…
Europe
Swissmedic Offers Targeted GMP/GDP Consultations for Regulatory Clarity
On January 10, 2026, Swissmedic announced a dedicated platform for addressing specific questions related to Good Manufacturing Practices (GMP) and…
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