Industry News
The latest medical device regulatory news, clinical trials, and market insights
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…
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…
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…
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…
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…
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…
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.…
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…
Swissmedic Approves Temporary Distribution of Enrylaze 10 mg Injection in Select EU Packaging
Swissmedic has granted a temporary authorization for the distribution of Enrylaze 10 mg/vial injection solution in distinct packaging formats from…
Swissmedic Issues Recall of Locametz 25 mcg Multidose Kits for Radiopharmaceutical Use
Swissmedic has announced a precautionary recall of specific batches of Locametz 25 mcg Multidose Kits for radiopharmaceutical applications. Clinical teams,…
FDA Alert: Nationwide Recall of Rheumacare Capsules Due to Dangerous Lead Levels
On January 10, 2026, Handelnine Global Limited, operating under the trade name Navafresh, announced a nationwide recall of their Rheumacare…
Federal Alert: Gold Star Distribution Recalls FDA-Regulated Products Citing Severe Contamination Risks
On December 26, 2025, Gold Star Distribution, Inc. issued a recall of multiple FDA-regulated products in response to serious contamination…