On January 10, 2026, the U.S. Food and Drug Administration (FDA) announced an urgent recall of…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Regulatory Update: Swissmedic Expands Therapeutic Indication for Jaypirca®
Swissmedic has announced an extension of the therapeutic indication for Jaypirca®, a development that could impact…
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.…
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…
Swissmedic Expands Therapeutic Indication Approval for Pemazyre®
Swissmedic, the Swiss agency responsible for the authorisation and supervision of therapeutic products, recently approved an…
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…
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…
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…
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.…
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…