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Swissmedic’s Guidnace: Understanding the Procedure With Prior Notification (PPN) and Environmental Conditions for Microbiological Examination of Non-Sterile Products
As regulatory systems evolve globally, Switzerland continues to harmonize and strengthen its medicinal product oversight through guidance that combines scientific rigor with procedural clarity. Two recent Swissmedic documents— the guidance on the Procedure with Prior Notification (PPN) and the technical interpretation on environmental conditions for microbiological examination of non-sterile products — together illustrate how Swiss authorities aim to improve both regulato
Sharan Murugan
Nov 29, 20253 min read
Swissmedic’s Guidance: Authorisation of Co-Marketing Medicinal Products
Companies increasingly turn to co-marketing partnerships in today’s highly competitive pharmaceutical landscape to expand product reach,...
Sharan Murugan
May 21, 20252 min read
Swissmedic Guidance on Product Information for Human Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance on " Product Information for Human Medicinal...
Sharan Murugan
Nov 16, 20242 min read
Swissmedic Guidance: Combined Studies: Clinical Investigations of Medical Devices, Medicinal Products, and Advanced Therapy Medicinal Products (ATMPs)
The Swissmedic guidance released an information sheet titled " Combined Studies: Clinical Investigations of Medical Devices, Medicinal...
Sharan Murugan
Nov 9, 20242 min read
Swissmedic Guidance: Fast-Track Authorisation Procedure and Temporary Authorisation for Human Medicinal Products
Recntly Switzerland's Swissmedic provided essential information on guidance " Fast-Track Authorisation Procedure " and " Temporary...
Sharan Murugan
Oct 27, 20242 min read
Switzerland's Swiss Medic Guidance: Transfer of Marketing Authorisation
Recently (01 October, 2024) Swissmedic released an updated guidance " Transfer of Marketing Authorisation " which provides detailed...
Sharan Murugan
Oct 6, 20242 min read