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Sharan Murugan
17 hours ago2 min read
Swissmedic Guidance: Orphan Drug Designation (ODS)
Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...
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Sharan Murugan
Jan 62 min read
Swissmedic Guidance: Parallel Import and Document Protection for Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has recently updated its guidance documents for " Parallel Import " and "...
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Sharan Murugan
Nov 3, 20242 min read
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...
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Sharan Murugan
Aug 31, 20242 min read
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway
The Swissmedic released an updated guidance " Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway " that provides...
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Sharan Murugan
Aug 26, 20242 min read
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...
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Sharan Murugan
Aug 3, 20242 min read
Swiss Medic: Guidance on Packaging for Human Medicinal Products
Swissmedic has issued detailed guidance on (01 August, 2024) on the "Packaging for Human Medicinal Products" to ensure their safety,...
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Sharan Murugan
Jul 23, 20242 min read
Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway
Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance " Electronic exchange of...
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Sharan Murugan
Jul 13, 20242 min read
Swissmedic Guidance: Product Information for Human Medicinal Products
The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...
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Sharan Murugan
Jul 3, 20242 min read
Swissmedic Guidance: Formal Requirements and SwissPAR
The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....
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Sharan Murugan
Jun 23, 20242 min read
Swissmedic Guidance: Requesting Product Certificates (CPP)
Swissmedic, the Swiss Agency for Therapeutic Products, has issued a detailed guidance document "Requesting Certificates of Pharmaceutical...
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Sharan Murugan
Jun 15, 20242 min read
Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)
Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...
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Sharan Murugan
Jun 9, 20242 min read
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...
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Sharan Murugan
May 18, 20242 min read
Switzerland’s Swissmedic: Guidance on Temporary Authorization to Use an Unauthorised Medicinal Product
Swissmedic, the Swiss Agency for Therapeutic Products, has provided guidelines on (15 May 2024) "Temporary Authorization to Use an...
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Sharan Murugan
May 6, 20242 min read
Switzerland's SwissMedic: Guidance for requesting Product Certificates (CPP)
On 3rd May 2024 Switzerland's Swissmedic released an updated guidance document "For requesting Product Certificates (CPP)" that guides in...
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Sharan Murugan
May 1, 20242 min read
Swissmedic Guidance: Import of a Human Medicinal Product (Parallel Import)
Today (01 May 2024) Switzerland's Swissmedic released updated guidance on "Import of a Human Medicinal Product according to Art. 14 para....
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Sharan Murugan
Apr 7, 20242 min read
Switzerland's SwissMedic: Guidance on Export Certificates
On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...
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Sharan Murugan
Mar 29, 20242 min read
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....
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Sharan Murugan
Feb 7, 20242 min read
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...
78 views0 comments
Sharan Murugan
Nov 26, 20232 min read
Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
36 views0 comments
Sharan Murugan
Nov 15, 20232 min read
Switzerland's SwissMedic: Guidance on Formal Requirements
On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...
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