Regulatory Blog

Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...

Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated  guidance  on " Product Information for Human Medicinal...

The Swissmedic guidance released an information sheet titled " Combined Studies: Clinical Investigations of Medical Devices, Medicinal...

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...

Recntly Switzerland's Swissmedic provided essential information on guidance " Fast-Track Authorisation Procedure " and " Temporary...

Recently (01 October, 2024) Swissmedic released an updated guidance " Transfer of Marketing Authorisation " which provides detailed...

The Swissmedic released an updated guidance " Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway " that provides...

Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...

Swissmedic has issued detailed guidance on (01 August, 2024) on the "Packaging for Human Medicinal Products" to ensure their safety,...

Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance " Electronic exchange of...

The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...

The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....

Swissmedic, the Swiss Agency for Therapeutic Products, has issued a detailed guidance document "Requesting Certificates of Pharmaceutical...

Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...

Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...

Swissmedic, the Swiss Agency for Therapeutic Products, has provided guidelines on (15 May 2024) "Temporary Authorization to Use an...

On 3rd May 2024 Switzerland's Swissmedic released an updated guidance document "For requesting Product Certificates (CPP)" that guides in...

Today (01 May 2024) Switzerland's Swissmedic released updated guidance on "Import of a Human Medicinal Product according to Art. 14 para....

On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...

Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....