Regulatory Blog

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

On 18 August 2025, Swissmedic published Version 2.3 of its guidance on the " Submission Process for Clinical Trials with Medicinal...

The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify...

As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

On June 2, 2025 , Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical...

Switzerland’s regulatory landscape for pharmaceuticals continues to evolve, balancing patient safety with market efficiency. Two pivotal...

Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...

The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on " Export Certificates " effective 19 March...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, " Renewal, Discontinuation, and Status Change of...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance" Submission of Periodic Safety Update Reports...

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 recently updated its guidance documents for " Parallel Import " and "...

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

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...