Swissmedic Updates
The latest guidances, approvals, and safety alerts from Swissmedic, curated by automated regulatory intelligence.
Clarifies or updates Swiss guidance on the conditions and documentation expectations for importing human medicinal products under Art. 14 para.
Adaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances, indicating that regulatory expectations…
Revision of the Swissmedic guidance for authorisation of biosimilars may refine the regulatory expectations for demonstrating biosimilarity, including how…
Swissmedic Portal updates will introduce new online functionality available from 23 September 2026, requiring regulated entities to prepare for changes in how…
Defines or clarifies Swiss regulatory expectations for notifications submitted under Article 41 of the MPLO framework.
ElViS 2.0 appears to be a Swiss regulatory update focused on a system/process commonly used for regulatory interactions, but the provided document content does…
Webinar content likely provides an update on Swissmedic regulatory expectations, but the provided document text contains no substantive policy or procedural…
Simplifies Swissmedic application procedures for changing a veterinary medicinal product’s status between its main authorisation and an export licence.
FAQ on Swissmedic Fees Ordinance provides interpretive clarification on how Swissmedic fees are assessed and managed under the Fees Ordinance.
Changes to the questions and answers and guidance document on mobile technologies.
Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway.
Changes to the guidance document RMP ICH E2E information submission HMP.
Outlines an inspection checklist for assessing hospital compliance with medical device vigilance obligations, emphasizing how hospitals detect, manage, and…
Introduces new EU implementing GMP requirements that may tighten and harmonize quality system and manufacturing expectations for veterinary medicinal products…
Updates Swiss regulatory expectations regarding the introduction and use of eCTD v4.0 for electronic submissions.
Confirms Swissmedic’s competitiveness internationally by reporting findings from a CIRS study on authorisation timelines for human medicinal products…
Establishes that, from 1 July 2026, mandatory registration requirements apply to both medical devices and in vitro diagnostic medical devices under swissdamed.
Updates the Swissmedic annexes for TPLRO/TPLO-related documentation, likely refining or replacing previously stated submission and/or compliance expectations…
Updates Swissmedic template content for patient information and healthcare professional information for human medicinal products.
Launches a cross-agency targeted campaign for 2026 focusing on oversight activities related to peptides across the regulated lifecycle.