medicines-medical devices-regulatory affairs
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
Last updated: 30 October 2025 To view updates, please click on the ‘+’ sign below: Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products to Version 3.3 of 27 October 2025. Unfortunately, no information has…
In this post, information is provided on the following updated guidance documents: Changes to the guidance document Time limits for authorisation applications Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active…
Last updated: 1 July 2025 To view updates, click on the link below: Switzerland is considered a leading research locations for clinical trials. What is at the core of the fast-track procedure? At the core of the fast-track procedure will…
Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents. Update 18 June 2025 Source: Swissmedic
To ensure that questions from companies relating to the development and approval of medicinal products can be clarified efficiently and purposefully in dialogue with Swissmedic, it has optimised the possibilities for company meetings. Source: Swissmedic
31 January 2025 The Canada-Switzerland MRA on Medicinal Products: Drug GMP Compliance Certification, Sectoral Annex on GMP has been in force since 2000. The text of the MRA has not yet been revised as this interpretation was possible on the…
The legal requirements for the maintenance of medical devices are regulated in: Swiss Good Practice for the Maintenance of Medical Devices (GPI) The “Swiss Good Practice for the Maintenance of Medical Devices” (GPI) is a guideline that explains the requirements…
Intensified exchange Swissmedic – Company in the labelling phase In order to avoid text review letters whenever possible, this direct exchange by means of an informal letter via the eGov portal should be used more frequently. Therefore, from January 1,…
The amended regulation on in-vitro diagnostic medical devices (IvDV) came into force on 1 January 2025. With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance…