From the Swissmedic newsfeed, Arex Advisor has selected the most important regulatory updates from the past month.
Swissmedic launches FAST-Track pilot for faster clinical trial reviews
1 May 2026
From May 2026, clinical trial applications for category B and C medicinal products approved for accelerated review by Swissmedic will also benefit from expedited assessment by the relevant ethics committee. The harmonised FAST-Track pilot aims to improve coordination between regulatory and ethical review processes, helping speed up clinical trial approvals while maintaining oversight standards. Read more
Swissmedic clarifies requirements for multi-sponsor clinical trials
11 May 2026
Swissmedic has published guidance on the compliant conduct of clinical trials involving multiple sponsors, including advanced therapy medicinal products. The document outlines the regulatory requirements that apply when responsibility is shared between sponsors, helping ensure clear governance and compliance in collaborative trial models. Read more
Swissmedic Vigilance News highlights pharmacovigilance trends and safety updates
7 May 2026
Edition 36 of Swissmedic Vigilance News covers a range of pharmacovigilance topics, including the use of natural language processing to improve detection of adverse drug reactions in hospital discharge summaries and emerging safety concerns linked to immune checkpoint inhibitors and tetracyclines. The issue also reviews Switzerland’s adverse drug reaction reporting obligations, implementation of the ICH E2D(R1) safety data management guideline, 2025 risk management activities, and annual pharmacovigilance reporting trends for human medicines. Read more
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