8 April 2026
From the Swissmedic newsfeed, Arex Advisor has rounded up a selection of regulatory highlights from the past month.
Swissmedic aligns biosimilar approach with evolving EU guidance
1 March 2026
Swissmedic is aligning its approach to the authorisation of biosimilars with the latest scientific thinking reflected in the EMA draft reflection paper on tailored clinical development. The regulator supports efforts to optimise biosimilar development by reducing unnecessary clinical data requirements while maintaining robust standards for quality, safety, and efficacy. Read more
Updates to Swissmedic requirements for inhaled and topical respiratory medicines
1 March 2026
Swissmedic has revised its position on the authorisation of inhaled and topical preparations with known active substances for asthma and chronic obstructive pulmonary disease. The update aligns requirements with current scientific knowledge and international standards, supporting consistent evaluation of orally inhaled products used in respiratory care. Read more
Swissmedic updates guidance on product information requirements
1 March 2026
Swissmedic has revised its guidance on product information for human medicines, introducing updated requirements for presenting undesirable effects and drug interactions. The update also adds new expectations on environmental considerations and disposal, supporting more comprehensive and transparent product information. Read more
Updated Swissmedic guidance on decentralised clinical trials
9 March 2026
Swissmedic and swissethics have released version 4.0 of their position paper on decentralised clinical trials of medicinal products. The update revises the appendices to align with the latest European Commission recommendations on decentralised trial elements, supporting more consistent implementation of DCT approaches. Read more
How do these changes affect you?
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