EMA has updated its Q&A on practical arrangements for the companion diagnostics consultation procedure by notified bodies, covering letters of intent, IRIS submissions, rapporteur appointment, pre-submission interactions, eSubmission and fees.

Swissmedic has published Version 21.0 of its Formal Requirements guidance document, introducing updates and clarifications relating to medicinal product authorisation applications, documentation requirements, biosimilars, Article 13 TPA submissions and combination products incorporating medical devices.

Swissmedic has released Version 20.0 of its “Formal Requirements” guidance, effective 1 March 2026. Learn what pharmaceutical manufacturers need to know about submission formats, documentation requirements and parallel import updates.