Mandatory submission of non-clinical study data in SEND format is established for new authorisation applications for NAS, effective 15 June 2026.
This change aims to standardize the initial safety data submitted in marketing authorisation dossiers, facilitating faster safety reviews and aligning with global standards such as those from the FDA and PMDA.
Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.
Regulatory Intelligence Lead
Review before 2026-06-15.
Mandatory use of SEND format for non-clinical safety data in marketing authorisation dossiers.
Ensures that initial safety data submitted in dossiers is standardized, facilitating faster safety reviews and alignment with global standards (FDA/PMDA). Affects the preparation of the clinical trial and marketing application dossiers.
Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.
Swissmedic has announced that beginning on 15 June 2026, it will be mandatory to submit non-clinical study data in SEND format for new authorisation applications concerning human medicinal products with new active substances, particularly if submission to the FDA is planned or has already been made.
What changed: Mandatory submission of non-clinical study data in SEND format is established for new authorisation applications for NAS, effective 15 June 2026.
Why it matters: This change aims to standardize the initial safety data submitted in marketing authorisation dossiers, facilitating faster safety reviews and aligning with global standards such as those from the FDA and PMDA.
Practical implication: Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.
Published from the Firecrawl policy change extraction pipeline.
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