15 June 2026
Swissmedic: Mandatory SEND dataset submission for new active substance authorisation applications
With effect from 15 June 2026, submission of non-clinical study data in SEND (Standard for the Exchange of Nonclinical Data) format is mandatory for new authorisation applications for human medicinal products with new active substances, where submission to the FDA is planned or has already been made. The requirement is based on art. 4 para. 3 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO) and aligns Swissmedic's practice with the FDA's current Data Standards Catalog, without requiring any additional data beyond what applicants already submit to the FDA. SEND datasets enable structured electronic analysis and support scientific evaluation, but applications continue to be assessed on the basis of full study reports in PDF format. Several specification documents have been updated accordingly, including the new authorisation application form and relevant guidance documents.
For more information, see here.
More News
-
-
Swissmedic: New strategic Approach to minimizing Animal Testing in the Development of Medicinal Products
-
Swissmedic: The new Pharmacopoea Helvetica 13
-
European Medicines Agency: New oral GLP-1 Medicine for Weight Management and Type 2 Diabetes
-
FOPH: Capital Income of Health Insurers for Premium Reduction – current voluntary System deemed sufficient
-
Decision C-6534/2024 of 13 October 2026
-
Swissmedic: Haemovigilance Annual Report 2025
-
Swissmedic: GMP Compliance by foreign Manufacturers - Simplifications for Industry and Clarification of unresolved Issues
-
European Medicines Agency: Clinical Trial Applications Advice Pilot becomes permanent
-
Swissmedic: Changes to the Guidance document “Import of a human medicinal product according to art. 14 para. 2 and 3 TPA (parallel import)”