SEND datasets for new authorisation applications for human medicinal products with new active substances

From 15 June 2026, submission of non-clinical study data in SEND format for new authorisation applications for human medicinal products with new active substances will be mandatory if submission to the FDA is planned or if the submission has already been made.

In the information published on its website on 1 September 2024, Swissmedic announced that submission of non‑clinical study data in SEND format is possible for new authorisation applications for human medicinal products with new active substances.

Pursuant to Article 4 paragraph 3 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO), this requirement becomes mandatory with effect from 15 June 2026. It applies to authorisation applications for human medicinal products with new active substances if submission to the FDA is planned or the submission has already been made. Swissmedic is therefore not requiring additional data but following the current Data Standards Catalog of the U.S. Food and Drug Administration (US FDA).

SEND (Standard for the Exchange of Nonclinical Data) is a standardised electronic data format for non‑clinical studies and enables structured, transparent and efficient evaluation of study data according to the latest state of science and technology. The SEND datasets are used for additional electronic analysis and support the scientific evaluation. Applications continue to be assessed on the basis of the full study reports in PDF format.

Amendment of specification documents

The following documents have been amended in connection with the mandatory submission of SEND datasets:

• Form “New authorisation of human medicinal products”
  Addition of section 6.5 Datasets relating to studies
  
  
• Guidance document “Authorisation of human medicinal product with new active substance (NAS)”
  Revision of section 5.2.4 Non-clinical documentation (Module 4)
  
  
• Directory “Overview of documents to be submitted”
  Adaptation of the “New authorisation” tab under Module 2-5 Scientific documentation

• Guidance document “Formal requirements”
  Section 3.6 Authorisation of new active substances

The mandatory submission of SEND datasets applies from 15 June 2026.

Technical requirements

The technical requirements for transmitting SEND datasets are outlined in the publication Submission of accompanying documentation for applications for authorisation and variation for human medicinal products and must be observed.