SEND (Standard for the Exchange of Nonclinical Data) is a data format for preclinical studies that enables assessors, among others, to visualise the results of these studies.
The U.S. Food and Drug Administration (US FDA) requires the submission of SEND data for new authorisations according to their specifications in the Data Standards Catalog dated April 2024.
From 1 September 2024 data in SEND format can be submitted to Swissmedic for new authorisation applications for human medicinal products with new active substances. This will be particularly useful for applications for which the preclinical data has already been produced in SEND format for submission to the US FDA. Swissmedic does not require any additional data.
Swissmedic will continue to base its decisions primarily on the underlying study reports in PDF format. However, the use of SEND data sets enables effective and efficient analysis of data according to the latest state of science and technology.
In connection with the new options for submitting electronic data, Section 6.5 Data sets relating to studies has been added to the form New authorisation of human medicinal products and section 5.2.4 Non-clinical documentation (Module 4) has been revised accordingly in the guidance document Authorisation of human medicinal product with new active substance.
The revised specification documents are valid as of 1 September 2024.
The technical requirements for transmitting the SEND data sets are outlined in the linked publication Submission of accompanying documentation for applications for authorisation and variation for human medicinal products.