Standard for exchange of non-clinical data (SEND): proof-of-concept study

The European Medicines Agency (EMA) makes a Standard for Exchange of Non-clinical Data (SEND datasets) format available to marketing authorisation holders. The SEND proof-of-concept study provides the option to voluntarily submit non-clinical data as part of an initial centralised marketing authorisation.

The Standard for Exchange of Non-clinical Data (SEND datasets) provides an electronic, structured format for submitting non-clinical raw data as part of an application for initial centralised marketing authorisation.

The SEND datasets offer a standardised way to visualise raw non-clinical data. They also replace the manual processing of PDF files containing scientific summaries and study reports.

Marketing authorisation holders who submit SEND datasets can benefit from the following advantages:

• Faster CHMP review of non-clinical data packages thanks to the standardised way of visualising data
• Enhance CHMP assessments through more advanced analysis of non-clinical data
• Smoother interactions between regulators and applicants, and fewer requests for additional information

EMA is running a proof-of-concept study to evaluate the feasibility and advantages of adopting the SEND datasets in the assessment of initial centralised marketing authorisations. This study will run until further notice.

A questions-and-answers document for applicants is available below. It includes information on the terms of participation and the technical details on how to submit SEND datasets.

Questions and answers about the SEND proof-of-concept for industry: Scope, terms of participation and data submission process

For more information, see:

• Marketing authorisation guidance documents

Scope of SEND study

The proof-of-concept study mainly focuses on the analysis of non-clinical safety data related to an initial marketing authorisation application. This includes:

• Single and repeat dose toxicity studies
• Safety pharmacology studies
• Developmental and reproductive toxicity studies
• Carcinogenicity studies
• Juvenile animal studies

There are no restrictions in relation to the disease area, therapeutic indication, or type and number of non-clinical studies that the applicant may submit.

How to participate in the SEND study

EMA encourages the voluntary participation of applicants of initial centralised marketing authorisations in the SEND proof-of-concept study. 

Inclusion of a regulatory procedure in the study does not delay CHMP's scientific opinion.

Applicants wishing to participate should submit their non-clinical data in both SEND datasets and the electronic common technical document (eCTD) format. Participation in the proof-of-concept study does not eliminate the need for an eCTD submission. 

CHMP rapporteurs appointed to evaluate the regulatory procedure decide whether the procedure is suitable for inclusion in the study.

They can also request the submission of raw data via SEND datasets during their assessment, in line with Article 7(c) of Regulation (EC) No 726/2004.

How to submit a SEND dataset

Applicants should submit the SEND datasets via the eSubmission website.

For more information on how to submit a SEND dataset, please refer to the questions-and-answers document available at the top of this page.

Contact point

For further questions on the proof-of-concept study, applicants can contact EMA via [e-mail].