Introduction and reflections on the non-clinical data exchange standard SEND

 

         SEND stands for Standard for Exchange of Nonclinical Data, non-clinical data conversion standard. The US FDA released Providing Regulatory Submissions in Electronic Format — Standardized Study Data in December 2014. This document formally proposed the SEND standard for non-clinical data.

         SEND is not an independent standard, it is part of eCTD. Therefore, SEND was born in the context of electronic drug registration and submission in today's world. ICH released CTD (Common Technical Document) general technical document guidelines in 2000. CTD is a unified format for drug registration data, including drug quality controllability, safety and effectiveness. The first version of the eCTD Guidelines was released in 2003. eCTD is the electronic form of CTD, which is more convenient, environmentally friendly and efficient. Since the US FDA adopted eCTD in 2008, more than 40 countries/regions including the European Union, Japan, Canada and Australia have also implemented it.

Although my country has not yet begun to implement eCTD, electronic drug submission has many significant advantages over traditional paper submission. It is the general trend of international drug review and the development direction of my country's drug review. Therefore, it is very necessary to keep an eye on and understand the latest standards of international electronic filing.

1.Implementation Timetable

         The FDA officially issued the guideline on December 17, 2014. The guideline clearly stated that applications for NDA (New Drug Application), ANDA (Abbreviated New Drug Application) and some BLA (Biological License Application) were approved 24 months after the release of the guideline. Animal experiments started after December 17, 2016 must be submitted in the SEND format. For some IND (Investigational New Drug) applications, animal trials started 36 months after publication, that is, after December 17, 2017, must be submitted in the SEND format.

         In August 2017, the FDA announced its acceptance of SENDIG v3.1 (Standard Guidance for Nonclinical Data Conversion Version 3.1). NDA, ANDA and partial BLA applications, and trials starting after March 2019 must be submitted in accordance with the requirements of SENDIG v3.1. For partial IND applications, trials starting after March 2020 must be submitted in accordance with SENDIG v3.1.

2. Policies and regulations

The amount of data in pharmaceutical research is very huge, and integrating such huge data is a very complex task in itself. As a result, there are dozens of regulations and guidelines on electronic submission and data conversion, totaling more than 1,500 pages. This article focuses on several important documents.

Providing Regulatory Submissions in Electronic Format-Standardized Study Data. FDA officially released the SEND standard from this document.

STUDY DATA TECHNICAL CONFORMANCE GUIDE. This document is also issued by the FDA. This guidance provides instructions, recommendations, and general considerations for how to submit standardized trial data using FDA-accepted data standards. As a supplement to the previous document, it provides technical advice to companies on how to submit human and animal test data and related information in a standard form when filing for IND, NDA, ANDA and BLA. The purpose is to enhance mutual communication between submitters and FDA review departments. It is a very valuable reference document for understanding SEND.