Introduction and reflections on the non-clinical data exchange standard SENDA Story by MedicilonSEND 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 inSEND 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. © 2023 Medicilon |
StatsAuthorMedicilonCambridge, MAAboutMedicilon is an integrated contract research organization (CRO), providing comprehensive one-stop new drug R&D services for pharmaceutical enterprises and scientific research institutions around the w.. more..Writing
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