Abstract
US FDA strongly encourages drug applicants to consider the implementation and use of data standards for the electronic submission of nonclinical and clinical research data to FDA in advance of their requirement. With regards to nonclinical research data, Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) has been developed by the Clinical Data Interchange Standards Consortium (CDISC) in order to propagate understanding and implementation of Standard for Exchange of Nonclinical Data (SEND) by expanding and modifying the Study Data Tabulation Model (SDTM) that is originally used for clinical submissions. US Food and Drug Administration (FDA) is receiving SEND data sets prior to the official implementation in 2016, and many pharmaceutical companies are probably utilizing SEND for data warehouses. These represent a trend illustrating the important role SEND is playing from the viewpoint of business strategy. Under such circumstances, more pharmaceutical companies are required to establish strategic procedures on electronic submission of nonclinical data to FDA in order to avoid the potential risks in the course of SEND data set preparation and acceptance by FDA. This article provides a general overview of worldwide trends on SEND implementation, and discusses the necessary measures taken by pharmaceutical companies and Contract Research Organizations (CROs) in Japan.
