2017年4月7日に下記の文書がupdateされました。

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

 

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064994.htm

 

REVISION HISTORY

Update to Guidance

Section I. Introduction

• Paragraph added describing rationale for changing timetable for required master file submissions in eCTD from 24 months to 36 months.

 

Section III.B. Timetable for Implementation of Electronic Submission Requirements

• Updated to reflect that the requirement for master files to be filed electronically takes place 36 months after May 5, 2015.
• Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.