Drug Evaluation Committee eCTD Creation Guide (Version 4.1)
Electronic Standard for Medical Information Expert Committee
February 2016
In response to the trend toward digitization in the pharmaceutical industry, the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association Electronic Standard for Medical Information Expert Committee(Drug Evaluation Committee Electronic Standard for Medical Information Expert Committee) began distributing the "eCTD Preparation Guide (4th Edition)" from the Pharmaceutical Publishing Center in August 2011, and many people have been making use of the Guide. More than four years have passed since then, and some discrepancies have emerged between the contents of the guide and actual practice. On the other hand, prior to the introduction of mandatory eCTD and eCTD v4.0, electronic data (CDISC, etc.) for applications for approval will be accepted from October 1, 2016 onward, and in principle, eCTD will be used for the attached materials for applications for approval for the subject items. In addition, in principle, eCTD and electronic data for applications will be submitted through the gateway system. In light of this background, Part 1 (Basic Information) and Part 2 (From Preparation to Approval of eCTD) have been updated to Version 4.1 to reflect the latest information available at this time.
Guide to the Preparation of Electronic Common Technical Documents (eCTD) [Version 4.1] (3.0MB)