Drug Evaluation Committee eCTD Creation Guide, Version 4.2 Gateway-compliant Version Published: August 1, 2016
Electronic Information Subcommittee
August 2016
In response to the trend toward digitization in the pharmaceutical industry, the Electronic Information Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (Drug Evaluation Committee Electronic Information Subcommittee) began distributing the "eCTD Creation Guide (4th Edition)" from the Pharmaceutical Publishing Center in August 2011, and many people are now making use of the Guide.
Since then, more than four years have passed, and some discrepancies have emerged between the descriptions and actual practice. In February 2016, the 4.1 edition was published, reflecting the latest information in Part 1 (basic information) and Part 2 (from preparation to approval of eCTD).
On the other hand, prior to the mandatory use of eCTD and the introduction of eCTD v4.0, the acceptance of electronic data (CDISC, etc.) for applications for approval will start from items submitted for approval on or after October 1, 2016. In addition, eCTD will be used in principle for the attached materials for the application for approval for the subject items, and in principle, these eCTD and electronic data for application will be submitted through the electronic data system for application (gateway system).
In light of this background, the procedures for submitting eCTD through the electronic data system for applications are described in this guide. Please refer to PMDA's "Electronic Data Application System Operation Manual - For Applicants -" released on June 29, 2016 for the parts related to the operation of the electronic data application system.
Considering that the eCTD and related information will change significantly and frequently in the future, we have decided to make it available only in electronic format.
We hope that you will find this Version 4.2 (Gateway-compliant version) useful and helpful in considering how to create eCTDs at your company.
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