eCTD Important Notices

eCTD Important Notices – Food and Drug Administration

Important Note 4/7/2017 FDA Extends compliance date for submitting DMFs in eCTD format The FDA extended the compliance for submitting DMF’s in eCTD format to May 5, 2018.

Electronic Common Technical Document (eCTD)

Notice 4/24/2018 FDA Extends Compliance Date for Submitting DMF Type lll in eCTD format. The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2019.

eCTD Resources · Submit Using eCTD · Cder Data Standards Program · Drug Master Files (DMFs)

CDER/CBER’s eCTD standard format, beginning from May 5, 2017

Important Notices. Update to eCTD Technical Conformance Guide (PDF – added 10/19/2016) Update to PDF Specifications (PDF – added 10/3/2016)

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Module 1 IMPORTANT INFORMATION Electronic Common …

Prior eCTD M1 Public Meeting Information – Agenda, Presentations and Audio/Video Recordings (9/18/2012) IMPORTANT NOTE: NOT FOR IMPLEMENTATION AT THIS TIME The documents and files provided below are for planning and preparation purposes only.

Notice: Guidance Document: Preparation of Drug Regulatory

The Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format reflects comments received from stakeholders. The implementation and use of the eCTD format is a work in progress.

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CDER/CBER’s eCTD standard format, beginning from May 5, …

eCTD Documentation and Resources For a listing of Specifications, Supportive Files, M1 versions 1.3 and 2.3 documents related to eCTD, please refer to eCTD Submission Standards (XLS – 57KB) or eCTD Submission Standards (PDF – 91KB). CDER/CBER’s eCTD standard format, beginning from May 5, 2017

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eCTD Guidance Document – Europa

The structure and organisation of an eCTD submission is defined by the following standards: • ICH M2 eCTD Specification • EU Module 1 Specification • Relevant ICH and EU Q&A docs . Annex 1. contains links to the currently approved version of these documents. Typically, an eCTD application will cover all dosage forms and strengths of a product.

Regulatory Operations: Leveraging eCTD Benefits | RAPS

To ensure authors include all the relevant information, good templates will include an outline or baseline with references to the appropriate guidance documents. The global migration to eCTD is coming. As global health authorities migrate toward eCTD, sponsors able to establish robust processes and technology can harness the power of eCTD.

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General Overview of eCTD – ICH Official web site

General Overview of eCTD. Taku Watanabe. ICH M8 EWG Rapporteur. Pharmaceuticals and Medical Devices Agency ©2011 ICH. International Conference on Harmonisation of Technical Requirements. for Registration of Pharmaceuticals for Human Use.

eCTD v3.2 – eSubmission: Projects

The current version of the eCTD specification to be used for CTD modules 2-5 is the Electronic Common Technical Document Specification V3.2.2 (PDF). More information about the standard can be found at the ICH eCTD webpage .

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eCTD TECHNICAL CONFORMANCE GUIDE – eCTD Resource

eCTD . TECHNICAL CONFORMANCE GUIDE. Technical Specifications Document. notice announcing availability of this Guide and It is important to use a value for the submission-id that exists as a us-regional v2.01 sequence that has already been processed in the application.

Guidance Document: Preparation of Drug Regulatory

This guidance document is to be used in the preparation and filing of drug regulatory activities to Health Canada in the eCTD electronic-only format as established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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Consultation: Transition to eCTD only for prescription

reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that Transition to eCTD only for prescription medicines V1.1 October 2018 Page 3 of 18 eCTD specifications are important elements in obtaining the benefits of eCT D.

eCTD Revisions Published by FDA, Set for June 2014

In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering them a relatively straightforward way to file small variations on a single application to multiple