Please Wait...

Required eCTD Submissions as of May 5, 2017 – Are You Ready?

The electronic common technical document (eCTD) is an interface for the pharmaceutical industry to transfer regulatory information based on the Common Technical Document (CTD) format, which is an agreed common format for applications that will be acceptable in all three ICH-Regions (US, EU & Japan) and other countries. The US is already accepting the electronic format submissions and for submissions that do not use eCTD will not be filed or received based on section 745(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) & Conformance Guide release in 2015 making the eCTD format mandatory for NDA, ANDA & BLA starting May 5, 2017 and for IND starting in May 2018. eCTD submissions are already mandatory in the EU and are accepted in Australia and Japan.

A common format for the technical documentation significantly reduces the time and resources needed to compile applications for registration of human pharmaceuticals, eases the preparation of electronic submissions, facilitates regulatory reviewers and communication with the application by a standard document of common elements and simplifies exchange of regulatory information between regulatory authorities.

These benefits are well recognized and underpin the decision to move to esubmissions. As part of the process, the Center for Drug Evaluation & Research (CDER) has initiated an acknowledgement to FDA Electronic Submissions Gateway (ESG) users with successful validation of an NDA, ANDA, BLA, IND or DMF submission; this acknowledgement will need to be part of your structured eCTD submission process.

Points that you will want to consider for esubmission readiness include:

  • Is there a set process to convert legacy reports and non-eCTD/paper dossiers to eCTD dossiers?
  • Is planning adequate to ensure that current submissions are ready for lifecycle management?
  • Are the right tools used for authoring and publishing eCTD submissions?
  • Can medium severity errors during validation be handled, to avoid “refuse to file” during the 60-day review period?

What are the next steps?

  1. Become familiar with the new standards
  2. Follow the technical specifications
  3. Plan to convert existing documents and use effective planners during the conversion process
  4. Acquire necessary permissions and accounts for ESG submissions
  5. Validate a sample submission and standardized data sets
  6. Reach out to service providers or appoint an SME to help plan and execute structured eCTD submissions

Bioclinica can help your organization at all steps in this process. Please contact me at barbara.clendenen@bioclinica.com for additional information.

eCTD Infographic

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

A great resource for Alzheimers's research teams. https://t.co/qhVP6ImwoO
bioclinica (12 hours ago)
RT @bioclinica: #Pharmacovigilance: Get up-to-speed on latest ind. trends & best practices + hear how others R meeting today's most pressin…
bioclinica (13 hours ago)
RT @Xtalks: Trends in #Pharmacovigilance – Market Research and Future Impact This webinar will discuss an overview of key findings within r…
bioclinica (13 hours ago)
RT @IntClinTrials: Patient loss and can reduced by introducing new methods during the follow-up period. Martin Collyer at @bioclinica tells…
bioclinica (13 hours ago)
@bioclinica experts talk candidly about #Alzheimer's research & where improvements can be made. Joyce Suhy, Marieke… https://t.co/u1Wmu41jRr
bioclinica (13 hours ago)
RT @ACROhealth: @MaryWolleyRA Mary Woolley @ResearchAmerica: 80% have heard of #clinicaltrials. 75% think trial participation is as importa…
bioclinica (1 week ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen