What is eCTD in Regulatory Affairs?

All life science companies require approval from Regulatory Health Authorities to place their human, medical device or veterinary medicinal products on the market. Electronic common technical document (eCTD) is a mandatory format for submissions to Regulatory Health Authorities, which is set out by the ICH (International Council for Harmonisation).

The eCTD standard has evolved since its launch in 2003 to establish a global standard of drug application to the Regulatory Health Authorities, both from a technical and regulatory perspective. The eCTD 4.0 brings many efficiencies with the top 3 being; re-use of documents, correcting of metadata and lifecycle management.

The technical changes have resulted in regulatory authorities technically rejecting eCTD submissions with the FDA announcing   Specifications for eCTD Validation Criteria found in this guidance document. To summarise a high error is a serious technical error that prevents the processing of the submission meaning it will require resubmission. The submission is considered not received by FDA.

The key to every successful regulatory submission is to ensure each submission adheres to the eCTD format so that it is successfully validated, received, and reviewed by health authorities. This can be an overwhelming task when there are many contributors to the content and short deadlines to be met.  These tasks can present many challenges and risks if there is a lack of regulatory expertise and regulatory eCTD publishing. By working closely with the eCTD publishing team, this process is much easier for the Regulatory Affairs team. The top tips for a successful submission each time are:

  1. Regulatory Affairs team to keep all the contributors to the submission informed of the Agency deadlines
  2. Inform the eCTD publishing team of the eCTD deadline
  3. Complete the eCTD document plan which is most likely to be an excel spreadsheet, with a list of files to be submitted, their eCTD operation, hyperlinking required, with realistic dates when the files are to be finalised, date to provide to the eCTD publishing team, allow for Quality Checking time.
  4. Share the document plan with the eCTD publishing team, so they can plan with you to work together to meet the deadline
  5. Ensure to communicate any changes/delays of when the documents are to be finalised
  6. If necessary, have scheduled meetings with the eCTD publishing team to ensure the submission is on track to avoid any issues

The highly experienced eCTD publishing team at ONIX will ensure the submission is submitted successfully and on time.

Regulatory submissions can be complex with ever-changing regulatory requirements. Let ONIX take the worry out of your submissions to allow you to focus on drug development.


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