The electronic Common Technical Document usually abbreviated (eCTD) was intended to simplify regulatory submissions to regulators of drug approval. It provides a universal standard for pharmaceutical businesses to submit the required information required for approval of a new drug. The eCTD format is now being used in USA, Canada, Europe, and Japan.

It initially started as a well-structured paper based Common Technical Document format (CTD). It was well received and was broadly used. The eCTD format was an improvement of the CTD format. Both the CTD format and eCTD format were developed by the International Conference on Harmonization.  Health Canada is now accepting dossiers in the eCTD format.

Benefits of eCTD Format

eCTD Format training

The  format benefits sponsors, because dossiers are less expensive to process, store and to send out to regulatory agencies. The sponsor can also detect certain errors in the form of missed files easily.

The  format also benefits regulatory agencies. It helps dossier reviewers to be more efficient. The whole review process can be carried out online.

Since it was introduced, the eCTD format usage has been increasing steadily every year in USA, Canada, and Europe.

Current challenges and eCTD Format

How can a business know that it has complied with the eCTD format?  Regulatory agencies recommend  usage of validation software. Various regulatory bodies such as Health Canada and the FDA also use “validation software” to validate compliance with the requirements of the eCTD format. The validation criteria will continue to tighten.

Failure to pass the validation is likely to harm some businesses that are not aggressive in complying with the eCTD format requirements. We recommend that  businesses train their employees in the eCTD  before they purchase an eCTD software provider. Another training on the use of the software should follow before embarking on submitting an application for marketing authorization.

Training: eCTD Format

We will be offering hands-on training on the eCTD format requirements. We will review the CTD format as well as the regional mandatory documents. We will discuss the off-the-shelf software that you will use. You will learn how to use these pieces of software. The course will cover regional obligations for Canada, USA, and Europe. Your teachers will be experts with several years of experience.

This course is suitable for individuals with at least one year experience in the pharmaceutical industry in Quality assurance or Regulatory affairs. If you are not sure and would like to attend, please contact us.

We will offer this course in Toronto. More details will be sent for those who sign up below. Priority will be given to those who show interest early. We have limited seats as we cannot accommodate many people. We will  continue to publish more information on this web site.

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