Introduction to eCTD in Regulatory Submissions

Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). It is also an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. Major countries, such as the US, Europe, Australia, Canada, South Africa, Thailand, and Japan, are using eCTD as a standard format for submissions of documents because of numerous advantages that it offers over the traditional submission method.

An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per the CTD structure below.

eCTD submissions are accepted for the following applications

• Investigational New Drug (INDs)

• New Drug Applications (NDAs)

• Abbreviated New Drug Applications (ANDAs)

• Biologics License Applications (BLAs)

• All the applications following the submission of the above-stated applications

• All the Master Files (MFs) which are part of any above-mentioned applications

For more information, please visit the eCTD page on the US FDA site here.

Mahin Arastu

Lead Medical Writer