What is it?

The Electronic Common Technical Document (eCTD) is a standard for the electronic submission of regulatory information to regulatory agencies.

Where is the eCTD currently accepted?

Regulatory bodies in the U.S., Canada, European Union and Japan accept eCTD submissions.

Is it mandatory?

In the U.S., electronic submissions are “preferred” or “encouraged”, and for electronic submissions, eCTD is the only acceptable format. In many other countries, electronic submissions and the use of the eCTD format are “encouraged”. Over the long term, the eCTD is expected to become mandatory or near-mandatory.

What are some of the potential benefits – to the applicant - of using the eCTD now?

• compliance with the agency preference for this format
• reduced application review and approval time
• reuse of documents and content for amendments and for global submissions – efficient lifecycle management

What are the potential benefits to the regulatory agencies?

• increased reviewer efficiency and effectiveness
• more consistent review
• electronic workflow

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