Submit evaluation information to us electronically

eCTD helps Australian companies meet global regulatory requirements and offers:

• better version control
• easier navigation
• alignment with international standards
• streamlined assessment processes.

When to use eCTD

You must use eCTD to supply a prescription medicine- external site or submit a drug master file.

You may choose eCTD to:

• Supply a biological- external site
• Supply a non-prescription medicine- external site.

How to use eCTD

To learn the main terms and concepts for sending data to us in the eCTD format, read Glossary of terms for electronic Common Technical Document (eCTD).

For a step-by-step guide on submitting data in eCTD format, read Submit data in electronic Common Technical Document (eCTD) format.

For eCTD specifications and updates, read TGA Module 1 specifications for electronic Common Technical Document (eCTD) submissions.

You can use NeeS when eCTD is voluntary, but we encourage you to transition to eCTD wherever possible.

For a step-by-step guide on submitting data in NeeS format, read Submit data in Non-eCTD electronic submissions (Nees) format.

For NeeS specifications, read Specifications Non-eCTD electronic Submissions (NeeS) V.2.0.1.

Mandatory requirements for an effective application- external site.

General dossier requirements- external site.

For help with submitting a sequence, email eSubmissions@health.gov.au.

For help with eCTD specifications, email EDR@health.gov.au.